NATIONAL BOARD OF EXAMINATIONS (New Delhi)

Thesis Protocol Submission

Name of the Candidate: Dr. Rio Rocky

Subject: Anesthesiology (Secondary)

Provisional Registration No: Testing ID: CD1707531

Date of Joining: 05 May 2017

Hospital / Institute: Sahyadri Narayana Multispecialty Hospital

N T Road, Harakere, Shimoga
Karnataka 577202

Thesis Topic: Effect of Dexmedetomidine as an adjuvant to

Ropivacaine for Transverse Abdominis Plane
block for post-Cesarean analgesia; a prospective,
randomized, double-blinded study.

Guide Name: Dr. Ajith Kumar Shetty

Head and Consultant,
Department of Anesthesiology,
Sahyadri Narayana Multispecialty Hospital,
Shimoga 577202
Karnataka

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1.1 Introduction

Cesarean section is one of the most commonly performed surgeries on women of

child-bearing age. In India, the rate of cesarean section delivery, overall, is 9 percent1. Patients
experience moderate to severe pain after cesarean section. Adequate management of post-
cesarean pain is crucial, as inadequate analgesia may affect mother-baby bonding, care of
baby, breastfeeding2, and may even risk the patients for thrombo-embolic phenomena as a
result of immobility due to pain3.
Multiple modalities have been used to alleviate pain after cesarean section such as
intravenous(IV) and neuraxial opioids, oral and intravenous nonsteroidal anti-inflammatory
drugs (NSAIDs), local anesthetic wound infiltration and transverse abdominis plane block,
non-pharmacological techniques such as Transcutaneous Electrical Nerve
Stimulation(TENS), hypnosis etc. Systemic or neuraxial opioids are the mainstay of
postoperative pain control, but they are associated with a number of side effects such as
nausea, vomiting, pruritus and respiratory depression4. In addition, it has been observed that
systemic morphine accumulates in breast milk and can be transferred to the baby if the patient
is breastfeeding5. Non-Steroidal Anti-inflammatory Drugs (NSAIDs) and Paracetamol can
only supplement other modes of analgesia and are not sufficient on their own; and have their
own side-effects like bleeding, platelet dysfunction and renal damage6. Epidural analgesia can
provide excellent pain relief and may decrease patient morbidity. However, this technique has
significant risks including epidural abscess, meningitis and epidural hematoma7.
Transverse Abdominis Plane (TAP) block, as a part of multimodal analgesia post-
cesarean section, is gaining popularity. TAP block is a type of peripheral nerve block that
involves innervations of the anterolateral abdominal wall derived from T10 - L18. TAP block
is achieved by injecting local anesthesia into the plane between the internal oblique and
transversus abdominis muscle8. These nerves are accessed through lumbar triangle of Petit.
This triangle is bounded anteriorly by the external oblique muscle and posteriorly by the
latissimus dorsi muscle, whereas the base is formed by the iliac crest8. Recently, Ultrasound
(US) guided TAP block has gained much acclaim over landmark-based technique. US-guided
nerve blocks offer the advantage of real-time imaging of the needle trajectory and injectate
spread, which may improve both safety and effectiveness of TAP block9.
Various local anesthetics (LA) have been used for peripheral nerve blockade.
Longer acting LAs such as Bupivacaine and Ropivacaine are preferred over shorter acting
ones like Lidocaine and Mepivacaine. Ropivacaine structurally resembles Bupivacaine and
has got a significantly higher threshold for cardiotoxicity and Central Nervous System toxicity
than Bupivacaine, thus having a better safety profile10.
Addition of adjuvants to LAs have been found to increase the duration and quality
of peripheral nerve blockade. Dexmedetomidine is a highly selective α2 agonist (α1:α2 ratio of
1:1600) with both analgesic and sedative properties. Its use with LA in regional blocks is
associated with prolongation of LA effect11.

