JOURNAL

APPRAISAL
Group 7B
Subgroup 2

February 24,2021

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PRAYER

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 PRESENTERS

Bellosil
Alih Jogani Villa
o

Wong

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EPIDURAL ANALGESIA DURING
THE SECOND STAGE OF LABOR

Shen, XiaoFeng MD; Li, Yunping MD; Xu, ShiQin MD;

Wang, Nan MD; Fan, Sheng MD; Qin, Xiang RN; Zhou,
Chunxiu RN; Hess, Philip E. MD
REACTOR

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 DEFINITION OF TERMS

Labor – It is the process that leads to childbirth; begins with the onset of regular uterine
contractions and ends with delivery of the newborn and expulsion of the placenta
1. The first stage of labor begins when spaced uterine contractions of sufficient frequency, intensity,
and duration are attained to bring about cervical thinning, termed effacement.
• The stage of cervical effacement and dilation.
2. The second stage begins when cervical dilation is complete and ends with delivery.
• The stage of fetal expulsion.
3. The third stage begins immediately after delivery of the fetus and ends with the delivery of the
placenta.
• The stage of placental separation and expulsion.

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• Epidural analgesia – It is a central nerve blockade technique, which involves the
injection of a local anesthetic with or without an adjunct into the epidural space of the
lower region of the spine close to the nerves that transmit painful stimuli from the
contracting uterus and birth canal; is widely used as a form of pain relief in labor and
maybe given by bolus injection, continuous infusion or using a patient-controlled pump.

• Ropivacaine - a long-acting amide local anesthetic agent that causes reversible

inhibition of sodium ion influx, and thereby blocks impulse conduction in nerve fibers.
It is less lipophilic and is less likely to penetrate large myelinated motor fibers, resulting
in a relatively reduced motor blockade.

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• Sufentanil - a synthetic, potent opioid with highly selective binding to μ-
opioid receptors; like other opioids, it decreases cAMP (affecting neural
signaling pathways), decreases neurotransmitter release, and causes
membrane hyperpolarization, all of which contribute to the relief of painful
symptoms

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 INTRODUCTION

• A longer duration of the second stage labor is associated with adverse outcomes,
including chorioamnionitis, perineal laceration, and postpartum hemorrhage.

• Thus, any treatment that affects the progress and outcome of the second stage of
labor would be of great interest to obstetricians, anesthesiologists, and pregnant
women.

• Epidural analgesia is the most effective method of labor pain relief, but both
observational and some randomized studies have found an association with
prolonged duration of the second stage of labor and increased rates of instrumental
vaginal delivery. 9
• During the second stage of labor, some obstetric care providers
request a reduction or termination in the rate of epidural infusion to
improve maternal expulsive efforts.

• Despite the minimal motor blockade, many obstetric care providers

continue to request termination of the epidural infusion for the second
stage of labor.

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 GOAL OF THE STUDY

• To evaluate whether maintaining a motor-sparing epidural

analgesia infusion affects the duration of the second stage of
labor in nulliparous parturients compared with a placebo control.

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METHODS
 STUDY DESIGN

• prospective, randomized, placebo-controlled trial

• approved by both Human Research Committee–institutional review board for
Clinical Research from Nanjing Maternity and Child Health Care Hospital
(Nanjing, China) and Beth Israel Deaconess Medical Center (Boston,
Massachusetts).
• The study was registered on December 20, 2014
 INCLUSION CRITERIA

• Participants who were in labor but did not yet have epidural analgesia were
screened for study participation.
• Written informed consent was obtained by a study investigator before
enrollment.
• Included were:
• healthy nulliparous women with term (37 weeks of gestation or greater)
• live, singleton pregnancies who presented in spontaneous labor
• desired neuraxial analgesia.
 EXCLUSION CRITERIA

• American Society of Anesthesiologists physical status 3 or 4

• history of opioid use
• receiving magnesium
• having received intravenous or oral analgesics during labor
• cervical dilation 6 cm or greater at epidural request
• Participants who agreed to participate, but underwent cesarean delivery before full
cervical dilation, delivered within 1 hour after epidural catheter placement, or had
a nonfunctional epidural catheter that needed to be replaced to provide pain relief
 Computer-generated in 4 equal
blocks (100/block) &
maintained in the U.S. center,
Beth Israel Deaconess Medical
Center

Folded note cards with patient

allocation were placed in
sequentially numbered, sealed,
opaque envelopes, and delivered
to the clinical site
RANDOMISATION

A single study investigator

opened the envelope, prepared
the study epidural medications
and had no further participation
in the study

To further prevent potential bias,

the obstetricians and midwives
involved in obstetric
management did not participate
in data collection.
 At the time of maternal request for labor analgesia,
the patient's cervix was examined.

