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ASSESSING THE EFFECTIVENESS OF PATIENT EDUCATION

IN POST OPERATIVE PAIN MANAGEMENT

DISSERTATION WORK SUBMITTED TO

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA,


BANGALORE
IN PARTIAL FULLFILLMENT FOR THE AWARD OF DEGREE OF

DOCTOR OF PHARMACY
2019-2020

Submitted by

CHIRUDEEP P (15Q3104)
CHERIAN DAVID (15Q3103)
ANUSHA K (15Q3101)
PRADEEP J (15Q3120)

Under the guidance of

Prof. POORNIMA N B Dr. MUTHUKUMAR M, Pharm.D


Professor Assistant professor
Department of Pharmacy Practice Department of Pharmacy Practice

HILLSIDE COLLEGE OF PHARMACY RESERCH CENTER, BANGALORE -560062


(2019-2020)
DEPARTMENT OF PHARAMCY PRACTICE
HILLSIDE COLLEGE OF PHARMACY AND RESEARCH CENTRE
APPROVED BY PCI, AICTE
BANGALORE-560062
(2019-2020)

CERTIFICATE BY THE GUIDE

This is to certify that the thesis entitled “ASSESSING THE EFFECTIVENESS OF PATIENT
EDUCATION IN POST OPERATIVE PAIN MANAGEMENT” is a bonafide research work
done by CHIRUDEEP P (15Q3104) , ANUSHA K (15Q3101) , CHERIAN DAVID (15Q3103)
, PRADEEP J (15Q3120) in partial fulfilment of the requirement for the award of degree of
Doctor of Pharmacy in the Department of Pharmacy Practice. The research work was carried
out in BGS-GIMS Hospital and submitted to Rajiv Gandhi university of Health and Sciences,
Bangalore, under the supervision and guidance of Prof. POORNIMA N B, Department of
Pharmacy Practice, Hillside College of pharmacy and research centre, Raghuvnahalli, during
the academic year 2019-2020. The results embodied in this thesis have not been submitted to any
other university or institute for the award of any degree or any diploma.

Prof. POORNIMA N B,
Department of pharmacy practice,
Hillside College of pharmacy and research centre,
Raghuvnahalli, Bangalore.
DEPARTMENT OF PHARAMCY PRACTICE
HILLSIDE COLLEGE OF PHARMACY AND RESEARCH CENTRE
APPROVED BY PCI, AICTE
BANGALORE-560062
(2019-2020)

CERTIFICATE BY CO-GUIDE

This is to certify that the thesis entitled “ASSESSING THE EFFECTIVENESS OF PATIENT
EDUCATION IN POST OPERATIVE PAIN MANAGEMENT” is a bonafide research work
done by CHIRUDEEP P (15Q3104) , ANUSHA K (15Q3101) , CHERIAN DAVID (15Q3103)
, PRADEEP J (15Q3120) in partial fulfilment of the requirement for the award of degree of
Doctor of Pharmacy in Department of Pharmacy Practice. The research work was carried out
in BGS-GIMS Hospital and submitted to Rajiv Gandhi university of Health and Sciences
Bangalore, under co-guidance of Dr. MUTHUKUMAR M. Department of Pharmacy Practice,
Hillside College of pharmacy and research centre, Raghuvnahalli, during the academic year
2019-2020. The results embodied in this thesis have not been submitted to any other university or
institute for the award of any degree or any diploma.

Dr.MUTHUKUMAR M, Pharm D,
Department of pharmacy practice,
Hillside College of pharmacy and research centre,
Raghuvnahalli, Bangalore.
DEPARTMENT OF PHARAMCY PRACTICE
HILLSIDE COLLEGE OF PHARMACY AND RESEARCH CENTRE
APPROVED BY PCI, AICTE
BANGALORE-560062
(2019-2020)

ENDORSEMENT BY HEAD OF DEPARTMENT

This is to certify that the thesis entitled “ASSESSING THE EFFECTIVENESS OF PATIENT
EDUCATION IN POST OPERATIVE PAIN MANAGEMENT” is a bonafide research work done
by CHIRUDEEP P (15Q3104) , ANUSHA K (15Q3101) , CHERIAN DAVID (15Q3103) ,
PRADEEP J (15Q3120), in partial fulfilment of the requirement for the award of degree of doctor
of pharmacy in department of pharmacy practice. The research work was carried out in BGS-
GIMS Hospital and submitted to Rajiv Gandhi university of Health and sciences Bangalore, under
supervision and guidance of Dr. JESINDHA BEYATRICKS, Head of Department of pharmacy
practice, Hillside College of pharmacy and research centre, Raghuvnahalli, during the academic
year 2019-2020. The results embodied in this thesis have not been submitted to any other university
or institute for the award of any degree or any diploma.

Dr. JESINDHA BEYATRICKS, M. pharm, PhD,


Head Department of pharmacy practice,
Hillside College of pharmacy and research centre,
Raghuvnahalli, Bangalore.
DEPARTMENT OF PHARAMCY PRACTICE
HILLSIDE COLLEGE OF PHARMACY AND RESEARCH CENTRE
APPROVED BY PCI, AICTE
BANGALORE-560062
(2019-2020)

ENDORSEMENT BY PRINCIPAL/ HEAD OF INSTITUTE

This is to certify that the thesis entitled “ASSESSING THE EFFECTIVENESS OF PATIENT
EDUCATION IN POST OPERATIVE PAIN MANAGEMENT” is a bonafide research work done
by CHIRUDEEP P (15Q3104) , ANUSHA K (15Q3101) , CHERIAN DAVID (15Q3103) ,
PRADEEP J (15Q3120), in partial fulfilment of the requirement for the award of degree of doctor
of pharmacy in department of pharmacy practice. The research work was carried out in BGS-
GIMS Hospital and submitted to Rajiv Gandhi university of Health and sciences Bangalore, under
supervision and guidance of Dr.SRI HARSHA, principal, Hillside College of pharmacy and
research centre Raghuvnahalli, during the academic year 2019-2020. The results embodied in
this thesis have not been submitted to any other university or institute for the award of any degree
or any diploma.

Dr. SRI HARSHA


Principal
Hillside College of pharmacy and research centre
Bangalore-560062
DEPARTMENT OF PHARAMCY PRACTICE
HILLSIDE COLLEGE OF PHARMACY AND RESEARCH CENTRE
APPROVED BY PCI, AICTE
BANGALORE-560062
(2019-2020)

DECLARATION BY THE CANDIDATE

We declare that the present work entitled “ASSESSING THE EFFECTIVENESS OF PATIENT
EDUCATION IN POST OPERATIVE PAIN MANAGEMENT” for the award of DOCTOR OF
PHARMACY degree comprises of the bonafide research work carried out by me at BGS-GIMS
Hospital under the supervision of Prof. POORNIMA N B, Department of pharmacy practice, and
co-supervision of Dr. MUTHUKUMAR M. The work is original and the thesis either in part or
full does not constitute any part of any thesis/ dissertation/ monograph submitted by us or any
other person to any university/institute.

CHIRUDEEP P (15Q3104)

ANUSHA K (15Q3101)

CHERIAN DAVID (15Q3103)

PRADEEP J (15Q3120)
ETHICAL COMMITTEE APPROVAL
ACKNOWLEDGEMENT
ACKNOWLEDGEMENT

First of all we are thankful to God Almighty and our parents for their blessing and
unceasing encouragement and support in successful completion of the dissertation work.

The immense satisfaction and euphoria that accompany the successful completion of any
task would be incomplete without mentioning of the people who made it possible, whose
constant guidance and encouragement crows all the effort with success.

We would like to express our profound deep sense of gratitude and heartfelt cordial
thanks to our respected, honourable guide Prof.Poornima N B and co-guide
Dr.Muthukumar M, Department of Pharmacy Practice, Hillside College of Pharmacy
and Research Centre, Bangalore for inspiring us to successfully carry out this project.
They not only provided us valuable intellectual guidance, innovative and constructive
ideas in shaping the dissertation and its development but also gave us complete
independence, encouragement, constant scrutiny and timely advice to make the
dissertation successful.

We are extremely thankful and indebted to Dr. Sri Harsha, Principal, Hillside College of
Pharmacy and Research Centre, Bangalore, who has given us constant backup, whole
hearted support and encouragement for our research work, by providing us with all the
facilities and necessary infrastructure that has led to successful completion of our thesis.

We would also like to thank Dr..Jesindha Beyatrics Professor and HOD, Department of
Pharmacy Practice, Hillside College of Research Centre, Bangalore, for her constant
encouragement, whole hearted support and guidance which paved the way towards
successful fulfilment of our project.

We are heartily thankful to Dr. Manoj Karthik, Surgeon, Department of General


Surgery, B.G.S GIMS HOSPITAL, Kengeri, Bangalore.

We would like thank our friends and seniors for their constant support

We would like thank one and all who directly or indirectly have l ent their hand in this
venture.
ABSTRACT
ABSTRACT
Background: Post-operative pain is considered as a serious public health problem both in the
developed as well as in the developing countries. There is a need to improve post-operative pain
organization and management. Pain should be prevented and controlled to a degree that facilitates
function and quality of life. The main aim of post-operative pain management is to minimize
patient discomfort, improve mobilization and functional recovery as well as preventing the
conversion of acute pain into chronic pain.

Objective: The study was intended to assess the effectiveness of patient counselling on the
intensity of pain and analgesic use in post-operative patients, by comparing two groups as study
group and control group.

Methodology: A prospective and comparative study was conducted for a period of six months.
All the necessary data was collected and recorded in a data collection and assessment form.
Patients case notes, treatment charts and interviews of the patients and patient’s representatives
were the source of data. The collected data was analysed along with nature and extent of pain. The
study group patients were educated about non-pharmacological pain management techniques and
importance of rational analgesic use. The intensity of pain was assessed using VAS- Visual Analog
Scale and recorded in data collection form. The impact of patient counselling on patient
understanding, use of non-pharmacologic pain management techniques and analgesic use was
assessed during follow-up visit after discharge, using a questionnaire. The intensity of pain based
on pain scale readings, the use of non-pharmacologic pain management techniques and analgesic
use was compared between both study and control groups.

Results: A total of 103 patients were assessed over a period of six months. Among them, the study
group patients used more non-pharmacological therapies (44.6%) and less analgesics use (28.2%)
whereas control group patients used more analgesics (31.4%), and also observed that only 14.8%
patients did not use pain medication in control group, while 50% patients did not used pain
medication after discharge. In overall when comparing both groups on basis of level of pain it was
found that most patients in control group experienced moderate (76.5%) to severe pain (12.7%)
whereas in study group the patients experienced only mild (26.5%) to moderate pain (69.6%).

Conclusion: Our study concludes that effective patient education reduces the usage of analgesics
among postoperative patients and also enhances the usage of non-pharmacological pain
management techniques. The data collected also shows that preoperative patient education
regarding post-operative pain can reduce the intensity of the postoperative pain.

Keywords: Post-operative pain management, pharmacological pain management, Analgesics


CONTENTS
LIST OF CONTENTS

Page
Chapter Title of content number

1. Introduction
1.1 Definition 1
1.2 Types 2
1.3 Physiology 3
1.4 Emotional impact on pain 6
1.5 Drugs uswd in pain management 15
1.6 Rational and Irrational drug use 21
1.7 Non Pharmacological Therapies 23
1.8 Role of Patient Counselling 24

2. Objectives 27

3. Review of literature 29

4. Plan of work 38

5. Methodology 40

6. Results 46

7. Discussion 70

8. Conclusion 74

9. Limitations 76

10. Future direction 78

11. Reference 80

87
12. Annexure
LIST OF TABLES

Table Page
number Title no:
1. Summary for psychological process of pain 11
2. Summary for psychological models of pain 13
3. Distribution of patients based on age 46
4. Distribution patients based on gender 47
5. Distribution of patients based on diet 48
6. Distribution of patients based on social history and habits 49
7. Distribution of patients based on BMI 50
8. Distribution of patients based on education qualification 51
9. Table depicting co-morbid conditions 52
10. Distribution of patients according to surgery department 53
11. Tables for Categorization of patients based on type of 54
surgery
12. Table depicting total drug utilization data 57
13. Distribution table for analgesic use 58
14. Table depicting inpatient and outpatient analgesic use 59
15. Table comparing pain scores of study group and control 60
group
16. Table for response of questionnaire 61
LIST OF FIGURES

Figure Page
number Title no:
1. Classification of pain 3
2. Diagram for pain pathway 4
3. Flowchart for pain pathway 5
4. Emotion and the chronic pain cycle 6
5. Pain perception from a psychological way 10
6. VAS Pain measurement scale 42
7. Distribution chart of patients based on age 46
8. Distribution chart of patients based on gender 47
9. Distribution chart of patients based on diet 48
10. Distribution chart of patients based on social history and 49
habits
11. Distribution chart of patients based on BMI 50
12. Distribution chart of patients based on education qualification 51
13. chart depicting co-morbid conditions 52
14. Distribution chart of patients according to surgery department 53
15. Categorization charts of patients based on type of surgery 54
16. chart depicting total drug utilization data 57

17. Distribution chart for analgesic use 58


18. Chart depicting inpatient and outpatient analgesic use 59
19. Chart comparing pain scores of study group and control group 60

20. Charts for response of questionnaire on each item 62


LIST OF ABBRIVATIONS

Serial
number Abbreviations Full form

1. ACF Acceptance and Commitment Theory


2. ANOVA Analysis of Variance
3. ARCR Arthroscopic Rotator Cuff Repair
4. BPI Brief Pain Inventory
5. BPS Behavioural Pain Scale
6. BMI Body Mass Index
7. CABG Coronary Artery Bypass Grafting
8. CBT Cognitive Behavioural Therapy
9. CLBP Chronic Low Back Pain
10. CNS Central Nervous System
11. COX Cyclooxygenase
12. CVS Cardio Vascular System
13. DM Diabetes Mellitus
14. ESRD End Stage Renal Disease
15. FAT Fear Avoidance Model
16. GSE Generalized Self Efficacy scale
17. HIV Human Immunodeficiency Virus
18. HADS Hospital Anxiety and Depression Scale
19. HTN Hypertension
20. ICU Intensive Care Unit
21. ICMR Indian Council for Medical Research
22. LBP Low Back Pain
23. NSAIDS NonSteroidal Anti-Inflammatory Drugs
20. NRS Numerical Rating Scale
21. OTC Over The Counter
22. OBG Obstetrics and Gynaecology
23. PNS Peripheral Nervous System
24. PACU Post Anaesthesia Care Unit
25. PCA Patient Controlled Analgesia
26. PMP Pain Management Programme
27. QOL Quality of Life
28. SNRI Serotonin and Norepinephrine Reuptake Inhibitor
29. SCT Social Cognitive Theory
30. TKA Total Knee Arthroplasty
31. THR Total Hip Replacement
32. TKR Total Knee Replacement
33. VAS Visual Analog Scale
34. VRS Verbal Rating Scale
35. WHO World Health Organisation
36. WMD Weighted Mean Difference
LIST OF ANNEXURES