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 Dexmedetomidine has been extensively used as an adjuvant to LAs in central
neuraxial techniques and various peripheral nerve blocks. There are not many studies
evaluating the effect of Dexmedetomidine with Ropivacaine in TAP block for post-cesarean
analgesia. Hence, this study is undertaken to assess the efficacy of Dexmedetomidine with
Ropivacaine for TAP block as a part of multimodal analgesia in parturients undergoing
elective Lower Segment Cesarean Section (LSCS)

1.2 Review of Literature

1. Mankikar MG et al12 studied analgesic efficacy of US-guided TAP block with
Ropivacaine in patients undergoing Lower Segment Cesarean Section (LSCS) under
Spinal Anesthesia. Sixty patients were randomized to receive either TAP block with
0.5% Ropivacaine (15mL either side) or with normal saline (n=30) at the end of
surgery. Standard analgesia with intravenous Paracetamol and Tramadol were given to
both the groups at the end of surgery. They observed the time of first request for
analgesic, total Tramadol consumption in 24 hours and Visual Analogue Scale (VAS)
scores at regular intervals. Time for rescue analgesia in the study group was found to
be significantly prolonged when compared to the control group. Mean Tramadol
consumption and VAS scores were significantly reduced in the study group. The study
concluded that US-guided TAP block with Ropivacaine reduces post-operative opioid
consumption in cesarean section patients.

2. Srivastava U et al13 conducted a randomized double-blind trial to study the efficacy

of TAP block with 20 mL of 0.25% Bupivacaine as a part of multi-modal analgesia in
patients undergoing cesarean section under spinal anesthesia. 62 parturients were
randomized to undergo TAP block or no TAP block at the end of surgery (n=31). Both
the groups received Diclofenac 75mg intravenous (IV) at the end of surgery and 8th
hourly and IV patient-controlled analgesia (PCA) with Tramadol. 48 hour Tramadol
consumption, pain scores, time of first analgesia, side-effects and patient satisfaction
were observed. Tramadol consumption in patients who were given TAP block was
reduced by 50% compared to patients who were given no block. They conclude that
TAP block was an effective mode of analgesia with substantial reduction in analgesic
requirement when used as an adjunct to standard analgesia.

3. Baaj JM et al14 evaluated the efficacy of TAP block for post-cesarean analgesia. 40
patients undergoing cesarean section under spinal anesthesia were randomized to
receive bilateral ultrasound-guided TAP block with 20mL of either Bupivacaine 0.25%
or normal saline, at the end of surgery. Both the groups received patent-controlled
analgesia with IV Morphine. Total Morphine consumption in 24 hours was the primary

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 outcome studied. It was reported that total Morphine consumption was reduced by 60%
in Bupivacaine group with improved satisfaction over 24 hours after surgery.

4. McDonnell JG et al15 conducted a randomized controlled double-blind clinical trial to

evaluate analgesic efficacy of TAP block for post-cesarean analgesia. 50 women
undergoing elective cesarean delivery under spinal anesthesia were randomized to
undergo TAP block with 0.75% Ropivacaine 1.5mg/kg to a maximum dose of 150mg
per side versus placebo (n=25). Additional analgesia was given with rectal Diclofenac
and Paracetamol at the end of surgery and at regular intervals post-operatively. Patient
controlled analgesia was given with IV Morphine. 48 hour Morphine consumption was
significantly reduced in patients who received TAP block with Ropivacaine. They
concluded that TAP block as a component of multi-modal analgesic regimen provided
superior analgesia.

5. Belavy D et al16 evaluated the analgesic efficacy of US guided TAP block in patients
undergoing cesarean delivery. 50 women undergoing cesarean delivery, under spinal
anesthesia, were randomly divided into two groups receiving bilateral US guided TAP
block with either 0.5% Ropivacaine (n=25) or saline (n=25), at the end of surgery. All
patients received post-operative Paracetamol, NSAIDs, and patient controlled IV
Morphine. Each patient was assessed for 24 hour morphine usage, average pain score,
nausea, vomiting, pruritus, drowsiness, and satisfaction with pain relief. 24 hour
Morphine consumption was found to be reduced in patients who received TAP block
with Ropivacaine, with improved satisfaction with pain relief. They concluded that US-
guided TAP block reduces Morphine requirements after cesarean delivery when used
as a component of multimodal analgesia.

6. Singh R et al17 compared duration of post-operative analgesia with TAP block using
Bupivacaine alone versus Bupivacaine with Clonidine in patients undergoing LSCS
under spinal anesthesia. 100 patients were randomly divided to receive bilateral TAP
block by landmark technique with either 20 mL Bupivacaine 0.25% or 20mL
Bupivacaine with Clonidine 1mcg/kg after surgery. Patients were given rescue
analgesic with Diclofenac 1mg/kg IV on demand or if the VAS was ≥3. Total duration
of analgesia, total requirement of analgesics in first 24 hours, patient satisfaction and
side effects were studied. Duration of analgesia was significantly longer and mean
consumption of Diclofenac was reduced in patients who received TAP block with
Bupivacaine with Clonidine. They concluded that addition of Clonidine with
Bupivacaine n TAP block provides excellent post-operative analgesia upto 19 hours,
decreases post-operative analgesic requirement with minimal side-effects when
compared to Bupivacaine alone.