Per hospital practice, the cervix was checked every

2 hours or as indicated. After epidural catheter
placement, the patient received a standard protocol
for labor epidural analgesia followed by another
infusion of the same solution.

At full cervical dilation, remaining eligible, par-

ticipants were randomized to receive the study
solution containing either normal saline (SALINE)
or the standard epidural solution (EPIDURAL).
PROCEDURES
To maintain blind- ing, the epidural solution
containers were labeled only with the study number;
thus, parturients, investiga- tors, obstetricians, and
midwives were not aware of the group assignment.

At the request of the obstetric care provider,

participants could have their epidural infusion termi-
nated for clinical indications.

Breakthrough pain during the first or second stage of

labor was treated with either patient-controlled
epidural analgesia or a physician-administered bolus,
as needed.

During the second stage of labor, participants

with excessive pain were allowed be changed to
an unblinded infusion of epidural medication.
OUTCOMES
 PRIMARY OUTCOME

• The duration of the 2nd stage of labor, calculated from the time of full cervical
dilatation until delivery.
 SECONDARY OUTCOMES

• pain scores assessed with a visual analog scale (a 100-mm unmarked line with
endpoints labeled “no pain” and “worst pain imaginable” in Chinese)
• motor block measured with a modified Bromage score
 SECONDARY OUTCOMES

• patient satisfaction with labor analgesia was assessed on a 11-point Likert scale and
evaluated at least 1 hour after delivery but before discharge from the labor and delivery unit
• the mode of delivery
• use of episiotomy
• fetal position at delivery
• neonatal Apgar scores
• umbilical blood gas results
• the need for supplemental patient-controlled epidural analgesia or physician- administered
boluses or a change to the epidural infusion during the 2nd stage
 STATISTICAL ANALYSIS

• Continuous outcomes were compared using two-sided Student t test or Mann-

Whitney U test when not normally distributed.
• The Shapiro-Wilk test was used to assess the distribution of the data.
• Categorical data were compared using Fisher exact test.
• Data were analyzed on an intent-to-treat basis with statistical significance
determined at P<.05
 RESULTS

• A total of 560 pregnant women were screened for eligibility, and 119 women
were excluded based on criteria
• Another 41 patients were excluded because they had a cesarean delivery in the
first stage of labor or vaginal delivery within 1 hour of epidural catheter
placement.
• Four hundred parturients reached the second stage of labor, were randomized
(200 in each group)
 RESULTS

• The assigned blinded study solution. There were no significant differences in

demographic or obstetric characteristics between the EPIDURAL and SALINE
groups
RESULTS
 RESULTS

• The primary outcome, the duration of the second stage of labor, was similar
between groups with a 3.3% difference in the duration of the second stage of
labor
 RESULTS

• There were no statistical differences in visual analog scale pain scores between
groups at any evaluation.
• Pain scores decreased in the EPIDURAL group until the 90-minute mark,
whereas pain scores increased in the SALINE group throughout.
• The maternal satisfactions cores for pain relief were lower in the SALINE
group (median9 [range8–10]) than in the EPIDURAL group (median10[10–
10],P,.001].
• In post hoc analysis , only 32(16%) of the EPIDURAL group had satisfaction
scores of 8 or less compared with 61(30.5%)of theSALINE group(P=.001).
 RESULTS

• There were no cases in which the epidural infusion was converted to an

unblinded, medicated solution.
DISCUSSION

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• Found that exchanging the epidural solution from one containing local
anesthesia to a placebo saline control had no effect on the duration of the
second stage of labor.
• No effect on the normal vaginal delivery rate, incidence of episiotomy, the
position of the fetus at delivery, or any measure of neonatal well-being.
• Used a very low concentration of ropivacaine (0.8%), which has a relative
potency equal to approximately 0.05% bupivacaine 0.9

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• . Finally, although the absolute rate of spontaneous vaginal delivery was very
high—as would be expected in a study that starts with the onset of the second
stage of labor—the rate in the epidural group was slightly lower.
• This was not our primary outcome; thus, it is possible that our study was
underpowered to detect such a small difference in absolute rates.
• In summary, stopping the epidural infusion at the start of the second stage of
labor does not affect the duration or any other outcome, with the exception of
possibly resulting in lower maternal satisfaction

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 ROLE OF FUNDING

• The authors did not report any potential conflicts of interest.