Serial Page
number Title no:
1a. Information consent form (English) 87
1b. Information consent form (kannada) 88
2. Data collection form 89
3. Non-pharmacological pain management 90
techniques(broacher)
4. Questionnaire for follow up patient to assess pain stage 91
INTRODUCTION
CHAPTER-1 INTRODUCTION

INTRODUCTION:

[1.1] DEFINITION:

Pain can be defined as “An unpleasant sensory and emotional experience associated with actual or
potential tissue damage or described in terms of such damage.” The nature of pain as a concept
was often confused to be a somatization disorder but according to more recent trends pain can be
considered as a multidimensional entity which includes equal involvement of CNS, cognitions and
emotions. Pain being an experience which often causes unanticipated suffering to patient, often
requires therapeutic interventions to overcome.1

The pain experienced by a patient after an invasive surgical procedure, mostly at and around the
surgical sight is called post-operative pain. The amount of post-operative pain suffered by a patient
following surgery often depends on extend of tissue damage and site of operation.2 Acute post-
operative pain is experienced by more than 80% of patients and up to 75% of these patients
reported the severity of their pain as moderate, severe or extreme.3

Therefore an effective intervention for pain relief is very important for patients who have
underwent surgery, because inadequate post-operative pain management can affect the patients
sleep, daily life, functional recovery, delay hospital discharge and thus negatively impact overall
patient wellbeing.2 Effective pain management can thus be considered an essential component in
the care of post-operative patients. Inadequate pain control apart from being inhumane, may also
result in increased morbidity and mortality of patient.3

The advantages of effective post-operative pain management include improved patient comfort,
faster patient recovery and mobilization, reduce risk of developing complications, reduce patient
hospital stay, reduce patient’s overall hospital stay duration, reduce overall medical bill and thus
improve overall patient satisfaction.4

There are a number of factors contributing to effective post-operative pain management such as
structured acute management team, proper staff training, balanced use of analgesia,
implementation of proper pain assessment tools, considering the emotional state of the patient and
giving proper patient counselling and education.4

Globally 20% - 80% of patients undergoing surgery suffer from inadequately treated pain. Post-
operative pain can be considered as a serious health problem both in developed as well as
developing nations. There is a need to improve post-operative pain organization and management.
Pain should be prevented and controlled to a degree that facilitates the functioning and quality of
life of a patient.5

Department of Pharmacy Practice, HCOPARC Page 1


CHAPTER-1 INTRODUCTION

[1.2] TYPES OF PAIN:

Pain can broadly be categorized based on onset and duration of action as:

• Acute pain can refer to the type of pain which has sudden onset and occures for a limited
duration of time. It is usually caused by tissue damage and onset can be often accompanied
by anxiety or emotional distress.
• Chronic pain refers to the type of pain which has gradual onset and lasts for a longer
duration of time. It is usually linked with long term illness such as osteoarthritis,
fibromyalgia etc and often due to tissue and nerve damage.6

Pain can also be classified based on the nature of damage and site of tissue damage as:

• Nociceptive pain is the signal of tissue irritation, impending injury, or actual injury.
Nociceptors in the affected area are activated and then transmit signals via the peripheral
nerves and the spinal chord to the brain, activated the complex spinal reflexes (withdrawal),
followed by perception cognitive affective responses, and possibly voluntary action.
Nociceptive pain is usually time limited-arthritis is a notable exception-and tends to
respond well to treatment with opiods.
• Neuropathic pain is the result of the nervous system injury or malfunction, either in the
peripheral or in the central nervous system. The pain may persist for months or years
beyond the apparent healing of any damaged tissues. Neuropathic pain is frequently
chronic, and tends to have a less robust response to treatment with opiods.
• Psychogenic Pain due to the psychological factors leading to an exaggerated or histrionic
presentation of the pain problem .
• Mixed Category Pain is caused by a complex mixture of nociceptive and neuropathic
factors. An initial nervous system dysfunction or injury may trigger the neural release of
inflammatory mediators and subsequent neurogenic inflammation. For example, migraine
headaches, myofascial pain .4

It is important to distinguish between first pain and second pain.

• First pain is sharp, and “pricking”. It localises to a well-defined part of the body surface
mediated by specific “nociceptors”.
• Second pain is dull, arching poorly localised due to stimulation of receptors that exist in
many.4

Department of Pharmacy Practice, HCOPARC Page 2


CHAPTER-1 INTRODUCTION

Figure 1:Classification of pain


(https://www.google.com/imgres?imgurl=http%3A%2F%2Fwww.denalihealthcaremi.com%2Fwp-
content%2Fuploads%2F2015%2F01%2FTypes-of-
Pain.png&imgrefurl=http%3A%2F%2Fwww.denalihealthcaremi.com%2Fcausing-
pain%2F&tbnid=PMWRHROZIFqfGM&vet=12ahUKEwjtrZP3xs7pAhVl7TgGHQNiA8sQMygCegUIARCCAg..i&docid=asahfBkAIA
rzsM&w=1154&h=677&q=classification%20of%20pain&ved=2ahUKEwjtrZP3xs7pAhVl7TgGHQNiA8sQMygCegUIARCCAg)

Postoperative pain can be divided into acute pain and chronic pain. Acute pain is experienced
immediately after surgery (up to 7 days) and pain which lasts more than 3 months after the injury
is considered to be chronic pain. Acute and chronic pain can arise from cutaneous, deep somatic
or visceral structures.4

Acute pain plays some useful positive role such as to provide a warming of tissue damage and
inducing immobilization to allow appropriate healing. But, pain has some short term negative
effects such as sleep disturbance, cardiovascular side effects, increase oxygen consumption,
impaired bowel movement, delays mobilization and promotes thromboembolism. Management of
post postoperative pain has generally been shown to be inadequate.4

[1.3]PHYSIOLOGY OF PAIN:

Nociception or acute pain perception can be due to either somatic or visceral sources.There are
free nerve endings that can stimulate an instance of pain that are found both in somatic and visceral
cells which are called nociceptors.7

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CHAPTER-1 INTRODUCTION
Nociceptors are unspecialized, free, unmyelated nerve endings that convert stimuli of pain into
nerve impulses. These impulses are transmitted to the brain in the form of chemical and electrical
signals, which can be interpreted by the brain to produce the sensation of pain.8

The stepwise process of transmission of impulse for pain is collectively described a pain
pathway.According to the pain pathway impulse transmission for pain occures through 4
processes.9 They are as follows:

1. Transduction : It is the process by which tissue damaging stimuli activate nerve endings
by the release of variouse chemical mediators to sensitize and activate action potential in
nerve ending of nociceptors.
2. Transmission:It involves the conduction and transmission of action potential along
afferent nerve fibres to the dorsal hoorn of the spinal cord. Transmission also inloves
3. Modulation: Thalamus acts as a relay station which transmits impulse to CNS through 2
ways which are :
-Direct spinothalamic pathway where thalamus recieves direct input from ascending path.
-Indirect spinoreticulothalamic pathway where thalamus get impulse indirectly from spinal
cord and brain stem by descending pathway.
4. Perception: It is the process where impulse reaches sites in the brain to enterpret the
implulse as manifestations of pain.

Figure-2: Diagram for Pain Pathway (https://images.app.goo.gl/4LpxJHFKTDsdFrru9)

Department of Pharmacy Practice, HCOPARC Page 4


CHAPTER-1 INTRODUCTION
Figure 3: PAIN PATHWAY
TRANSDUCTIONC
(flowchart) T
Damaging effect of various
mechanical, chemical and
thermal factors.

Stimulation of nociceptors.

Sensitization of nociceptors result in


release of various chemical mediators-
Bradykinins, K+, prostaglandins,
histamine, leukotrines, serotonins,

TRANSMISSION

Action potential (electric) generated by


chemical mediators is transmitted along
afferent nerve fibers to spinal cord.

Action potential ascends from dorsal


horn of spinal cord to thalamus.

Direct pathway- MODULATION Indirect pathway-medial


ventrocaudal thalamus thalamus receives indirect
receives direct input from inputs from spinal cord and
spinal neurons The thalamus acts as relay station brain stem reticular
which transmits impulse to CNS complex
Impulse is send directly to Impulse projected to
the somatosensory cortex. widespread areas of
forebrain.

Sharp well localized pain PERCEPTION Stimuli of deep somatic


that arises near body and visceral structures.
surface.

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CHAPTER-1 INTRODUCTION

[1.4] EMOTIONAL IMPACT ON PAIN:


According to the pain definition “Pain is an emotional experience and an unpleasant
sensation associated with actual or potential damage”. Thus, pain is an emotional experience and
a connection between pain and damage.17

There are some factors influencing pain experience:

Age, Gender, Spiritual beliefs, Socio-economic status, Emotional response, Supporting system,
Life before pain onset etc.18,19

Common emotional response to pain:

Anxiety, Depression, Anger, Demoralization, stigmatized feel.17, 18

According to 2004 study the patients in primary care sector have high chance to experience
anxiety and depression, causing chronic pain [individually]. So, it is important to recognize
weather these factors are predominant in one’s life. If so, then it’s important to seek help from the
primary care doctors.18

EMOTION AND THE CHRONIC PAIN CYCLE:

Pain and emotion are interrelated. Emotions may directly impact or effect the physical changes.

For example: anxiousness\angry may cause muscle tightness which may increase pain.

Depression

Pain

Anger Anxiet

Figure-4:[https:www.hss.edu> THE EMOTIONAL IMPACT OF PAIN EXPERIENCE-


HOSPITAL FOR SPECIAL SURGERY]

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CHAPTER-1 INTRODUCTION
Changes in the functioning, role [family and society], daily routines, jobs, and status and sleep
disturbances may contribute to chronic pain. These factors can cause distress, which also increases
pain.

SOCIAL FACTORS, EMOTION AND PAIN:

1. Impact of pain on identity-

The way of identify yourself to others is an important thing to show your individuality. But
having chronic pain and not knowing when the pain will reduce or go away, then it will a huge
issue and will be an embarrassing or bad impact of once individuality.

Having chronic pain may disempower and makes pain feel more pronounced. And they can’t fulfill
certain tasks and roles that were once common in their daily life. [Including gender, ethnicity and
socioeconomic status].18

For example: some who feels culturally and physically strength and ability is highly valued, may
feel the pain experience significantly, If this ability impairs, then the patient can no longer
complete the same physical task due to uncontrolled pain.

2. Impact of pain on the medical system-

According to 2005 study, patient’s report- not feeling heard by the doctors because they may
not agree with medical interpretation of pain. And patient may also believe that the pain is related
to other ailments or medical history and disagree with doctor’s opinion.18

Sometimes when the treatment does not respond with the pain, patients may feel
demoralized and they are not heard by the doctors or taken seriously. All these will increase
patients stress.

3. Impact of pain on family-

Family patterns and roles in taking care of the patients in pain plays an important role.

For example: A patient might not be able to fulfill certain tasks and communication between the
family and the patients may change based on not wanting to "bother" the affected member. This
leads to misunderstanding and puts the patients will down causing distress.

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CHAPTER-1 INTRODUCTION
Other family factors may include increased financial burden, stress, effect on sexuality and other
intimate relationships.

The goal for family members is to strike a balance between validating patient’s pain and
helping him/her to stay involved in life.18, 19

4. Communicating with your doctor-

Since the pain experience may be different on each day, it’s important to keep in reporting doctor
or a home general help to be more descriptive, accurate and increase recall.

BPI- Brief Pain Inventory may be helpful in measuring the pain at home.18

BPI measures both intensity of pain and the inference of pain.

BPI based on scale: 0-No pain [doesn’t interfere]

10-Pain as bad as you can imagine [completely interfere]

5. Maladaptive pain beliefs-

As we experience pain, we may have many different beliefs of how we should live our life
with pain that we are experiencing, this hinders our functioning level.

For example:

CATASTROPHIZING- It is a technique to overcome pain or it is a process that may link


depression and pain, which is one of the impacts to cause pain.13

The study tests shows that if depressed mood and Catastrophizing are different entities then
when one is absent the other should still contribute to poor outcome and when both are present
there should be an adverse effect. [They had additive adverse effect on pain impact].19

The negative reaction towards actual or anticipated pain experience, patients report higher
pain, poor physical functioning, more depression and stress and more ability.

• pain is sign of damage

• pain means activity should be avoided

• pain leads to disability

• pain is permanent

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CHAPTER-1 INTRODUCTION
These maladaptive beliefs can cause higher pain.

The goal is to maintaining a sense of control over life and believing in yourself and the
treatment by understanding the impact of pain and accepting your situation can reduce depression
and pain.13, 18

PSYCHOLOGY, EMOTION AND PAIN:

The experience of pain is shaped by psychological factors. To be sure, pain is a subjective


experience and is certainly related to psychological process. Individual’s reaction towards the pain
episode is shaped and influenced by previous experience.13, 17

As the psychological factors are not completely understood, the most important
psychological factors that have been incorporated into theoretical models of pain, that may explain
pain perception and treatment benefits.