7. Luan H et al18 conducted a study to identify the effect of Dexmedetomidine added to

Ropivacaine in US guided TAP block for post-operative analgesia after abdominal

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 hysterectomy under General Anesthesia. 60 patients were randomly divided into two
groups. At the end of surgery, group R (n=30) received bilateral TAP block with 20mL
Ropivacaine 0.3% and 2mL normal saline; whereas group RD (n=30) received 20mL
Ropivacaine 0.3% and Dexmedetomidine 0.5mcg/kg which was diluted to 2mL. VAS
pain scores, frequency of PCA pressed, Sufentanil consumption and post-operative
nausea and vomiting (PONV) were recorded. Compared with group R, the frequency
of PCA pressed and consumption of Sufentanil were significantly lower in group RD.
There was no significant difference between the two groups with respect to other
parameters studied. They concluded that US-guided TAP block could be an effective
component of multi-modal post-operative analgesia and adding Dexmedetomidine
potentiated the analgesic properties of Ropivacaine.

8. Venkatraman R et al19 conducted a study to gauge the analgesic efficacy of US-

guided TAP block in patients undergoing unilateral inguinal hernia repair. 60 patients
were randomized into two groups and received US-guided TAP block with 20mL of
either 0.2% Ropivacaine (group A; n=30) or normal saline (group B; n=30) at the end
of surgery. Pain was assessed using VAS score at regular interval, and patients were
given IV Paracetamol and Tramadol if VAS scores were more than 3 and 6
respectively. VAS scores and 24 hour analgesic consumption were assessed. It was
found that duration of analgesia lasted longer and total analgesics consumption was
significantly reduced in group A. They concluded that US-guided TAP block provides
good post-operative analgesia, reduces analgesic requirements, and provides good
VAS scores with fewer complications following inguinal hernia repair.

9. Mishra M et al20 performed a randomized, double-blinded study to assess the analgesic

effect of adding Dexmedetomidine to Ropivacaine on TAP block for patients
undergoing lower abdominal surgeries. Forty patients undergoing lower abdominal
surgeries under General Endotracheal Anesthesia were randomized into two groups;
one receiving bilateral US-guided TAP block with 20mL of 0.2% Ropivacaine and
2mL normal saline (group R, n=20), and another group receiving 20mL of 0.2%
Ropivacaine and Dexmedetomidine 0.5mcg/kg dissolved in 2mL of normal saline
(group RD, n=20). The block was performed before the surgery. Pain scores on VAS
were significantly lower in group RD. The study concluded that addition of
Dexmedetomidine to Ropivacaine improves the analgesic effect of TAP block and
prolongs the duration of analgesia.

10. Rai P et al21, in a prospective, double-blinded, randomized study, evaluated the

analgesic advantage of adding Dexmedetomidine to Ropivacaine in TAP block for
patients undergoing Lower Segment Cesarean Section. 100 patients scheduled to
undergo LSCS under spinal anesthesia were randomized into two groups; group R, in
which patients received bilateral TAP block with 20mL of Ropivacaine 0.25% and 2mL
normal saline on each side; and group RD, in which patients received 20mL
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 Ropivacaine 0.25% with Dexmedetomidine 0.5mcg/kg dissolved in 2mL normal
saline. The block was performed by blind technique, before skin incision. Rescue
analgesia, in the post-operative period, was given with IV Tramadol when VAS score
was more than three or on patient request. Time for first dose of analgesic was found
to be longer in group RD. VAS scores and total Tramadol consumption were
significantly lower in group RD when compared to group R. the study concluded that
addition of Dexmedetomidine to Ropivacaine in TAP block helps achieve better
analgesia and decreases the total dose of analgesics without any major side-effects.