CRITICAL APPRAISAL

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 1. DID THE STUDY ADDRESS A
CLEARLY FORMED QUESTION/ISSUE?

YES
• Population
• Nulliparous women with term cephalic singleton pregnancies who requested analgesia
• Intervention
• All of them received 0.08% ropivacaine with 0.4 mcg/ml sufetanil
• Comparison
• Placebo of saline solution
• Outcome
• Evaluate duration of the second stage of labor if motor sparing epidural analgesia is
continued to be given.
2. WAS THE ASSIGNMENT OF THE
PATIENTS TO TREATMENT
RANDOMISED?

YES
3. WERE THE GROUPS SIMILAR AT THE START
OF THE TRIAL?

YES

There were no significant differences in

demographic or obstetric characteristics between
the EPIDURAL and SALINE groups.
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4. ASIDE FROM THE ALLOCATED TREATMENT,
WERE GROUPS TREATED EQUALLY?

YES

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 5. WERE ALL THE PATIENTS WHO ENTERED THE TRIAL
ACCOUNTED FOR? AND WERE THEY ANALYSED IN THE
GROUPS TO WHICH THEY WERE RANDOMISED?

YES

All the patients who entered the trial accounted and analysed the
groups which they were randomized
 6. WERE MEASURES OBJECTIVE OR WERE THE PATIENTS AND
CLINICIANS KEPT BLIND TO WHICH TREATMENT WAS BEING
RECEIVED

YES

To maintain blinding, the epidural solution containers were labeled only with the
study number; thus, parturients, investigators, obstetricians, and midwives were
not aware of the group assignment.
 7. HOW LARGE WAS THE
TREATMENT EFFECT?
• What outcomes were measured?
• Is the primary outcome clearly specified?
• What results were found for each
outcome?
• Four hundred parturients reached the
second stage of labor, were randomized
(200 in each group), and had the epidural
solution changed to the assigned blinded
study solution.
 7. HOW LARGE WAS THE
TREATMENT EFFECT?

• What outcomes were measured? • the duration of the second stage of labor,
calculated from the time of full cervical
• Is the primary outcome clearly
dilation until delivery.
specified?
• What results were found for each
outcome?
 7. HOW LARGE WAS THE TREATMENT EFFECT?
• What outcomes were measured?
• Is the primary outcome clearly specified?
• What results were found for each outcome?
PRIMARY OUTCOME
• duration of 2ND stage of labor: similar with a 3.3%
difference
• median times were also similar:
• EPIDURAL at 45 minutes (range 33–61 minutes)
• SALINE at 46 minutes (range 34– 60 minutes; P5.94).
• number of fetuses malrotated at delivery:
• EPIDURAL 7 [3.5%]
• SALINE 6 [3%];
• P5.98,
• difference 0.5%, 95% CI 23.4 to 4.5%).
 7. HOW LARGE WAS THE TREATMENT EFFECT?
• What outcomes were measured?
• Is the primary outcome clearly specified?
• What results were found for each outcome?
PRIMARY OUTCOME
• number of cesarean deliveries, forceps deliveries, and
episiotomies in both groups - similar
• spontaneous vaginal delivery rate: not statistically different
• EPIDURAL 193 [96.5%]
• SALINE 198 [99%]
• P5.17
• difference 3.5%, 95% CI 20.9 to 5.9%)
• neonatal weight slightly higher in the SALINE group,
• neonatal outcomes: no other significant differences
including Apgar scores at 1 minute and 5 minutes,
umbilical artery pH, and acid base
 7. HOW LARGE WAS THE TREATMENT EFFECT?
• What outcomes were measured?
• Is the primary outcome clearly specified?
• What results were found for each outcome?
SECONDARY OUTCOME
• VISUAL ANALOG PAIN SCALE: no statistical
differences
• PAIN SCORES:
• EPIDURAL: decreased until 90-minute mark
• SALINE: increased through-out
• MATERNAL SATISFACTION SCORE FOR PAIN
RELIEF:
• SALINE GROUP: lower (median 9 [range 8–10]
• EPIDURAL group (median 10 [10–10]
• P,.001
 7. HOW LARGE WAS THE TREATMENT EFFECT?