The application of psychological knowledge in physical therapy might range from providing
reassurance to setting goals about the functional consequences of pain.17

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CHAPTER-1 INTRODUCTION

Pain perception from a psychological way:

Nociceptive
stimulus

E C
Attention
m o
o g
t n
i Interpretation i
o t
n i
a Copying strategy v
Boundaries: e Boundary:
l
Culture, family Learning

Behaviour
Feedback

Situation Consequence
s
+ve -ve
w

Figure 5: This flow chart helps describe pain perception from a psychological point of view.14

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CHAPTER-1 INTRODUCTION
The main factors for experience of pain are:

a. Attention

b. Cognition
c. Emotions and emotional regulation
d. Overt behavior
e. Interpretation
f. Coping strategies
g. Pain behavior

Table 1: summary for psychological process23, 24

Factor Description Possible effect on Example of treatment


pain and disability strategy
Attention Pain demands our ● Vigilance may ●Distraction techniques
attention increase pain intensity ●Interceptive exposure
● Distraction may
decrease its pain
intensity
Cognition How we think about ● Interpretations and ●Cognitive restructuring
our pain may beliefs may increase ●Behavioral experiments
influence it pain and disability designed
●Negative thoughts for example- to disconfirm
and beliefs may unrealistic expectations
increase pain and and Catastrophizing
disability
● Expectations may
influence pain and
disability
● Cognitive sets may
reduce flexibility

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Emotion and Pain often generates ● Fear may increase Cognitive-behavioral


emotion regulation negative feelings. avoidance behavior and therapy programs for
This may influence disability anxiety and depression
pain as well as ● Anxiety may increase ● Activation (to increase
cognition, attention, pain disability positive emotion)
and overt behaviors. ● Depression may ● Relaxation
increase pain disability ● Positive psychology
● Positive emotions techniques that promote
might decrease pain well-being and positive
emotions
Overt behavior What we do to cope ● Avoidance behavior ● Operant, graded activity
with our pain may increase disability training
influence our (Over activity may ● Exposure in vivo
perception. provoke pain) ●Coping strategies
● Pain behaviors training
communicate pain

MODELS OF DEVELOPMENT OF PERSISTENT PAIN PROBLEMS:

A theoretical model proposed to explain the specific ways in which psychological factors might
have bearing pain and disability over time. These conceptual models provide a pathway where by
psychological factors affect the transition from acute to persistent pain problems. 13

Psychological models of chronic pain:

a. Fear avoidance model

b. Acceptance and commitment model

c. Misdirected problem-solving model

d. Self efficacy model

e. Stress diathesis model

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Table 2: Summary for psychological models of pain, psychological process involved,
mechanism, example of treatment interventions14-16, 20-22

Theory Description Psychological Mechanism Treatment


process featured interventions
Fear A painful injury may Emotions: fear, Activity Promote physical
avoidance result in Catastrophizing worry, and avoidance and social
model and fear, which lead to depression leads to activation
avoidance of certain Attention: fear keys physical (eg: with graded
movements. attention on internal degeneration activity)
This behavior in turn stimuli and social
leads to more avoidance, Behavior: avoidance isolation
dysfunction, depression of movement
and ultimately more pain.
Acceptance Rigid beliefs (eg: that the Cognitive: flexibility Repeated Provide realistic
and pain must be cured) in beliefs, life goals, attempts to treatment goals
commitment Reduces futile attempts and commitment control pain and encourage
mode to achieve acceptance Emotions: anger and lead to client participation
and commitments. frustration frustration in decision making
Behavior:
commitment,
pursuing goals
Misdirected Normal worry about pain Emotions: worry as a Hyper Redirect problem-
problem- may tune the patient into driving force vigilance to solving efforts
solving model certain ways of solving Attention: pain pain symptoms toward
problem (eg: medical demands attention contributes to achievement of
cures). When this does Cognitions: beliefs escape pain. functional goals
not actually solve the about cause of pain
problem (eg :with Behavior: attempts
chronic pain or certain to solve problem
forms of musculoskeletal
pain), it results in more
worry and making it less
likely to solve the
problem

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Self-efficacy The belief that a person Cognitive Fluctuating Encourage self-
mode is capable of coping with interpretation: pain reduces care and self
pain is directly related to beliefs concerning perceptions of management
self-management, low controllability of control and strategies, reduce
self-efficacy, with pain mastery over dependence
feelings that the pain is Behavior: coping pain
uncontrollable cause skills
physical and
psychological
dysfunction.
Stress- Significant psychological Emotions: stress, Protective Improve stress
diathesis stress and limited coping depression, and psychosocial management skills
model makes a person feel pain anxiety factors buffer and social support
and being less prepared Behavior: coping the emotional
to deal with it. Thus, pain strategies and skills impact of pain,
is more likely to result in whereas
functional difficulties distress and
and emotional distress. emotional
dysregulation
predispose to
pain

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[1.5] DRUGS USED IN PAIN MANAGEMENT:


Patients who have undergone surgery experience a significant amount of pain associated with the
surgery. Effective pain relief therapy using drugs is therefore considered to be of utmost
importance for the wellbeing of the patients and quality of treatment after surgery.

The main goal of drug therapy in post-operative pain management is to reduce or eliminate pain
and discomfort with very minimal side effects. The various drugs used for pain relief can
collectively be called as ‘analgesics’ and such a process of pain relief is termed ‘analgesia’.
Analgesics can selectively relieve pain by interfering with central or peripheral pain mechanisms
without significantly altering consciousness. They are different from aesthetics which can partially
or completely eliminate sensation and also alter consciousness. 25

The various analgesics that can be used for treating pain can be classified as follows:

1. Opioid Analgesics
2. Non-Opioid Analgesics/NSAIDS
3. Adjuvant analgesics.

OPIOIDS ANALGESICS:

They are a group of narcotic analgesics that contain opium, or are derived from opium poppy.

Opium- A dark brown resinous substance obtained from poppy capsule.


Opioid analgesics are a very strong class of analgesic drugs used to treat moderate to severe pain.
They are also called opiates. These drugs act centrally by binding to opioid receptors. Examples
for few narcotic analgesics are as follows:

• codeine sulphate
• meperidine hcl (denerol)
• morphine hcl (dolophine)
• morphine sulphate
• propoxyphene hcl

Opioids can further be classified based on their source as:

1. Natural opium alkaloids


Eg: Morphine,
Codeine

2. Semi synthetic opiates


Eg: Dihydromorphine,
Heroin

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3. Synthetic Opioids
Eg: Pethidine
Fentanyl
Methadone
Dextropropoxyphene
Tramadol

They can also be classified based on their actions and affinity as:

1. Strong Agonist- Heroin, Morphine, Hydro morphine, Fentanyl, Alfentanil,


Hydrocodone, Oxycodone, Methadone.
2. Moderate Agonist - Codeine
3. Mixed Agonist-Antagonist- Buprenorphine, Butorphanol, and Pentazocine.

A few commonly used opioid analgesics are given as follows:

Morphine:

• The Principal alkaloid in opium and is widely used till today.


• it is a prototype

Mechanism of action:
It binds to mu-opioid receptors in the CNS and PNS. Analgesic effect is produced due to activation
of descent inhibitory pathways of CNS as well as inhibition of nociceptive afferent neurons of
PNS, which leads to reduced nociceptive transmissions and analgesic effect.

Pharmacokinetics:
• Oral absorption is unreliable, because of high and variable first pass metabolism, oral
bioavailability is1\6th and 1/4th of parenteral administered drug.
• 30%bound to plasma proteins.
• Widely distributed and concentrated in liver, spleen and higher in plasma.
• Only a negligible small fraction enters brain.
• Teratogenic- morphine can freely cross placental barrier and affect the foetus.
• Metabolized in liver by glucuronide conjugation.
• elimination is almost complete in 24 hours and morphine is noncumulative (entero-hepatic
circulation)

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Side effects:
• sedation
• mental clouding
• lethargy
• dysphoria
• vomiting
• constipation
• blurring
• respiratory depression

Codeine:
It is methyl morphine; occurs naturally in opium and it’s partly converted to morphine.

Side-effects: Constipation

Uses: Used to control diarrhoea

Heroine:
It is about 3 times more potent than morphine, more lipid soluble, enters the brain rapidly.

Eg:
Diamorphine
Diacetyl morphine

Pethidine:
It interacts with opioid receptors and its action is blocked by naloxone.

Side effects:
• Convulsions
• Dry mouth
• Blurred vision
• Tachycardia
• Tremors
• Nydriasis
• Hyper-reflexia
• Delirium

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Uses:
• Used as analgesic in pre-anaesthetic medications.
• Used to control shivering.

Dose: 50-100mg IM\SC

Methadone:

Uses:

• It has analgesic respiratory depressant, emetic, antitussive, constipation and biliary action.
• Methadone used primarily as substitution therapy in case of opioid dependence
• Occasionally employed as antitussive

Dose: 2.5-10mg IM

Tramadol:
This is a centrally acting synthetic opioid analgesic and SNRI that is structurally related to codeine
and morphine.

Side effects:
• Dizziness
• Nausea
• Sleepiness
• Dry mouth
• Sweating

Dose:
• Adult: 50-100mg oral/IM/slow IV infusion
• Child: 1-2mg/kg 4-6hourly

Uses:
• Analgesics
• Pre anaesthetic medication
• Balanced anaesthesia and surgical analgesic

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Opioid antagonists:

Eg:
• Nalorphine
• Pentazocine
• Butorphanol
• Buprenorphine

Pure opioid antagonists:

Eg:
• Naloxone
• Naltrexone
• Nalnefene

These are the drugs that are most commonly used for post-operative pain management to provide
relief from moderate to severe pain.26

NON-OPIOID ANALGESICS/NSAIDS:

Non-opioid analgesics are the OTC and prescription medicines used to alleviate pain which are
not derived from narcotic substance opium and do not interact with opioid receptors. They have
been emphasized to be the preferred, safe and effective first line therapy alternative to opioid
medicines for the treatment of mild to moderate pain.

They are generally NSAIDs which provides analgesia by inhibiting Cyclooxygenase (COX-1 and
COX-2), thereby disrupting the production of prostaglandin, an important mediator of pain and
inflammation. NSAIDs also possess antipyretic and anti-inflammatory effects, and are particularly
effective in the management of most mild to moderate cases of post-surgical pain27.

Non-opioid analgesics can be classified based on their mode of action as:

1. Non selective Cox inhibitors:


They exert their action by non-selectively binding to both Cox-1 and Cox-2 receptors.
Eg:
• Ibuprofen
• Diclofenac
• Indomethacin
• Naproxen
• Ketorolac
• Aspirin

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Uses:
• Analgesic
• Antipyretic
• Anti-inflammatory
• Antiplatelet effect

Side effects:
• Gastric and intestinal ulcers, bleeding, and perforation
• Renal function impairment
• Acute renal failure
• Deterioration of chronic renal failure
• Chronic analgesic nephropathy
• Increased risk of heart attack and stroke (with the exception of aspirin and naproxen)

2. Selective Cox-2 inhibitor:


They are those NSAIDs that exert action by selectively binding to Cox-2 receptors.

Eg-Celecoxib

Uses:
• Analgesic
• Anti-inflammatory

Side effects:
• Increased cardiovascular risk
• Renal side effects
• Deterioration of chronic renal failure
• Increase in blood pressure

3. Other non-opioid analgesics:


These agents reversibly inhibit cyclooxygenase, mainly in the CNS and are inactivated
peripherally.

Eg- Acetaminophen

Uses:
• Analgesic
• Antipyretic
Side effects:
• Hepatotoxicity
• Acute liver failure in cases of intoxication

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• Limited nephrotoxicity

ADJUVANT ANALGESICS:

Adjuvant analgesics are defined as the drugs with primary indications other than pain, but have
proven analgesic properties in some conditions of pain. Adjuvant analgesic drugs may include few
antidepressants, corticosteroids, alpha(2)-adrenergic agonists, neuroleptics, anticonvulsants etc.28

Eg:
• Amitriptyline (antidepressant)
• Gabapentine (anticonvulsant)
• Dexamethasone (corticosteroid)
• Haloperidol (neuroleptics)

[1.6] RATIONAL AND IRRATIONAL USE OF ANALGESICS:

Analgesic misuse is a worldwide problem in developed as well as developing countries. Heavy


misuse of analgesics is very commonly observed, particularly in the case of over-the-counter
(OTC) products including acetaminophen, aspirin, and other non-steroidal anti-inflammatory
drugs (NSAIDs). These pain killers are most widely used; they are the abused class of drugs
worldwide. Moreover their uses are not always without severe adverse effects. Irregular
consumption of analgesics may relieve the symptoms of pain for a time, but the actual pathology
may sometimes be more serious, complicated and even turn to fatality in some cases.29

Irrational drug prescription patterns consist of poly pharmacy, over prescribing, multi drug
prescribing, use of drugs that are not related to diagnosis and drug misuse29.Contraindications are
the restrictions put in place under certain circumstance to ensure patients are consuming the right
medication to prevent any further damage. For example, if a patient is suffering from kidney or
liver problems, they should not be consuming certain OTC analgesics such as ibuprofen. If
analgesics are ineffective patients may take more of the medication, leading to a large
consumption, which in turn can produce severe side effects such as kidney or gastrointestinal
damage, addiction or their becoming a chronic user (patients who regularly consume analgesics).30

Inappropriate use and irrational self-medication with many insufficient quantities consumption of
drugs leads to abuse. Breaking patient’s beliefs about the abuse and misuse of analgesics is a key
factor in controlling the unnecessary use of analgesics. Also understanding patient’s attitude to
analgesic usage may facilitate more effective communication between the clinician and patient, as
well as aid in the development of strategies to educate patients 29.women generally have a higher
intake of analgesics than men, and also that increasing age was associated with continuous
analgesic use. Although these finding investigated user’s analgesic habits, they did not indicate
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CHAPTER-1 INTRODUCTION
whether users were aware of the differences between analgesics or their contraindications and
adverse effects.30

The rational use of analgesics should follow the accepted three step analgesic ladder published by
WHO in 1986. The stages are as follows:

1. Non-Opioid analgesic such as aspirin or NSAIDS or acetaminophen may be given


2. A weak Opioid analgesic such as codeine or dextroproxyphene plus a non-opioid analgesic,
an adjuvant may also be given.
3. A strong opioid analgesic preferably oral morphine, a non -opioid analgesic may also be
given as an adjuvant

Indiscriminate use of parenteral analgesics varies considerably among prescribers and patients, the
reasons are the route is faster and more effective than the oral administration. Analgesic treatment
guideline states that injectable analgesics are rarely necessary; they should be reserved for patients
with acute pain.