1.3 Aims & Objectives

The aim of the study is to evaluate whether addition of 0.5mcg/kg of
Dexmedetomidine to 0.375% Ropivacaine in bilateral TAP block increases the duration of
post-operative analgesia, when compared to 0.375% Ropivacaine alone in parturients
undergoing elective LSCS under spinal anesthesia with 0.5% hyperbaric Bupivacaine.
Primary objective:
>Time for first analgesic request in the post-operative period
Secondary objective:
>Total analgesic consumption in first 24 hours
>VAS scores at 0, 2, 4, 6, 8, 12, 18, 24 hours post-operatively
>Adverse effects – post-operative nausea and vomiting (PONV), dry mouth,
sedation, hypotension, bradycardia
>Patient satisfaction with pain management

1.4 Material & Methods

A clinical study entitled “Effect of Dexmedetomidine as an adjuvant to Ropivacaine
for Transverse Abdominis Plane block for post-Cesarean analgesia; a prospective,
randomized, double-blinded study” will be undertaken at Sahyadri Narayana Multispecialty
Hospital, Shimoga, during the period of August 2017 to July 2018. After institutional Ethical
Committee clearance, 60 parturients fulfilling following inclusion criteria will be enrolled in
the study.

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Inclusion criteria:
1. ASA physical status II,
2. Patients weighing between 50 to 80kg,
3. Posted for elective LSCS, via Pfannenstiel incision, under spinal anesthesia with 0.5%
hyperbaric Bupivacaine.
Exclusion criteria:
1. Patient refusal
2. Contraindications to spinal anesthesia
3. Local infection at the site of block
4. Allergy to study medications
5. Coagulation disorders
6. Psychological disorders.

Methodology:
The recruited patients will be divided into two equal groups of 30 each to receive
either:
Group R (n=30): TAP block with 20mL of 0.375% Ropivacaine plus 2mL normal saline on
each side.
Group RD (n=30): TAP block with 20mL of 0.375% Ropivacaine plus 0.5mcg/kg of
Dexmedetomidine diluted to 2mL normal saline on each side.
A detailed pre-anesthetic evaluation will be done on the day before surgery.
Informed consent will be obtained from all the parturients. Parturients will be explained about
VAS scores, 0 being no pain and 10 being the worst imaginable pain, and pre-operative nil
per oral status. On the day of surgery, all the parturients will be preloaded with 10mL/kg of
Ringer’s Lactate and premedicated with Inj. Rantidine 50mg IV and Inj. Metoclopramide
10mg IV 30 minutes prior to surgery. After shifting to operating table multiparameter monitors
(GE B20) will be connected and basal heart rate, blood pressure and peripheral oxygen
saturation will be recorded. Under aseptic precautions, parturients will receive spinal
anesthesia with 1.8mL of 0.5% hyperbaric Bupivacaine with 25 microgram of Fentanyl.
At the end of surgery, all parturients will receive bilateral US guided TAP block.
Parturients will be randomly allocated to two groups.
Group R (n=30): 20mL of 0.375% Ropivacaine plus 2mL normal saline on each side.
Group RD (n=30): 20mL of 0.375% Ropivacaine plus 0.5mcg/kg of Dexmedetomidine diluted
to 2mL normal saline on each side.
Randomization will be performed using computer generated random number. The
number will be concealed and sealed in opaque envelopes, which will be opened prior to the
performance of block. The study drug will be prepared by an assistant not involved in the
study. The patient and anesthesiologist performing and collecting the data will be blinded to
the study drug.

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 After skin preparation, TAP block will be administered using ultrasound guidance
(SonoSite Edge). A high frequency (6–13MHz) US linear probe will be placed transverse to
abdominal wall in mid-axillary line, midway between costal margin and iliac crest, in the
triangle of Petit. After visualizing three muscular planes (External Oblique, Internal Oblique
and Transverse Abdominis muscles), the needle will be introduced by in-plane approach and
advanced until it reaches the plane between Internal Oblique and Transverse Abdominis
muscles. Study drug will be injected after negative aspiration for blood and the spread of drug
in the plane will be observed. The same procedure will be repeated on the other side. Time of
completion of block procedure will be considered as time zero. All parturients will receive
Paracetamol 1g IV infusion and Diclofenac suppository 100mg.
In the post-operative period, parturients will be assessed for pain by VAS score at
2, 4, 6, 8, 12, 18 and 24 hours. Rescue analgesia will be given on demand or if VAS score ≥
4, in the form of Tramadol 2mg/kg IV. Time for first request of analgesia and total Tramadol
consumption in the first 24 hours will be recorded. Sedation scores will be evaluated using
Ramsay sedation scale as follows
1. Anxious and agitated or restless, or both
2. Co-operative, oriented and tranquil
3. Responds to command only
4. Exhibits brisk response to light glabellar tap or loud auditory stimulus
5. Exhibits sluggish response to light glabellar tap or loud auditory stimulus
6. No response to light glabellar tap or loud auditory stimulus
Patient satisfaction with pain management will be assessed by a four point score20.
1. extremely satisfied
2. satisfied
3. dissatisfied
4. extremely dissatisfied
Patients will be observed for other associated side-effects like dry mouth, nausea, vomiting,
hypotension (< 20% of baseline), and bradycardia (< 60 bpm).