SECONDARY OUTCOME
• What outcomes were measured? • Post hoc analysis:
• Is the primary outcome clearly specified? • EPIDURAL: 32 (16%) had satisfaction scores of 8 or
less
• What results were found for each outcome?
• SALINE: 61 (30.5%)
• (P5.001).
 7. HOW LARGE WAS THE TREATMENT EFFECT?

SECONDARY OUTCOME
• What outcomes were measured? • INFUSION STOPPED IN 49 (12%) patients
• Is the primary outcome clearly specified? • SALINE: 22 (11%)

• What results were found for each outcome? • INDICATIONS: poor progress of labor (n521), high
station (n53), fever (n51), and fetal heart rate
abnormalities (n52)
• EPIDURAL: 27 (13.5%)
• INDICATIONS: poor progress of labor (n517), high
station (n52), and maternal fever (n53).
 7. HOW LARGE WAS THE TREATMENT EFFECT?
• What outcomes were measured?
• Is the primary outcome clearly specified?
• What results were found for each outcome?
SECONDARY OUTCOME
• 35 [71%] stopped before onset of 2nd stage of labor
and before randomization:
• 2 were restarted with the initiation of the blinded study
solution.
• Duration of 2nd stage labor: 54617 minutes
 7. HOW LARGE WAS THE TREATMENT EFFECT?

SECONDARY OUTCOME
• What outcomes were measured? • 14 stopped after full cervical dilation:
• Is the primary outcome clearly specified? • EPIDURAL: 6

• What results were found for each outcome? • SALINE: 8

• median time from onset of 2ND stage to stopping
infusion: 25 minutes (range 11.25–31.5 minutes)
• Duration of 2ND stage: 98635 minutes
• BREAKTHROUGH PAIN TREATED IN 10 PTS:
• EPIDURAL 6 [3%]
• SALINE 4 [2%])
 8. HOW PRECISE WAS THE
TREATMENT EFFECT?

• TREATMENT EFFECT WAS NOT PRECISE.

• The researchers were required to allow obstetricians to manage labor as they believed
safest.
• a number of patients (12%) had their epidural infusion halted before the second stage of
labor
• duration of second stage in these women was the same as those who had their infusion
continued.
• Several patients had epidural infusion discontinued after randomization, presumably
when being identified as having poor progress of fetal descent.
• 2ND stage of labor was longer
 8. HOW PRECISE WAS THE
TREATMENT EFFECT?

• We did find an increased incidence of women who reported lower satisfaction scores with
pain control (8 or less on the 11-point Likert scale) when the infusion was exchanged for
saline.
• Although the pain scores in our study were not statistically different between groups, the
trend of pain scores among women receiving saline infusion was increasing over time, as
would be expected.
• This is consistent with previous studies that demonstrated that withdrawal of local
anesthetics from the epidural infusion leads to higher pain scores on average.
• In both groups in our study, the pain scores evaluated at the 90-minute mark were
considerably higher, which is consistent with a greater amount of pain found in cases of
prolonged labor.
 8. HOW PRECISE WAS THE
TREATMENT EFFECT?

• It is possible that recall bias could result in the differences we observed.

• Finally, although the absolute rate of spontaneous vaginal delivery was very
high—as would be expected in a study that starts with the onset of the second
stage of labor—the rate in the epidural group was slightly lower. This was not
our primary outcome; thus, it is possible that our study was underpowered to
detect such a small difference in absolute rates.
• Stopping the epidural infusion at the start of the second stage of labor does not
affect the duration or any other outcome, with the exception of possibly
resulting in lower maternal satisfaction.
9. CAN THE RESULTS BE APPLIED TO
THE LOCAL POPULATION?

YES
 10. WERE ALL CLINICALLY
IMPORTANT OUTCOMES CONSIDERED?

YES
11. ARE THE BENEFITS WORTH THE
HARMS AND COSTS?

YES
12. WILL THE RESULTS HELP ME IN
CARING FOR MY PATIENT?

YES
 STRENGTHS
• Double blind
• Randomized
 WEAKNESS
• Single Centre
• Small sample size
• The study analysed the data from labouring women with
the same ethnicity
 CONCLUSION
• In maintaining the infusion of epidural medication had no effect on the
duration of the second stage of labor compared with a placebo
infusion.

• The study also showed that maternal and neonatal outcomes were
similar. A low concentration of epidural local anesthetic does not
affect the duration of the second stage of labor.
 RECOMMENDATIONS
• To conduct larger multicentre, randomized, double-
blind, placebo trial.
• Large sample size in conducting the study.