Pharmacokinetics and clinical trials indicated that oral forms of drugs are effective as injections,
with oral medications more cost effective. Research had shown that to promote rational use of
drugs, drugs should be prescribed in their international non-proprietary names.29

Causes of irrational use of analgesics

• Prescribers-lack of education and training is one of the factors influencing irrational use of
analgesics.
• Patient-drug misinformation, this can lead to confusion and hesitancy about taking OTC
analgesics.
• Advertising play an important role in the consumer’s choice of analgesic product,
misleading advertisement, pressure and promotions from pharmaceutical companies. This
may encourage people to use drugs in situations where they may not be needed.
• Lack of adherence to analgesic treatment guidelines resulted in a significant degree of
analgesic misuse by the physicians.

The impact of irrational use of analgesics:

1. Reduction in the quality of analgesic therapy can lead to increased morbidity and mortality.
2. Increased risk of unwanted effects such as adverse drug reactions.
3. Risk of infections, due to improper use of injections.

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4. Psychosocial impacts-People believe there is a pill for every illness, at the onset of all kinds
of minor disorders; they immediately take acetaminophen, which does not require a
prescription.
5. Poly pharmacy-This involves the use of inessential combination of analgesics Combining
two or three parenteral analgesics, combining three oral analgesics or combining oral
analgesics with two parenteral at the same time.
6. The inappropriate prescribing of drugs led to unnecessary hospital admissions and visits to
physicians. This is also associated with high cost of hospital; the incidence of ESRD and
expenditures related to its treatment has been increasing consistently.

Minimizing the analgesic misuse:

The rational use of analgesic can be achieved by Regular organization of trainings and workshops
for the prescribers placing emphasis on the side effects and analgesic drug interactions Compliance
with analgesic treatment guidelines, particularly in institutional setting Regulatory strategies such
as controlling content in drug advertising, restricting prescribing to generic should be adopted.

The National Drug Policy supports the use of generic instead of brand names. Generic prescription
has got special importance for rational use of drug as regards to cost, safety and efficacy by
permitting the identification of the products by its scientific names.29

[1.7] NON-PHARMACOLOGICAL THERAPIES IN PAIN MANAGEMENT


Pain is an unpleasant feeling and emotional experience that is related to real or potential tissue
damage or a damage that is defined similarly. Pain is mostly subjective 31. From many points of
view, the pain is a common symptom intended for seeking aid 32. Although there is an increase of
knowledge and developments in technological resources regarding the pain, many patients still
experience pain 33. This situation causes for reduction in living quality and functional situation of
the patients, increase in the fatigue levels34, impairments in daily life activities, working capacity
and social interactions 35. Also, this situation will cause loss of workforce and will affect not only
the patients but also his/her family members from an economic perspective thus causing undesired
problems in psychological and social well-being status 36. All these elements have directed both
the patients and caregivers to seek out different approaches or methods to pain management 37. For
this reason, in addition to the pharmacological treatment options for pain management, today, non-
pharmacological treatment options and complementary medical attempts have started to be used
38
. It is stated that such kind of therapies can be useful in pain management 39. In a study conducted

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CHAPTER-1 INTRODUCTION
with the participation of 31.044 adults in United States, Barnes et al. (2004) determined that the
usage rate of the complementary methods for the last year has been 36% and back pain and
lumbago come first with 16.8% and neck pain comes third with 6.6% in terms of usage reasons of
the complementary methods 40. Sherman et al. (2004) have stated that 24% of the patients with
chronic lumbago used massage therapy 41. It is considered that these therapies help the standard
pharmacological treatment in pain management. While medical drugs are being used for treating
the somatic (physiological and emotional) dimension of the pain non-pharmacological therapies
aim to treat the affective, cognitive, behavioural and socio-cultural dimensions of the pain 42. These
therapies can treat the pain as adjuvant or complementary at middle level and severe pain
experiences as an adjuvant or complementary treatment 43

Non-pharmacological methods,

• Increase the individual control feeling.


• Decrease the feeling of weakness.
• Improves the activity level and functional capacity.
• Reduces stress and anxiety.
• Reduces the pain behaviour and focused pain level.
• Reduces the needed dosage of analgesic drugs thus decreasing the side effects of the
treatment 44.

[1.8] ROLE OF PATIENT COUNSELLING IN POST-OPERATIVE PAIN


MANAGEMENT:
Post-operative pain continue to be significant in healthcare, with considerable number of patients
experiencing severe pain after surgery and finding it more challenging45,hence it is essential that
patient should have an understanding of the likely aetiology of their pain ,treatment plan should
be discussed and should include a description of recommended medications ,injections and
therapeutic exercise ,proper education ensures that patient will become an active participant in
their treatment patient must be made to understand the necessary commitment to their program, as
poor compliance with treatment may be the risk factor for poor patient outcome46 .

Psychological intervention: continuous pain may lead to development of maladaptive status and
behaviour that worsen day to day life. Patients suffering pain tends to show increased vulnerability
to a variety of psychiatric illness, including depressive, anxiety and post traumatic disorders 47.in
fact, the relationship between depression and pain is likely to be bidirectional, so that the presence
of a depressive disorder has been identified as a key factor in the transition from acute to chronic
pain48. Hence patient counselling plays major role in managing pain.
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CHAPTER-1 INTRODUCTION
Similarly, there is a study named severity and impact of pain after day-surgery conducted by L
Beauregard et al. The study overviews 40% of patients reported moderate to severe pain during
the first 24hrs after hospital discharge, pain decreased gradually but was severe enough to interfere
with daily activities in substantial number of patients. More than 80% of patients (participants)
were satisfied with their pain treatment, but one patient in 4 needed to contact with a health care
provider because of pain experienced at home after discharge. Many patients reported that
instruction about pain control were either unclear as aspects. Study concluded that severity and
durations of pain after day-surgery should not be underestimated. Aggressive analgesic treatment
during the hospital stay should be provided along comprehensive patient education program 49.

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OBJECTIVES
CHAPTER-2 OBJECTIVES

OBJECTIVES:

1. To assess the the various types of surgeries carried out in the hospital.

2. To assess the role of pre-operational education in the intensity of pain after surgery.

3. Educate the patients to increase the use of non pharmacological pain management
techniques.

4. To assess the role of patient education in reducing the analgesic usage.

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REVIEW
LITERATURE
CHAPTER-3 REVIEW LITERATURE

REVIEW OF LITERATURE:

1. Peng L H et al.., conducted a prospective study to compare the improvement in patient’s


satisfaction by implementation of stratified pain management with counselling.
The study was conducted among 361 patients out of whom 187 patients received
perioperative pain risk assessment, stratified analgesia and counselling-stratified analgesia
group, while 174 patients received conventional analgesia-conventional group. The 2
groups were compared regarding post-operative pain intensity, rescue analgesia
administered and quality of recovery using Quality of recovery 40 questionnaire.
Compared to the conventional group the stratified analgesia group showed decreased pain
intensity, required lower dose of rescue analgesia (P=0.03), better scores for quality of
recovery 40 questionnaire and also lower cost-effective ratio-62 compared to conventional
group with cost effective ratio-109.The study concluded that analgesic efficacy and Patient
satisfaction was improved by the implementation of stratified analgesia and proper patient
counselling [50].

2. L Wang et al.., conducted a systematic review and meta-analysis of randomized control


trials to evaluate the efficacy of perioperative psychotherapy for patients with persistent
post-surgical pain. A total of 2220 patients eligible for review were obtained from 15 trials
found among 5 electronic databases. Evidences suggested that active pre-operative
psychotherapy significantly reduced post-surgical pain with WMD-Weighted Mean
Difference -1.06 cm on a 10 cm VAS scale with 95% confidence interval and 1.56-0.55
cm risk difference for achieving no more than mild pain (≤3cm) 14%.The study concluded
that pre-operative psychotherapy was effective for reducing persistent pain after surgery
[51]
.

3. Klaiber U et al.., conducted a PEDUCAT trial to assess the impact of pre-operative patient
education on post-operative complications and patient reported outcomes for elective
complex visceral surgery. They conducted a cluster randomized controlled PEDUCAT
trial. In a total of 244 patients (60 clusters) studied, with 138 patients included in
intervention group and 106 patients in control group. Comparing the results in intervention
and control groups respectively where as follows-pneumonia occurred in 7.4% versus *.#%
(P=0.807), Pulmonary embolism in 1.6% versus 1.0% (P=0.707), in hospital falls 0%
versus 1.9% (P=0.790). The results of the study indicated good post-operative patient
outcomes without superiority of pre-patient education, however pre-operative education
was found to be a very useful tool to educate patients and medical staff [52].

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CHAPTER-3 REVIEW LITERATURE
4. Fink C et al.., conducted a randomized controlled trial to study the impact of pre-operative
patient education on post-operative morbidity, mortality and QOL in patients scheduled for
major visceral surgery. The study was conducted on total of 204 patients (34 clusters), who
were randomized on a block basis with 1:1 allocation of subjects to group A and B based
on a computer-generated randomized list with 107 patients in each group. While group A
received pre-operative patient education group B received conventional therapy and later
after surgery the patients were analyzed using VAS scale for pain, anxiety and depression
using HADS questionnaire and QOL using SF 12 questionnaire. The study thus suggests
that pre-operative patient education could improve the overall post-operative outcome and
reduce complications [53].

5. Elizabeth C Devine conducted a meta-analysis of 191 studies on the effect of psycho-


educational care on recovery, post-surgical pain and psychological distress of adult surgical
patients. The studies conducted between 1963 and 1989 were included in the detailed
review. Analysis showed that the beneficial effects of patient education were not biased in
any relevant manner and that the positive influence of psycho-educational care provided to
adult surgical patients has been reconfirmed with larger sample studies [54].

6. Monica Ronco et al.., conducted a systematic review of studies from 2004 to 2010, to
describe the influence (effects) of pre-operative patient education on post-operative
outcomes. They conducted a detailed search from Pub Med, CINAHL and EBMR
Databases, Randomized control trials, Cochrane Central Register etc. total of 19 studies
including 3944 patients were reviewed for content of intervention and outcome related to
anxiety, patient knowledge, pain intensity and length of hospital stay. The studies
concluded that scheduling an early patient education session improved objective
knowledge as a positive outcome influenced by proper patient education [55].

7. Usman Ali M Sayed et al.., conducted a study to determine whether pre-operative


narcotics education reduced consumption of narcotics after ARCF surgery. The study
involved a total of 140 patients which were divided to 2 groups, with study group receiving
pre-operative patient education. Results of the study suggested that patients in study group
consumed significantly less narcotics than control group in a 3-month follow-up. Patients
in study group were 2.2 times more likely to discontinue narcotics (odds ratio-2.9, P=0.03),
even patients with history of narcotic use were 6.8 times more likely to discontinue
narcotics by effect of patient counselling (odds ratio-6.8, P=0.08).
The study concluded that patient education has a very positive impact on use of narcotics
by decrease in number of pills consumed and early cessation of use [56].

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CHAPTER-3 REVIEW LITERATURE
8. SooranJeon et al.., conducted a study to examine the effect of pre-operative education
using multimedia on level of pain, anxiety and depression in patients undergoing
hysterectomy surgery. The patients were divided into 2 groups and the experimental group
received pre-operative patient education. The results of study indicated that the
experimental group showed lower levels of post-operative pain in 1hr (t= -5.08, P˂0.001)
and 24hr (t=-5.20, P˂0.001).The study concluded that patient education using multimedia
prior surgery would lower the level of pain and anxiety in patients [57].

9. Heather M. Arthur et al.., conducted a randomized controlled trial to examine the effects
of multidimensional pre-operative interventions during waiting period for elective CABG
surgery. The study included 249 patients who were on a waiting list for elective CABG,
surgery scheduled after at least 10 weeks. The recruited patients were randomized into 2
groups and treatment group received interventions like exercise training twice weekly,
education training and reinforcement and monthly nurse-initiated telephone calls. The pre-
and post-operative outcomes like exercise performance, health related Quality of life,
social support, anxiety and utilization of health care services were measured. The results
indicated that treatment group had reduced length of hospital stay by at least 1 day lesser
than control group (95% CI, 0.0 to 1.0 day) and less time in intensive care unit of median-
2.1 hours (CI=1.2 to 16 hours, P=0.001). Also, during intervention period treatment group
patients had better quality of life than control group.
The study concluded that waiting period for elective procedures could be utilized
productively to enhance in-hospital and early-phase recovery, improve patient’s functional
abilities and QOL while reducing hospital stay [58].

10. U. Nilsson et al.., conducted a prospective randomized clinical trial to study and compare
the effect of music on intraoperative and post-operative pain. A total of 151 patients who
were to undergo day surgery for inguinal hernia repair or varicose vein surgery were
enrolled in the study. The participants were randomly allocated using computer generated
randomization list, into 3 groups- group 1 listened to music intra-operatively, group 2
listened to music post-operation and group 3 was control group. The pain was assessed
using numeric rating scale (0-10) and patient’s requirement for analgesia after surgery. The
nausea, anxiety and fatigue of patient was also assessed using NRS. The results of the study
indicated that intervention groups 1 and 2 which was exposed to music, reported
significantly lower pain scores in 1hr (P˂0.01) and 2hr (P˂0.01) compared to patents in
control group. The patients of intervention groups 1 and 2 also required less morphine
(1.2mg) compared to control group (2.5mg) in PACU (P≤0.05). The score for patient
anxiety were 0.2-1.8, fatigue 1.5-3.8, nausea 0.1-1.2.The study concluded that music
therapy had a beneficial effect of analgesia in patients who were exposed to music for a
short duration of time, this pain reducing effect was similar for music exposure both intra
and post-operatively [59].

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11. Subramanian BNS et al., conducted a study to compare the intensity of pain at rest and
ambulation. The study was carried out by accessing the patient’s satisfaction by different
modalities of pain management after surgery. The ASSIST (patient satisfaction survey)
was an investigator initiated, prospective multi centre survey conducted among 1046
patients from India. The survey was done in hospital at three different timings with
specially designed questionnaire, by accessing the pain scores. This shows if the presence
of Acute Pain Scale leads to better pain scores with better patient’s or caretaker’s
satisfaction scores. One-way ANOVA was used to evaluate the statistical significance
between different modalities of pain management. Paired T test was used to compare the
pain and patient’s satisfaction scores between Acute Pain Scale and Non-Acute Pain Scale
group. In a scale of 1-10 results indicate 88.4% of patients reported pain. Pain sores were
2.3±1.8 in first 24 hours followed by 1±1.5 at 72 hours. Pain relief from all pain treatment
Users reported 81.6% (Non-Acute Pain Scale group) to 77.8% (Non-Acute Pain Scale
group) group (p<0.0016) Patient satisfaction was found to be 7.9/10. The study concludes
that this investigational survey from India demonstrates the current standard of cure in
postoperative pain management remains low ‘or’ less than standard and that Acute Pain
Scale group service is not yet up to full potential [60].