Statistical methods and analysis:

Sample size was calculated using mean and standard deviation from the study
conducted by Venkatraman R et al19. We hypothesized that addition of Dexmedetomidine to
Ropivacaine will prolong the time for first request for analgesia and we assumed a difference
of 3 hours to be clinically significant. Based on the above assumptions, we derived a sample
size of 52. Considering drop out cases, a sample size of 60 patients will be used for the study.
Statistical data will be analyzed using Statistical Package for Social Sciences (SPSS
Inc., Chicago, IL, USA, version 17.0 for windows). Demographic data will be analyzed using
Student's t test or Fisher's exact test as appropriate. The comparison of total tramadol
requirement, time to first analgesic administration and VAS between the two groups will be
done by paired t test. A p < 0.05 will be considered statistically significant.

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 1.5 References

1. IIPS and Macro International (2007): National Family Health Survey (NFHS-3), 2005-2006,
India, Vol. I and Vol. II, International Institute for Population Sciences, Mumbai.
2. Leung AY. Postoperative pain management in obstetric anaesthesia – new challenges and
solutions. J Clin Anaesth. 2004;16(1):57–65
3. Gadsden J, Hart S, Santos AC. Post-cesarean delivery analgesia. Anesth Analg.
2005;101:S62–9. doi: 10.1213/01.ANE.0000177100.08599;.C8
4. Tan TT, Teoh WH, Woo DC, Ocampo CE, Shah MK, Sia AT. A randomised trial of the
analgesic efficacy of ultrasound-guided transversus abdominis plane block after caesarean
delivery under general anaesthesia. Eur J Anaesthesiol. 2012;29:88–94
5. Baka NE, et al. Colostrum morphine concentrations during postcesarean intravenous patient-
controlled analgesia. Anesth Analg. 2002;94(1):184–7
6. Sujata N, Hanjoora VM (2014) Pain Control After Cesarean Birth – What are the Options?. J
Gen Pract 2:164. doi:10.4172/2329-9126.1000164
7. Christie IW, McCabe S. Major complications of epidural analgesia after surgery: results of a
six-year survey. Anaesthesia. 2007;62(4):335–41. Epub 2007/03/27. doi: 10.1111/j.1365-
2044.2007.04992.x .
8. Horlocker TT, Kopp SL, Wedel DJ. Peripheral nerve blocks. Chapter 57. In: Miller’s
Anaesthesia. 8th ed. Philadelphia:Elsevier Saunders;2015. pp.1735
9. Barrington MJ, Ivanusic JJ, Rozen WM, Hebbard P. Spread of injectate after ultrasound-
guided subcostal transversus abdominis plane block: a cadaveric study. Anaesthesia.
2009;64(7):745–750.
10. K Knudsen, M Beckman Suurküla, S Blomberg, J Sjövall, N Edvardsson; Central nervous
and cardiovascular effects of i.v. infusions of ropivacaine, bupivacaine and placebo in
volunteers.. Br J Anaesth 1997; 78 (5): 507-514. doi: 10.1093/bja/78.5.507
11. Yoshitomi T., Kohjitani A., Maeda S., Higuchi H., Shimada M., Miyawaki T.
Dexmedetomidine enhances the local anesthetic action of lidocaine via an α-2a adrenoceptor.
Anesthesia and Analgesia. 2008;107(1):96–101. doi: 10.1213/ane.0b013e318176be73.
12. Mankikar MG, Sardesai SP, Ghodki PS, Ultrasound-guided transversus abdominis plane
block for post-operative analgesia in patients undergoing cesarean section. Indian J Anaesth
2016;60:253-7.
13. Srivastava U, Verma S, Singh TK, Gupta A, Saxsena A, JagarKD et al. Efficacy of trans
abdominis plane block for post cesarean delivery analgesia: A double blind, randomized trial.
Saudi J Anaesth 2015;9:298-302
14. Baaj JM, Alsatli RA, Majaj HA, Babay ZA, Thallaj AK. Efficacy of ultrasound-guided
transversus abdominis plane (TAP) block for postcesarean section delivery analgesia--a
double-blind, placebo-controlled, randomized study. Middle East J Anesthesiol.
2010;20:821–6
15. McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, et al. The analgesic
efficacy of transversus abdominis plane block after cesarean delivery: A randomized
controlled trial. Anesth Analg. 2008;106:186–91