12. Maria Gambatesa et al.., conducted to assess the effect of patient centred counselling on
perception of pain, reducing anxiety and depression and increase quality of life in elderly
patients with hip fracture. The study included 40 patients who were admitted to trauma
surgery ward for hip fracture. The patients were randomly divided to 2 groups case group
receiving patient centred counselling and control group receiving conventional therapy
without counselling. Measurements of scores were made using- Short form 36-item Health
Survey questionnaire, State-Trait Anxiety Inventory and Hamilton rating scale for
depression. Pain was measured using VAS every 12 hours until day 5 after surgery. The
results of the study indicated that counselling had a positive impact on quality of life of
patients, decreased anxiety and depression and lower levels of pain compared to control
group. The study concluded that effective patient counselling had a positive impact on
overall patient quality of life and reduced level of pain making pain management more
satisfying [61].

13. S. J. Dolin, J. N. Cashman, and J. M. Bland et al. (1997) had reported that the different
pain measurement tools provided comparable data. When considering a mixture of three
analgesic techniques, the overall mean (95% Cl) incidence of moderate-severe pain and of
severe pain was 29.7 (26.4-33.0) % and 10.9 (8.4-13.4) %, respectively. The overall mean
(95% Cl) incidence of poor pain relief and of fair to poor pain relief was 3.5 (2.4-4.6) %
and 19.4 (16.4-22.3) %, respectively. For IM analgesia the incidence of moderate-severe
pain was 67.2 (58.1-76.2) % and that of severe pain was 29.1 (18.8-39.4) %. For PCA, the

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CHAPTER-3 REVIEW LITERATURE
incidence of moderate-severe pain was 35.8 (31.4-40.2) % and that of severe pain was 10.4
(8.0-12.8) %. For epidural analgesia, the incidence of moderate-severe pain was 20.9 (17.8-
24.0) % and that of severe pain was 7.8 (6.1-9.5) %. These results suggest that the proposed
standards of care might be unachievable using current analgesic techniques. The data may
be useful in setting standards of care for acute pain service [62].

14. E.Y. Chan, F.M. Blyth, L. Nairn, M. Fransen et al (2013) has conducted a study on
discharged patients through questionnaire at 2 weeks after discharge. Of 171 (98%)
participants who completed the questionnaire, 88 (52%) reported that the worst pain period
occurred during the first 2 weeks at home. During the first 2 weeks at home, the average
pain was ‘severe/extreme’ for 40 (23%) participants and 92 (54%) experienced severe pain
at some time. Many participants sought further medical help for their pain. Adequate
information on analgesics and non-pharmacological methods for pain relief were reported
by only 73% and 47%, respectively. Approximately 20% had negative perceptions about
analgesic use. Higher pain severity was associated with lower satisfaction and less time
spent walking daily. Effective pain relief after hospital discharge following TKA is a
challenge. Many participants reported significant pain, sought further medical help for pain
relief and had inadequate information at discharge to effectively self-manage their
postoperative knee pain [63].

15. V. Wylde, J. Rooker, L. Halliday, A. Blom et al. (2010) has carried out a study on pain
at rest after hip and knee arthroplasty. The median acute pain scores peaked on the first
postoperative day, with 58% of TKR patients and 47% of THR patients reporting
moderate-severe pain. Preoperative pain was most frequently described as aching, stabbing
and sharp, whereas acute postoperative pain was described as aching, heavy and tender.
Night pain disturbed between 44-57% of TKR patients and 21-52% of THR patients on
postoperative nights 1-3. These findings demonstrate that acute postoperative pain at rest
after joint replacement, particularly TKR is poorly managed, although it does not reach the
severity of preoperative pain [64].

16. Steven J. Linton, William S. Shaw et al. (2011) has assessed the psychological factors in
patients with LBP is a critical first step, and successful utilizing them in treatment may be
a key to improving outcomes and preventing the development of chronic disability. A
minority of people (⁓10⁒) directly develop a persistent problem that disables them for a
long period of time. As a review of psychological interventions designed to prevent
chronicity has shown ₊ve effects when the psychological techniques are appropriately
administered[65].

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CHAPTER-3 REVIEW LITERATURE
17. Maaike Leeuw, Marielle E. J. B. Goossens, Steven J. Linton, Geert Crombez, Katja
Boersma and Johan W. S. Vlaeyen et al. (2006) had stated that the pain related fear is
associated with mis interpretations of pain, hypervigilance, avoidance behaviour as well as
with intensified pain intensity and functional disability. There is less evidence for the
existence of disuse in CLBP patients. Therefore, more research is required to establish
whether CLBP patients have lower physical activity levels and experience associated
physical consequences. But the fear-avoidance model plays a role in the development and
maintenance of problems in a subgroup of CLBP patients[66].

18. Herbert G. Masigati and Kondo S. Chilonga et al (2014) a descriptive prospective


hospital-based study, was conducted. POP and patient’s satisfaction with pain relief scores
were assessed using pain and satisfaction numerical rating scales. Pain assessment was
done at 24 hours and 48 hours after operation. Satisfaction was assessed on 48 hours post-
surgery. 124 adult patients aged 18 years and above were included. The largest percentage
of individuals had mild pain both at rest (45.2%) and during movement (44.4%). Patients
whose analgesia was administered intravenously were more likely to be satisfied with POP
management than those given IM analgesics (P₌0.028). Analgesia used in combination
significantly increased the proportion of pain free individuals 48 hours postoperative
compared to 24 hours postoperative (P= 0.003). In conclusion, the postoperative pain
management is still a challenge as nearly half of the patient had mild pain in the first 48
hours post-surgery [67].

19. MonireRahmanietal.,conducteda non-randomized controlled trial with the control group,


which was carried out on 46 patients in orthopaedic surgery units of Mousavi Hospital in
Zanjan in 2017. Study aimed to investigate the effects of family-oriented educational
intervention on postoperative pain after orthopaedic surgery. Patients were selected based
on convenience sampling and categorized into two groups of experimental (n = 23) and
control (n = 23) groups. In the experimental group, educational intervention was performed
with the attendance of the patient and his/her family members in two sessions of the
preoperative and postoperative period. The control group received routine care. The pain
intensity was measured by Visual Analog Scale (VAS) for 3 days in both control and
experimental group. Data were analysed by using Chi-square, Fisher exact test,
independent t-test, and Analysis Of Variance (ANOVA) with repeated measures and
Greenhouse-Geisser. Mean (SD) of pain intensity in the experimental and control groups
was 5.21 (1.47) vs6.74 (1.30) on the first day, 2.91 (1.20) vs 4.81 (1.32) on the second day,
and 1.75 (0.67) vs 3.38 (1.53) on the third day, respectively. Pain severity reduction was
significant in the experimental group compared to control group in every 3 days after
surgery (F = 152.30, df = 1.62, p = 0.005). The study concluded that Family-oriented
educational intervention resulted in reducing the intensity of pain and the use of narcotic
drugs after orthopaedic surgery [68].

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CHAPTER-3 REVIEW LITERATURE

20. Katherine F O DONNELL conducted an evidence based project . The project was
conducted in an outpatient general surgery service at a teaching institution for patients
undergoing same-day surgery. Intervention patients received one-on-one education on
postoperative pain management including how to take medications, managing medication
side effects, using non-pharmacologic methods, and reporting inadequate postoperative
pain control. Comparison patients received general education from multiple health care
providers, and this information may not have been consistent. A 12-month project (N = 99)
showed statistically significant results (P = .020 and P = .001, respectively) in questions
about side effects and whether the patient was encouraged to use non-pharmacologic
methods to reduce pain. The intervention group reported the effects of pain on mood (P =
.067) and use of non-pharmacologic methods (P = .052); however, these results were not
statistically significant. The study concluded that more intervention patients than
comparison patients reported medication side effects and were encouraged to use non-
pharmacologic methods for reducing postoperative pain. Intervention patients also reported
the effects of pain on mood and the use of non-pharmacologic methods more frequently
than comparison patients. Preoperative pain management education may increase patients'
knowledge in key areas of postoperative pain management to prevent negative outcomes
[69]
.

21. Eminiekol et al., conducted a study to investigate the efficiency of preoperative pain
management education and the role of analgesics administration before the onset of pain
postoperatively. The study was a prospective, randomized, and single-blind clinical trial
the same analgesia medication was used for both patient groups. But the study group,
additionally, was educated on how to deal with pain preoperatively and on the
pharmacological methods to be used after surgery. The control group did not receive
preoperative education, and analgesics were not administered to them unless they reported
pain in the postoperative period. Pain severity was assessed during the second, fourth,
eighth, 16th, 24th, and 48th hours, and marked using the Verbal Category Scale and the
Behavioural Pain Assessment Scale. The rate of pain, which was defined as sharp, stabbing,
and exhausting, was higher in the control group than in the study group, and the difference
between the two groups was statistically significant (p < .05). As the doses of analgesics
used for pain management in both groups were compared, it was determined that analgesic
consumption was lower in the study group than in the control group, and the difference
was statistically significant (p < .05). As a result, it was determined that preoperative
thoracic pain management education and analgesics administered postoperatively, before
the onset of pain, reduced the amount of analgesics used in the first postoperative 48 hour
[70]

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CHAPTER-3 REVIEW LITERATURE
22. Fredericgrondin et al., conducted a study to determine the effects of a patient and family-
centred educational intervention (accompanying family member), promoting non
pharmacologic strategies, about pain relief, anxiety, and the pain-coping strategies used.
The intervention took the family into consideration by recognizing its expertise, existence,
experience, and need for hope. Thirty-three patients took part in this quasi experimental
study, all being accompanied by a significant other (control group [CG]: n = 17;
experimental group [EG]: n = 16). The control group received conventional treatment and
the experimental group received the intervention. The results show that EG members
experienced less intense pain on postoperative days 2 (2.75 vs. 5.14; p = .001) and 4 (2.17
vs. 4.00; p = .01). EG members reported less anxiety (29.50 vs. 37.00; p = .041). EG
members used significantly fewer negative pain-coping strategies, such as ignorance and
dramatization. The results suggest that a patient and family-centred educational
intervention (accompanying family member), promoting non-pharmacologic strategies,
should be routinely used in combination with the multimodal approach. This combination
improves pain management, lowers anxiety, and facilitates the use of positive postoperative
coping strategies [71].

23. ApisadaChumkam et al., conducted a study to examine the effectiveness of cryotherapy


for reducing postoperative pain in patients who underwent exploratory laparotomy for
gynaecologic surgery. The participants were randomized into study and control groups
with simple random sampling methods. Cold packs were applied at two hours after
operation for 6 hours. The Visual Analog scale (VAS) score was recorded at two, 6, and
12 hours after operation. One hundred cases were recruited and then divided into study and
control groups equally. The mean age of both groups was 43 years. There was no difference
in demographics data of both groups. Half of the participants in both groups underwent
hysterectomies. At two hours after surgery, both groups had similar VAS scores. The study
group had a lower VAS score at 6 and 12 hours after surgery than the control group with
statistical difference. Morphine consumption within 24 hours after surgery in both the study
and control groups was 2.8±3.4 and 3.0±4.4 mg, respectively, with no statistical difference.
However, the registration time of the first morphine requirement in the study group was
statistically more prolonged than that of the control group. The lengths of hospital stay in
both groups were similar. There was no complication reported in this study, Cryotherapy
can reduce postoperative pain. In this presented study the patients who underwent
gynaecologic surgery had improved pain relief and prolonged time for the first dose of the
analgesic drug [72].

Department of Pharmacy Practice, HCOPARC Page 36


PLAN OF WORK
CHAPTER-4 PLAN OF WORK

PLAN OF WORK:
The proposed study was planned to be carried out for a period of six months.

PHASE 1

➢ Identification of need of work


➢ Literature review
➢ Obtaining consent from ethical committee

PHASE 2

➢ Design of data collection form


➢ Design of questionnaire
➢ Collection of data

PHASE 3

➢ Data analysis
➢ Conclusion and documentation

Department of Pharmacy Practice, HCOPARC Page 38


METHODOLOGY
CHAPTER-5 METHODOLOGY

METHODOLOGY:

Study Site: The study was conducted at BGS GLOBAL INSTITUTE OF MEDICAL SCIENCE
HOSPITAL, Bangalore

Study Design: The study is a prospective and comparative study.

Study Period: The study was carried out for a period of six months.

STUDY CRITERIA:

Inclusion Criteria:

• Inpatients that are undergoing surgery under general surgery, orthopaedics and gastro-
surgical departments.
• Patients who are 18 years and above of both male and female.
• Patients with their caregivers who are willing to provide their consent for the study.
Exclusion Criteria:

• Patients undergoing surgery through OBG and CVS.


• Patients who are obtaining critical care or admitted in ICU.
• Patients who are unconscious and non-cooperative.

Sources of Data:

All the relevant and necessary data will be collected from

➢ Patient case records


➢ Physician’s interview
➢ Direct interaction with patients and their care taker.

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CHAPTER-5 METHODOLOGY
Patient Informed Consent Form:

Informed Consent Form (ICF) was prepared in English as per the Indian Council for Medical
Research (ICMR) guidelines and was translated to Kannada. The form was translated to the local
language to ensure the readability of the consent form. The patients who satisfied the study criteria
were included in the study after consenting.

Design of Data Collection Form:

A suitable data collection form was designed for collecting and documenting required
information for the study. The data collection form contains the following sections for the ease
of the data collection.

• Patient demographic details: name of the patient, IP number, age, sex, ward, BMI, date
of admission, date of discharge.
• Patient’s current medical condition, past medical history, medication history, social
history and diagnosis.
• Current medications taken by the patients with its name, dose, route, Frequency,
number of days taken.
• Severity of pain of the patient measured by Visual Analog Scale (VAS) from post-
operative day one.
• Questionnaires will be filled by the patients during their follow-up.

Data Collection Tools:

The intensity of post-operative pain and the irrational use of analgesics after discharge were
analysed in the study. The intensity of pain was measured using VAS and the same was collected
via the designed data collection form (annexure: 2).The data associated with the use of post-
discharge analgesics or implementation of non-pharmacological pain management techniques by
patient to relieve pain were collected using a specially designed Questionnaire to assess analgesic
use (annexure: 4) which was designed considering the patients general condition after discharge.

Pain Scales:

The pain was assessed using Visual Analog Scale (VAS) and the data for it was collected using
data collection form (annexure: 2).

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CHAPTER-5 METHODOLOGY
Visual Analog Scale:

The Visual Analog Scale is used to measure the intensity of pain, mainly in adult population. Based
on the distribution of VAS scores, the pain intensity is described as 0 no pain, 1 to 3 – mild pain,4
to 6 – moderate pain, 7 to 9 – severe pain and 10 – worst pain imaginable.

Figure-6:https://www.google.com/url?sa=i&url=https%3A%2F%2Fwww.researchgate.net
%2Ffigure%2FVisual-analogue-scale-VAS-for-assessment-of-childrens-pain-
perception_fig1_259499877&psig=AOvVaw23-
Vzf639nsmRdwdOxlWrK&ust=1597122323518000&source=images&cd=vfe&ved=0CAM
QjB1qFwoTCMCH3rjuj-sCFQAAAAAdAAAAABA

QUESTIONNAIRE:

The data associated with the use of post- discharge analgesics or implementation of non-
pharmacological pain management techniques by patient to relieve pain, was collected using a
specially designed questionnaire (annexure:4).The questionnaire consist of 7 prepared questions
which were used to obtain follow-up data from patients after 1 week of discharge. The questions
were designed to obtain data regarding:

• Effect of the pain on daily life activities.


• Analgesic use after discharge.
• Use of non-pharmacological pain coping techniques.
• Knowledge regarding rational use of analgesics.

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CHAPTER-5 METHODOLOGY

Ethical Committee approval:

The study was approved by the Institutional Ethical Committee of HILLSIDE COLLEGE OF
PHARMACY AND RESEARCH CENTRE, Bangalore.

Study Procedure:

• The patients for this study were selected by considering inclusion and exclusion criteria
from the wards designated under General Surgery, Orthopaedics and Gastro-surgical
Departments.

• Informed consent (annexure:1) was obtained from patients who were willing to participate
in the study.

• The Patients were explained regarding title of study, nature of the study and provided
reassurance regarding concerns of safety. The patients were however blinded from the
objectives of the study to avoid any form of patient centred bias.

• The patients enrolled in the study were randomly assigned using table of computer-
generated random numbers into 2 groups namely study group which received pre-operative
patient education and control group which did not receive pre-operative education.

• Data collection forms (annexure: 2) were designed and the same was issued to collect
information such as patient demographic details, past medication history, social history,
relevant details of condition diagnosed, daily physician and nursing notes, type of surgery,
current medication/treatment chart, pre and post-surgery medication were collected from
patient case records as well as direct interaction with patient or caregiver.

• The patients assigned into the study group were given pre-operative patient education
(counselling) regarding nature of their surgical procedure, possibility of pain after surgery,
nature of pain, the use and effect of medication in treating pain, rational use of analgesics,
possible side effects and other risk factors associated with irrational use of analgesics,
various non-pharmacological techniques to cope with pain and their various benefits over
use of drugs to treat mild-moderate pain.

• The patients assigned to control group were not given any pre-operative counselling.

• All the patients were assessed from post-surgery day one.

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CHAPTER-5 METHODOLOGY
• Severity of pain was measured using visual analogue scale (VAS) where pain is numbered
between 0-10, in which 0 is no pain and 10 being worst imaginable pain and the same was
entered in data collection form (annexure: 2).

• The patient’s follow-up visit after a week from discharge was utilized to assess the patient’s
knowledge regarding rational use of analgesics and the actual number/units of optional
analgesics consumed and the use of non-pharmacological coping techniques by patients to
relieve pain after discharge, using a questionnaire (annexure:4).

• The patients, who lacked sufficient knowledge regarding rational use of analgesics and
non-pharmacological coping techniques, were re-educated regarding the same.

• Descriptive statistics including values and percentages with mean and standard deviation
were used to analyse the data.

Documentation:

The data collected from the patients were documented and the results were analysed.

Result Analysis:

The collected demographic details, Diagnosis, diet and other relevant data of patient from the
designed data collection forms were analysed. The improvement in pain scores of the patients after
providing pre-operative counselling was analysed. The usage of analgesics after discharge, among
the patients who received education regarding non-pharmacological pain management techniques
over drug use, was analysed.

Department of Pharmacy Practice, HCOPARC Page 44


RESULTS
CHAPTER-6 RESULTS

RESULTS:
A total of 122 patients were enrolled from the General Surgery, Orthopaedics and
Gastroenterology departments of BGS Global Institute of Medical Science, Bangalore. Out of 122
patients, 103 patients have completed the study while 22 of them lost follow-up and were
considered as dropout. The Demographic details of the study population are given in the following
tables:

Table 3: Distribution of patients based on Age:

AGE: Study Group: Control Group: Total


N= 56 % N=47 % (%)
18 – 27 8 14.28 2 4.25 9.7
28 – 37 14 25 5 10.63 18.4
38 – 47 16 28.57 7 14.89 22.7
48 – 57 5 8.92 22 46.80 26.2
58 and above 13 23.21 11 23.40 23.3

50 46.8
45
40
PERCENTAGE (%)

35 28.57
30 25 23.21 23.4
25
20 14.28 14.89
15 10.63 8.92 Study Group: %
10 4.25
5 Control Group: %
0
18 – 27 28 – 37 38 – 47 48 – 57 58 and
AGE above

Figure 7:Distribution of patients Based on Age

Table 3 and Figure 7 depicts distribution of patients based on age .About 103 patients were enrolled
over 6months of study period. Based on age group participants were separated into two group i.e.,
study group and control group. patients of age 18-27 years of study group were 8(14.28%)and
control group were 2(4.25%) patients,28-37 years were 14(25%)of study group and
5(10.63%)patients of control group,38-47years were 16(28.57%)of study group and 7(14.89%)
patients of control group,48-57years were5(8.92%)of study group and 22(46.80%)of control
group,58 years and above were 13(23.21%) of study group and 11(23.40%) of control group
patients were observed.

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CHAPTER-6 RESULTS

Table 4: Distribution of patients based on Gender:

GENDER: Study Group: Control Group: Total %


N=56 % N=47 %
Male 25 44.64 29 61.70 52
Female 31 55.35 18 38.29 48

Male Female

48%
52%

Figure 8:Distributin of patients based on


gender

Table 4 and Figure 8 depict the distribution of patients based on gender. Out of 103 patients 52 %
of entire population consisted of males and the remaining 48 % were females. Coming to each
group, 25(44.64%) of males and 31(55.35%) were females in study group and 29(61.70%) were
males and 18(38.29%) were females in control group.

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CHAPTER-6 RESULTS

Table 5: Distribution of patients based on Diet:

DIET: Study Group: Control Group: Total %


N=56 % N=47 %
Vegetarian 7 12.5 5 10.63 12
Non- 10 17.85 13 27.65 22
vegetarian
Mixed 39 69.64 29 61.70 66

Vegetarian Non-vegetarian Mixed

12%

22%
66%

Figure 9:distribution of patients based on


diet

Table 5 and Figure 9 depict distribution of patients based on Diet. Out of 103 patients 12 % of the
total population were vegetarians, 22 % were non-vegetarians and remaining 66% followed a
mixed diet. Coming to each group, 7(12.5%)patients were found to be vegetarians in study group
and 5(10.63%) patients in control group,10(17.85%) patients were found to be non-vegetarians in
study group whereas in control group 13(27.65%) patients,39(69.64%)patients were found to be
both vegetarians & non vegetarians in study group and 29(61.70%)in control group.

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CHAPTER-6 RESULTS
Table 6: Distribution table based on Social History and Habits:

SOCIAL Study Group: Control Group: Total %


HISTORY: N=56 % N=47 %
Smoker 8 14.28 2 4.25 10
Alcoholic 5 8.92 4 8.51 9
Smoker + 11 19.64 9 19.14 19
Alcoholic
Non-Smoker 32 57.14 32 68.08 62
+Non-Alcoholic

Smoker

10% Alcoholic
9%
Smoker +
Alcoholic
19% Non Smoker
62% +Non Alcoholic

Figure 10: Distribution of patients based


on social histort and habit

Table 6 and Figure 10 depict the distribution of patients based on social history and habits. Out of
103 patients, 8(14.28%) patients were found to be smokers in study group and 2(4.25%) in control
group,5(8.92%) patients were found to alcoholic in study group and 4(8.51%) in control
group,11(19.64%) patients were found to be both alcoholic and smoker in study group and
9(19.14%) patients in control group,32(57.14%) patients were found to be non-smoker/non-
alcoholics.

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CHAPTER-6 RESULTS

Table 7: Distribution of patients based on BMI:

BMI: Study Group: Control Group: Total %


N=56 % N=47 %
Underweight 3 5.35 1 2.12 3.88
(≤ 18.5)
Normal 31 55.35 22 46.80 51.45
(18.5 – 24.9)
Overweight 19 33.92 20 42.55 37.86
25 – 29.9)
Obese 3 5.37 4 8.51 6.79
(≥ 30)

4%
7% Underweight(≤
18.5)
Normal(18.5 –
38% 24.9)
51%
Overweight(25 –
29.9)
Obese(≥ 30)

Figure 11: Distribution of patients based


on BMI

Table 7 and Figure 11 show the distribution of patients based on BMI. Out of 103 patients BMI of
51 % of total population was Normal (18.5-24.9), 38% Overweight, 7% Obese and 4% were
Underweight. While considering each group, 3(5.35%) patients were underweight in study group
and 1(2.21%) in control group, 31(55.35%) patients were normal in study group and 22(46.80%)
patients in control group, 19(33.92%) patients were found to overweight in study group and
20(42.55%) patients in control group, 3(5.37%) were found to be obese in study group and
4(8.51%) patients in control group.

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CHAPTER-6 RESULTS
Table 8: Distribution of patients based on level of education:

EDUCATIONAL Study group Control group Total


STATUS n = 56 % n = 47 %
Primary 14 25 16 34.04 29
Education
Secondary 19 33.92 9 19.14 27
Education
Higher 11 19.64 14 29.78 24
Secondary
U.G 8 14.28 3 6.38 11
P.G 4 7.14 5 10.63 9

40 34.04 33.92
35 29.78
PERCENTAGE (%)

30 25
25 19.14 19.64
20 14.28
15 10.63
10 6.38 7.14
5
0
Primary Secondary Higher U.G P.G
education education secondary Study group %
Level Of Education Control group %

Figure 12: Distribution of patients based on education

Table 8 and Figure 12 show the distribution of patients based on level of education. Out of 103
patients Level of education of 29% of population was primary education, 27% Secondary
Education, 24% Higher Secondary, 11% UG and 9 % PG. Considering each group, 14(25%)
patients were found to have primary education in study group and 16(34.04%) patients in control
group, 19(33.92%) patients were found to have secondary education in study group and
9(19.14%) patients in control group,11(19.64%) patients were found to have higher secondary
education in study group and 14(29.78) patients in control group,8 (14.28%) patients were found
to have U.G in study group and 3(6.38%) patients in control group,4(7.14%) patients were found
to have P.G in study group whereas 5(10.63%) patients in control group were observed.

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CHAPTER-6 RESULTS
Table 9: Depicting co-morbid conditions:

CO-MORBID Study group Control N=103


CONDITIONS group
N % n %
Diabetes 21 37.5 18 38.29 39(37.86)
Hypertension 6 10.71 5 10.63 11(10.67)
Thyroid dysfunction 3 5.35 2 4.25 5(4.85)
Dyslipidaemia 4 7.14 8 17.02 12(11.65)
Diabetes+ Hypertension 4 7.14 2 4.25 6(5.82)
Diabetes+ Dyslipidaemia 1 1.78 1 2.12 2(1.94)
Thyroid dysfunction+ 1 1.78 0 0 1(0.97)
Dyslipidaemia
No co-morbidities 16 28.57 11 23.40 27(26.21)

No co-morbidities 23.4
28.57
Thyroid dysfunction+ Dyslipidemia 0
CO-MORBID CONDITIONS

1.78
Diabetes+ Dyslipidaemia 2.12
1.78
Control group %
Diabetes+ Hypertension 4.25
7.14 Study group %
Dyslipidaemia 17.02
7.14
Thyroid dysfunction 4.25
5.35
Hypertension 10.63
10.71
Diabetes 38.29
37.5
0 20 40 60
PERCENTAGE (%)

Figire 13: Depiciting co-morbid conditions

Table 9 and Figure 13 depict co-morbid conditions. Out of 103 patients, those without any co-
morbid conditions were found to be 27(26.21%), diabetes patients were found to be 39(37.86%),
Hypertension patients were found to be 11(10.67%), patients with thyroid dysfunction were
found to be 5(4.85%), patients with Dyslipidaemia were found to be 12(11.65%),Diabetes+
Hypertension patients were found to be 6(5.82%), Diabetes+ Dyslipidaemia patients were found
to be 2(1.94%) and patients with thyroid dysfunction+ Dyslipidaemia were found to be
1(0.97%).

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CHAPTER-6 RESULTS

Table10: Distribution of patients according to surgical department:

SURGICAL Study group Control group


DEPARTMENT n =56 % n =47 %
Orthopaedics 8 14.28 10 21.27

Gastro-surgical 21 37.5 14 29.78

General surgery 27 48.21 23 48.93

60
48.21 48.93
50
PERCENTAGE (%)

40 37.5
29.78
30 Study group %
21.27
20 Control group %
14.28
10

0
Orthopedic Gastro-surgical General surgery
SURGICAL DEPARTMENTS

Figure 14: Distribution patients according to surgery departmen

Table 10 and Figure 14 depict the distribution of patients according to surgical Departments. Out
of 103 patients 8(14.28%) patients are from orthopaedics department study group and
10(21.27%) patients from control group, gastro-surgical 21(37.5%) patients from study group
and 16(34.04%) patients from control group, general surgery 27(48.21%) patients from study
group and 23(48.93%) patients from control group were observed.