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16. Belavy D, Cowlishaw PJ, Howes M, Phillips F. Ultrasound-guided transversus abdominis
plane block for analgesia after caesarean delivery. Br J Anaesth 2009;103:726-30.
doi:10.1093/bja/aep235
17. Singh R, Kumar N, Jain A, Joy S. Addition of clonidine to bupivacaine in transversus
abdominis plane block prolongs postoperative analgesia after cesarean section. J
Anaesthesiol Clin Pharmacol 2016;32:501-4
18. Luan H, Zhang X, Feng J, Zhu P, Li J, Zhao Z. Effect of dexmedetomidine added to
ropivacaine on ultrasound-guided transversus abdominis plane block for postoperative
analgesia after abdominal hysterectomy surgery: a prospective randomized controlled trial.
Minerva Anestesiol 2016;82:981-8.
19. Venkatraman R, Abhinaya RJ, Sakthivel A, Sivarajan G. Efficacy of ultrasound-guided
transversus abdominis plane block for postoperative analgesia in patients undergoing
inguinal hernia repair. Local and Regional Anesthesia. 2016;9:7-12.
doi:10.2147/LRA.S93673.
20. Mishra M, Mishra SP, Singh SP. Ultrasound-guided transversus abdominis plane block:
What are the benefits of adding dexmedetomidine to ropivacaine? Saudi Journal of
Anaesthesia. 2017;11(1):58-61. doi:10.4103/1658-354X.197348.
21. Rai P, Singh D, Singh SK, Malviya D, Bagwans MC. Effect of addition of dexmedetomidine
to ropivacaine in transversus abdominis plane block on postoperative pain in lower segment
caesarean section: A randomized controlled trial. J Dent Med Sci. 2016;15:122–5.

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 1.5 STUDY PROFORMA

Name: Age: MR No:

Date of Admission: Date of Surgery:

Address: Diagnosis:

Pre-anesthetic Evaluation
Significant history:

Past surgical history/anesthetic exposure:

Comorbidities:

Known allergies:

General Physical examination: Weight:

Height:
BMI:
Pulse: Blood Pressure: Respiratory Rate:

Pallor Icterus Cyanosis Clubbing Lymphadenopathy

Airway Examination:

Mouth opening: Teeth:

Neck Extension: TMD:
MP class:

Systemic Examination:

CVS: P/A:

RS: CNS:

Page 11 of 15
Investigations: ASA Physical Status:

Premedication:

Technique:

Spinal anesthesia:

TAP block:

Time of completion of TAP block (Time zero):

Time for first request of analgesia:

Total tramadol consumption in 24 hours:

VAS scores:

VAS
SCORE

TIME 1 2 3 4 5 6 7 8 9 10
(HOURS)

12

18

24

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Ramsay sedation scale:

SEDATION
SCALE
1 2 3 4 5 6
TIME
(HOURS)

12

18

24

Patient satisfaction:

Any adverse events:

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 INFORMED CONSENT FORM

Subject identification number for this trial __________________________________

Title of the Project: “Effect of Dexmedetomidine as an adjuvant to Ropivacaine for

Transverse Abdominis Plane block for post-Cesarean analgesia; a prospective,
randomized, double-blinded study”

Name of the principal investigator: Dr. Rio Rocky Tel. No. + 91 7760585534

I have received the information sheet on the above study and have read and / or understood
the written information.

I have been given the chance to discuss the study and ask questions.

I consent to take part in the study and I am aware that my participation is voluntary.

I understand that I may withdraw at any time without this affecting my future care.

I understand that the information collected about me from my participation in this research
and sections of any of my medical notes may be looked at by responsible persons (ethics
committee members/regulatory authorities). I give access to these individuals to have access
to my records.

I understand I will receive a copy of the patient information sheet and the informed consent
form.

Subject Legally accepted Witness Investigator

representative
Name

Signature/Thumb
Impression

Date

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APPROVAL OF SCIENTIFIC COMMITTEE AND ITS COMPOSITION

APPROVAL OF ETHICS COMMITTEE AND ITS COMPOSITION

(Signature of the candidate) (Signature of the guide)

(Signature of the Head of department)

(Signature of Head of institution)

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