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CHAPTER-6 RESULTS
Table 11: Categorization of patients based on type of surgery:

GENERAL Study group Control group


SURGERY n=27 % n=23 %
DEPARTMENT
Cataract surgery 2 7.40 6 26.08

Cholecystectomy 7 25.92 3 13.04

Mastectomy 3 11.11 1 4.34

Prostatectomy 1 3.70 1 4.34

Hernia 5 18.51 3 13.04

Amputation 9 33.33 9 39.1

45 39.1
PERCENTAGE (%)

40 33.33
35
30 26.08 25.92
25 18.51
20 13.04 11.11 13.04
15 7.4
10 4.34 3.74.34
5
0

Study group
%
Control group
%

Figure 15.1: categorization of patients in general surgery Department.

Table 11 and Figure 15.1 shows categorisation of patients based on type of surgery in general
surgery department. Out of 103 patients 2(3.5%) patients have undergone cataract surgery in study
group and 5(10.6%) patients from control group,7(12.5%) patients have undergone
cholecystectomy in study group and 3(6.3%) patients from control group, 3(5.3%) patients are
undergone mastectomy in study group and 1(2.12%) patient from control group , 1(1.7%) patient
have undergone prostatectomy in study group and 1(2.12%) patient from control group,5(8.9%)
patients have undergone hernia surgery in study group and 3(6.3%) patients from control
group,9(16%) patients have undergone amputation in study group and 10(21.2%) in control group
were observed.

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CHAPTER-6 RESULTS

ORTHOPAEDIC Study group Control group


DEPARTMENT n=8 % n=10 %
Knee replacement 2 25 2 20
Shoulder 1 12.5 2 20
replacement
Joint fusion 3 37.5 5 50
Spine surgery 2 25 1 10

60 50
PERCENTAGE (%)

50
37.5 Study group %
40
30 25 25
20 20 Control group %
20 12.5 10
10
0

Figure 15.2: categorization of patients in orthopaedics surgery


department.

Table 11 and Figure 15.2 shows categorisation of patients based on type of surgery in orthopaedics
surgery department. Out of 103 patients 18 patients have undergone surgery in orthopaedics
department. 2(3.5%) patients have undergone knee replacement in study group and 2(4.2%)
patients in control group, shoulder replacement 1(1.7%) patient in study group and 2(4.2%)
patients in control group, joint fusion 3(5.3%) patients in study group and 5(10.6) patients in
control group, spine surgery 2(3.5%) patients in study group and 1(2.1%) patient in control group
were observed.

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CHAPTER-6 RESULTS

GASTROENTEROLOGY Study group Control


DEPARTMENT group
n=21 % n=14 %
Appendectomy 13 61.90 8 57.14
Gastrointestinal tumour 4 19.04 3 21.42
Haemorrhoidectomy 3 14.28 2 14.28
Hiatus hernia 1 4.7 1 7.14

70 61.9
57.14
60
PERCENTAGE (%)

50
40
30 19.04 21.42
20 14.28 14.28
10 4.7 7.14
0

Study group %
Control group %

TYPE OF SURGERY

Figure 15.3: categorizing patients based on gastroenterology


department

Table 11 and Figure 15.3 shows categorisation of patients based on type of surgery in
gastroenterology department. Out of 103 patients 35 patients have undergone surgery in
gastroenterology department.13(23.2%) patients have undergone appendectomy in study group
and 8(57.1%) patients in control group, gastrointestinal tumour 4(7.1%) patients in study group
and 3(21.42%) patients in control group, haemorrhoidectomy 3(5.3%) patients in study group and
2(14.28%) patients in control group, Hiatus hernia 1(1.7%) patient in study group and 1(7.14%)
in control group were observed.

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CHAPTER-6 RESULTS

Table 12: Depicting Total Drug Utilization Data:

MEDICATION CLASS Study group Control N=406


group
N=209 N=197
Analgesics 59 28.22 62 31.47 121(29.80)
Anti-Diabetic 46 22.00 40 20.30 86(21.18)
Anti-Hypertensive 15 7.17 14 7.10 29(7.14)
Anti-Thyroid 9 4.30 5 2.53 14(3.44)
Anti-Dyslipidemic 11 5.26 20 10.15 31 ( 7.63)
Antibiotics 60 28.70 50 25.38 110(27.09)
Others 9 4.30 6 3.04 15 (3.69)

Others 3.04
4.3
25.38
Antibiotics
MEDICATION CLASS

28.7
Anti-Dyslipidaemic 10.15
5.26
Anti-Thyroid 2.53 Control group %
4.3
Anti-Hypertensive 7.1 Study Group %
7.17
20.3
Anti-Diabetic
22
31.47
Analgesics 28.22
0 10 20 30 40
PERCENTAGE (%)

Figure 16: Depiciting total drug utilization

Table 12 and Figure 16 depict total drug utilization. Out of 406 drugs totally used, Analgesics
121(29.80%), Anti-Diabetics 86(21.18%), Anti-Hypertensive 34(8.37%), Anti-Thyroid
14(3.44%), Anti-Dyslipidaemia 38(9.35%), Antibiotics 113(27.83%).

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CHAPTER-6 RESULTS

Table 13: Distribution table for analgesic use:

DRUG CLASS Study group Control group


n=56 % n=47 %
Non-Opioids 35 62.5 36 76.59
Opioids 19 33.92 11 23.40

Adjuvant therapy 2 3.57 0 0

90
76.59
80
PERCENTAGE (%)

70 62.5
60
50 Study group %
40 33.92
30 23.4 Control group %
20
10 3.57 0
0
Non-Opioids Opioids Adjuvant
therapy
ANALGESIC MEDICATION CLASS

Figure 17: Distribution chart for analgesic use

Table 13 and Figure 17 depict analgesic use for both groups. Out of 103 patients 35(62.5%)
patients used analgesics in study group and 36(76.59%) patients in control group, Opioids
19(33.92) patients in study group and 11(23.40%) patients in control group, adjuvant therapy
2(3.57%) patients in study group and 0 patients in control group were observed.

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CHAPTER-6 RESULTS
Table 14: Distribution table for in-patient and out-patient analgesic use:

DRUG CLASS In-patient Out-patient


n=103 % n=103 %
Non-Opioids 71 68.93 83 80.58
Opioids 30 29.12 18 17.47

Adjuvant therapy 2 1.94 2 1.94

Figure 18: Distribution chart for inpatient and outpatient analgesic use

In-patient analgesic Out-patient analgesic


use: use:
2% 2%
Non-Opioids
17%
29%
Opioids
69%
81%
Adjuvant
therapy

Table 14 and Figure 18 depict data on in-patient and out-patient analgesic use. Out of 103 in-
patients 71(68.93%) patients use non-Opioids, 30(29.12%) patients used Opioids, and 2 (1.94%)
patients used adjuvant therapy in study group. Out of 103 out-patients 83(80.58%) patients used
non-Opioids, 18(17.47%) patients used Opioids and 2(1.94%) patients used adjuvant therapy in
control group were observed.

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CHAPTER-6 RESULTS
Table 15: Comparing pain scores of study group and control group:

PAIN SCORE: Study group Control group


n=56 % n=47 %
No Pain (0) 0 0 0 0
Mild Pain (1–3) 15 26.7 5 10.63

Moderate Pain (4–6) 39 69.6 36 76.59

Severe Pain (7-9) 2 3.57 6 12.76

Worst Possible Pain 0 0 0 0


(10)

0
Worst Possible Pain (10) 0
PAIN SCORE RANGE:

12.76
Severe Pain(7-9) 3.57
76.59
Moderate Pain(4–6) 69.6
10.63
Mild Pain(1–3) 26.7
0 Control group %
No Pain(0) 0
Study group %
0 50 100
PERCENTAGE %
Figure 19: chart comparing pain scores of
both groups

Table 15 and Figure 19 shows data on comparison of pain scores for both groups. Out of 47
patients, 12.76% patients experienced severe pain(7-9), 76.59% experienced moderate pain(4-6)
and 10.63% mild pain(1-3) incontrol group. Out of 56 patients, 3.57% experienced severe pain(7-
9), 69.6% experienced moderate pain(4-6) and 26.7% mild pain(1-3).

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CHAPTER-6 RESULTS

Table 16: Table for Response of Questionnaire:

QUESTION OPTIONS STUDY CONTROL


GROUP GROUP
ITEM 1: What was the No pain 7.14 4.25
frequency of pain after Very rarely 16.07 25.53
discharge? Occasionally 37.5 31.91
Frequently 32.14 25.53
Continuous 7.14 12.76

ITEM 2: Did the pain No restriction 5.35 8.51


seem to restrict any Mild restriction 50 25.53
Daily Life Activities? Moderate restriction 32.14 38.29
Severe restriction 10.71 17.02
Very severe 1..78 10.63
restrictions

ITEM 3: How did you No pain 7.14 4.25


attempt to relieve your Consulted physician 3.57 10.63
pain? Tolerated pain 5.35 4.25
Used Medication 39.28 70.21
Used Non- 44.64 10.63
Pharmacological
techniques

ITEM 4: Do you feel Strongly Agree 25 21.27


that increased use of Agree 46.42 25.53
analgesics can be Neutral 17.85 36.17
harmful?
Disagree 7.14 10.63
Strongly Disagree 3.57 6.38

ITEM 5: Do you feel Strongly Agree 23.2 17.02


that the use of non- Agree 35.71 23.40
pharmacological Neutral 28.57 31.91
techniques for pain
Disagree 10.71 19.14
management is more
suitable (appropriate) Strongly Disagree 1.78 8.57
than drugs after
discharge?

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CHAPTER-6 RESULTS

ITEM 6: How many None 50 14.89


doses of discharge Single dose 28.57 23.40
medication did you Multiple doses/ Half 12.5 40.42
utilize to relieve pain? the number of
prescribed doses
Entire number doses 8.92 17.02
prescribed
More than prescribed 0 4.25
number of doses

ITEM 7: Do you believe Strongly Agree 57.14 25.53


that there are long term Agree 26.78 42.55
effects to chronic use of Neutral 8.92 19.14
pain medication?
Disagree 7.14 8.51
Strongly Disagree 0 4.25

ITEM 1: -What was the frequency of pain after discharge?

Continuous 12.76
7.14 CONTROL GROUP
25.53
Frequently 32.14 STUDY GROUP
OPTIONS

31.91
Occasionally 37.5
Very rarely 25.53
16.07
4.25
No pain 7.14

0 20 40
PERCENTAGE %
Figure 20: ITEM 1

From the total of 103 patients the episode of pain in study group was found to be continuous
(7.14%), frequently (32.14%), occasionally (37.5%), very rarely (16.07%) and no pain (7.14%).
In control group episodes of pain were found to be continuous (12.76%), frequently (25.53%),
occasionally (31.91%), very rarely (25.53%) and no pain (4.25%).

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CHAPTER-6 RESULTS

ITEM 2:-Did the pain seem to restrict any Daily Life Activities?

Very severe restrictions 10.63


1.78
Control Group
Severe restriction 17.02
10.71
Study Group
OPTION

Moderate restriction 38.29


32.14

Mild restriction 25.53


50

No restriction 8.51
5.35

0 20 40 60
PERCENTAGE %

Figure 20.2: ITEM 2

From a total of 56 patients, 1.78% experienced very severe restrictions, 10.71% experienced severe
restrictions, 32.14% experienced moderate restrictions, and 50 % experienced mild restrictions and
5.35% with no restrictions in the study group. From a total of 47 patients 10.63% experienced very
severe restrictions, 17.02% experienced severe restrictions, 38.29% experienced moderate
restrictions, 25.53% experienced mild restrictions and 8.51% experienced no restrictions in control
group.

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CHAPTER-6 RESULTS

ITEM 3:-How did you attempt to relieve your pain?

10.63
Non-Pharmacological… 44.64
Control Group
70.21
Used Medication 39.28
Study Group
OPTION

4.25
Tolerated pain 5.35
10.63
Consulted physician 3.57
4.25
No pain 7.14

0 50 100

PERCENTAGE % Figure 20.3: ITEM 3

From a total of 56 patients, 44.6% used non-pharmacological techniques, 39.28% used pain
medication, 5.35% tolerated pain, and 3.57% consulted physician and 7.14% with no pain in the
study group. From a total of 47 patients 10.63% used non-pharmacological techniques, 70.21%
used pain medication, 4.25% tolerated pain, 10.63% consulted physician and 4.25% with no pain
in control group.

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CHAPTER-6 RESULTS

ITEM 4:-Do you feel that increased use of analgesics can be harmful?

Strongly Disagree 6.38


3.57 Control Group

Disagree 10.63 Study Group


7.14
OPTION

Neutral 36.17
17.85
25.53
Agree 46.42
21.27
Strongly Agree 25

0 20 40 60

PERCENTAGE %
Figure 20.4: ITEM 4

From a total of 56 patients, 3.57% strongly agree, 7.14% disagree, 17.85% were neutral, 46.42%
agree and 25% strongly agree in the study group. From a total of 47 patients 6.38% strongly
disagree, 10.63% disagree, 36.17% were neutral, 25.53% agree and 21.27% strongly agree in
control group.

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CHAPTER-6 RESULTS

ITEM 5:- Do you feel that the use of non-pharmacological techniques for pain management is
more suitable (appropriate) than drugs after discharge?

Strongly Disagree 8.57


1.78
Control Group
Disagree 19.14
10.71 Study Group
OPTIONS

Neutral 31.91
28.57
23.4
Agree 35.71
17.02
Strongly Agree 23.2

0 20 40
PERCENTAGE %
Figure 20.5: ITEM 5

From a total of 56 patients, 1.78% strongly disagree, 10.71% disagree, 28.57% were neutral,
35.71% agree and 23.2% strongly agree in the study group. From a total of 47 patients 8.57%
strongly disagree, 19.14% disagree, 31.91% were neutral, 23.4% agree and 17.02% strongly agree
in control group.

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CHAPTER-6 RESULTS

ITEM 6:-How many doses of discharge medication did you utilize to relieve pain?

4.25 Control Group


More than prescribed… 0
Study Group
17.02
Entire number doses… 8.92
OPTIONS

40.42
Multiple doses/ Half the… 12.5
23.4
Single dose 28.57
14.89
None 50

0 50
PERCENTAGE %
Figure 20.6: ITEM 6

From a total of 56 patients, 0% used more than prescribed doses, 8.92% used entire number of
doses, 12.5% used multiple/half the number of prescribed doses, 28.57% used only a single dose
and 50% used none in the study group. From a total of 47 patients 4.25% used more than prescribed
doses, 17.02% used entire number of doses, 40.42% used multiple/half the number of prescribed
doses, 23.4% used only a single dose and 14.89% used none in the control group.

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CHAPTER-6 RESULTS

ITEM 7: - Do you believe that there are long term effects to chronic use of pain medication?

Control Group
Strongly Disagree 4.25
0
Study Group
8.51
Disagree 7.14
OPTIONS

Neutral 19.14
8.92

Agree 42.55
26.78
25.53
Strongly Agree 57.14

0 20 40 60

PERCENTAGE % Figure 20.7: ITEM 7

From a total of 56 patients, 0% strongly disagrees, 7.14% disagree, 8.92% were neutral, 26.78%
agree and 57.14% strongly agree in the study group. From a total of 47 patients 4.25% strongly
disagree, 8.51% disagree, 19.14% were neutral, 42.55% agree and 25.53% strongly agree in
control group.

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DISCUSSION
CHAPTER-7 DISCUSSION

DISCUSSION:

The study has been conducted in the patients who went through surgery under gastroenterology,
orthopaedic and general surgery departments respectively. Among them 103 cases were assessed
and compared for pain management using various pharmacological techniques, a day after the
surgery during the six months study period.
Out of 103 study population 56 patients were selected as study group who receives a non-
pharmacological patient education and remaining 47 patients were selected as control group who
will not receive any kind of patient counselling regarding non-pharmacological pain management.
And the study population included are patients above 18 years of age.
In our study we had used the standard VAS scale to assess the pain intensity among both the
groups.

• Out of 56 patients in study group and 47 patients in control group, it is observed that the
age group between 38-47 (28.5%)followed by 28-37 (25%) years of study group and the
age group between 48-57 (46.8%) followed by 58 and above (23.4%) years of control
group were more prone to experience post-operative pain. However, among the overall
study population of 103, it is observed that the high percentage (26.3%) of patients prone
to experience post-operative pain were age groups 48-57 (26.2%) followed by 58 and
above years and seen less in age group between 18-27 years (9.7%).Michal Borys et al., [73]
support the statement.

• As per the present study we observed that the Female patients (55.35%) were more in study
group and Male patients (61.7%) were more in control group. But the total population of
103 shows more of male patients (52%) under post-operative pain management, who had
a social history of alcoholism smoking and also an unorganised diet habit. A study done
by Gupta A et al., [4] also shows that males are more affected by social habits.

• In the study out of 103 patients, both in the study group (56) and control group (47) patients
using mixed diet were high in percentage (69.6% and 61.7% respectively) followed by
non-vegetarians (22%). And it also showed a risk of infection and increase pain scale in
patients with social history and habits. K D Tripathi et al., [26] briefs the same.

• From total study population of 103 patients divided into two groups. Study group 56
patients and control group 47 patients. In study group we observed that BMI of the total
study population results were found 5.35% of the total population were underweight,
55.35% population were having normal BMI, 33.92% of patients were found to be

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CHAPTER-7 DISCUSSION
overweight and 5.37% of patients were obese. Similarly, 46.80% of the total control group
patients were having normal BMI, 42.55% of patients were overweight, 8.5% of the
patients were obese and 2.12% of patients were underweight. So, majority of the total
participants in the study were having normal BMI.

• Total of 103 patients were involved in the study. In study group we observed the education
status of the patient. Total of 56 patients were involved in the study group.25% of the study
population were having primary education, 33.92% of patients having secondary
education, 19.64% of patients with higher secondary education, 14.28% of the patients
were U.G and 7.14% of patients were P.G. Similarly, in control group 47 patients were
involved. Among them 34.04% were having primary education, 19.14% of the patients
with secondary education, 29.78% of patients with higher secondary education ,6.28% of
patients with U.G and 10.63 patients with P.G.So, majority of the total population in study
group are having secondary education as their educational status. Similarly, in control
group majority of patients having primary education are their educational status.

• Post-operative pain management was carried out in orthopaedic, gastroenterology and


general surgery departments. Among these departments general surgery reported majority
of cases i.e. 48.21% in study group and 48.93% in control group. In gastroenterology
department 37.5% patients were involved in study group and 29.78% patients in control
group. In orthopaedic department 14.28% were involved in study group and 21.27% in
control group.

• In general surgery department numbers of amputation cases were 16% in study group
population and 39.1% in control group, significantly more when compared to other
procedures in general surgery department.

• In this study 3.5% of patient undergone cataract surgery in study group similarly 26.08%
patients in control group. Vashist P et al., supports the study by concluding that India has
a high prevalence of age-related cataract that requires surgical intervention [74].

• In gastroenterology department number of appendectomy cases were 23.2% of study group


population and 57.14% in control group which is significantly more when compared to
other surgery in gastroenterology department, 7.1% of patient’s undergone gastrointestinal
tumour in study group and 21.42% of patients in control group, Haemorrhoidectomy 5.3%
in study group and 14.28% in control group.
• From the total study population of 103 surgical patients, 26 % was found to have no other
co-morbid conditions and the remaining74% of population possessed various co-

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CHAPTER-7 DISCUSSION
morbidities. The most commonly observed co-morbid condition in this population was
found to be Diabetes (38%) followed by Hypertension and Dyslipidaemia (11%).
Parthasarathi S et al., also concludes the same [75].

• For 103 surgical patients, a total of 406 drugs were used, according to data collected up to
post-operative day 2. Majority of drugs utilized were analgesics (29.830 %) to manage
pain and Antibiotics (27%). The results were similar to study conducted by Arshad M et
al.,[78] There was observed to be an increased use of analgesics by control group (31.47 %)
than study group (28.22 %) which received pre-operative patient counselling. The results
are similar to Armaenazgaia et al., [76].

• The most commonly prescribed class of analgesics overall was found to be non-opioid
analgesics and the use of non-opioid analgesics was more in control group (76.59%) than
study group (62.5%). It was also found that use of opioid analgesics was seen more among
inpatients (29.12%) than outpatients (17.47%) and the use of non-opioid analgesics was
more in outpatients (80.58%) than inpatients (68.93%).

• While comparing both groups on basis of level of pain it was found that most patients in
control group experienced moderate (76.59%) to severe pain (12.76%) while in study
group the patient’s experienced only mild (26.5%) to moderate pain (69.6%).the results
were similar to Sharif F et al.,[77].

• According to the data collected from questionnaire during follow-up after discharge it was
found that majority patients in study group (44.64%) utilized non-pharmacological
techniques to control pain whereas most patients from control group (70.21%) used
medication to control pain. From post-discharge follow-up it was seen that patients in study
group had better understanding regarding analgesic drug use and non-pharmacological
techniques, when compared to control group patients. It was also seen that only 14.89%
patients did not use pain medication after discharge in control group while up-to 50% of
patients did not use any pain medication after discharge in the study group. The results data
is thus contradicting to that of study conducted by Callaghan P et al,.[78].

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CONCLUSION
CHAPTER-8 CONCLUSION

CONCLUSION:
The present study was focused on identifying, documenting and analysing the effectiveness
of patient education in non-pharmacological techniques to relieve post-operative pain. Total of
103 patients were involved in the study which were divided into study group 56 and control group
47 patients. Study group educated with both pharmacological and non-pharmacological therapy,
while control group received standard pharmacological therapy. When comparing both the groups
on basis of pain it was found that most in control group experienced moderate to severe pain.
Whereas in study group the patients experienced only mild to moderate pain on post-operative day
one.

Our study data shows that the study group has experienced less intensive pain than control group
[mild to moderate pain] i.e. 26.7% and 69.6% respectively. So that we conclude that preoperative
education reduce the intensity of post-operative pain.

According to the data collected from the questionnaire during follow-up after discharge it was
found that majority of patients in study group (44.64%) utilized non pharmacological techniques
to control pain whereas most patients from control group (70.21%) used medications to control
pain.

Hence from this research study we conclude that effective patient education in pain management
and analgesic usage has a significant role in improving the quality of patient’s life.

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LIMITATIONS
CHAPTER-9 LIMITATIONS

LIMITATIONS:

❖ The period of study was six months which was very limited to carry out the
comparison in wider aspects.
❖ Study only done in respective departments, so it needs to include the other
surgical departments too.
❖ Could not reach the estimated study population due to patients who lost
follow-up and considered them as dropouts.

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FUTURE
DIRECTIONS
CHAPTER-10 FUTURE DIRECTIONS

FUTURE DIRECTIONS OF THE STUDY

❖ Increase sample size and study period can give more focused result.

❖ Can include Obstetrics, Gynaecology and CVS surgery.

❖ Study including an acupuncturist specialist may reduce the use of pain relief
medications.

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REFERENCE
CHAPTER-11 REFERENCE

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4. Gupta A, Kaur K, Sharma S, Goyal S, Arora S, Murthy RS. Clinical aspects of acute post-
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and Public Policy Perspectives. Washington (DC): National Academies Press (US); 1987.
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9. Lorenzo Crumbie , Gate Theory and Pain Pathway , KEN HUB
10. Yam MF, Loh YC, Tan CS, Khadijah Adam S, Abdul Manan N, Basir R. General Pathways
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11. Dubin AE, Patapoutian A. Nociceptors: the sensors of the pain pathway. J Clin Invest.
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CHAPTER-11 REFERENCE
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ANNEXURE
CHAPTER-12 ANNEXURE

ANNEXURE 1(a):

INFORMED CONSENT FORM:

1. I have been informed that this study is on, “Assessment of Post-Operative Pain
Management with pre-patient education in surgery department at a tertiary care hospital”.
2. I understand that my participation in the study may not have a direct benefit to me.
3. I understand that the information produced by this study will become part of institutional
record and remain confidential by the said institute.
4. I understand that my participation is voluntary, and I may refuse to participate or may
withdraw my consent for participation at any time of the study.

I agree not to restrict the use of any data or results that arise from this study provided such
a use is only for scientific purpose.

I confirm that ____________ (chief researcher) has explained to me the purpose of research
and the study procedure in my language. Therefore, I agree to give consent to do the study
in this area and participate in this research.

Participant’s signature: Date:

I have explained to _________________(subject) the purpose of this research, to the best


of my ability.

Investigator’s signature: Date:

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CHAPTER-12 ANNEXURE

ANEXXURE 1(b)

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CHAPTER-12 ANNEXURE

ANNEXURE 2:
PATIENT DATA COLLECTION FORM

DEMOGRAPHICS:
Name: Age: Sex: I.P No.: D.O.A: D.O.D:
Department: BMI: Level Of Education:
DIAGNOSIS: ALLERGY:

DIET: SOCIAL HISTORY:

MEDICAL HISTORY/C0-MORBIDITIES:
TYPE OF SURGERY:
PAIN INTENSITY (Pain scale value): LENGH OF HOSPITAL STAY:

SNo: MEDICATION NAME: DOSE: ROA: FREQUENCY: DURATIN OF TREATMENT:


(Class) 1 2 3 4 5

DISCHARGE MEDICATION (Optional analgesic):

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CHAPTER-12 ANNEXURE

ANNEXURE 3:
NON-PHARMACOLOGICAL PAIN MANAGEMENT TECHNIQUES:

GOAL: THERAPIES:
• TO MINIMIZE PAIN 1.SELF CARE-
• KEEP YOU MOVING • COLD THERAPY-ice pack relieves pain and
• HELP YOU HEAL
reduces inflammation and swelling. For about 15-
• SAFE AND EFFECTIVE PAIN CONTROL
20 minutes.
• HEAT THERAPY-heat reduces muscle pain and
NON-PHARMACOLOGICAL THERAPY
stiffness. For about 20-30 minutes.
+
Note: too much heat can increase swelling and
MEDICATION THERAPY
inflammation.

EFFECTIVE PAIN MANAGEMENT 2.EXERCISE AND MOVEMENT-mild regular exercise


and physical activity can relieve pain based on patient’s
physical status after recommended period of rest post-
TO ENHANCE RECOVERY AFTER surgery.
SURGERY BY: Note: vigorous intensity exercises may cause surgical site
• Improve patient understanding about his disturbances
pain and its management 3.POSITIONING-position changes prevent the
• Provide techniques which help patient to subsequent development of pain and reduce the acute pain.
cope with the pain to certain extend. It is one of the most common post-operative non-
• Provide relevant dietary advice to pharmacological pain management method.
improve patient prognosis. 4.DIETARY SOURCE-relevant dietary advice can be
provided based on appropriate nutrition to support the
healing process.

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CHAPTER-12 ANNEXURE

ANNEXURE 4:

QUESTIONNAIRE:

1. What was the Frequency of pain episodes after discharge?


a) No pain
b) Very rarely
c) Occasionally
d) Frequently
e) Continuous

2. Did the pain seem to restrict any daily life activities?


a) No restriction
b) Mild restriction
c) Moderate restriction
d) Severe restriction
e) Very severe restrictions

3. How did you attempt to relieve your pain?


a) Tolerated pain
b) Consulted physician
c) Tried home remedies
d) Used Medication
e) Used Non-Pharmacological techniques

4. Do you feel that increased use of analgesics can be harmful?


a) Strongly Agree
b) Agree
c) Neutral
d) Disagree
e) Strongly Disagree

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CHAPTER-12 ANNEXURE
5. Do you feel that the use of non-pharmacological techniques for pain management is more
suitable (appropriate) than drugs after discharge?
a) Strongly Agree
b) Agree
c) Neutral
d) Disagree
e) Strongly Agree

6. How many doses of discharge medication did you utilize to relieve pain?
a) None
b) Single dose
c) Multiple doses/ Half the number of prescribed doses
d) Entire number doses prescribed
e) More than prescribed number of doses

7. Do you believe long term effects of chronic use of pain medication for long duration?

a) Strongly Agree
b) Agree
c) Neutral
d) Disagree
e) Strongly Agree

Department of Pharmacy Practice, HCOPARC Page 92

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