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Original Article

Effect and Safety of Labor Epidural Analgesia with Intermittent


Boluses of 0.1% Bupivacaine with Fentanyl on Fetal and
Maternal Outcomes and Wellbeing
Rajesh Kesavan, Sunil Rajan, Lakshmi Kumar
Department of Anaesthesiology, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India

Abstract
Background: Labor analgesia has been shown to have few undesirable effects on the course and outcome of the labor as well as on the
fetal well‑being. Aims: This study aims to assess neonatal outcome following lumbar epidural analgesia with intermittent boluses of 0.1%
bupivacaine with fentanyl. The secondary objectives included assessment of maternal analgesia, complications, and outcome of labor.
Setting and Design: Prospective observational study conducted at a tertiary care teaching institute. Subjects and Methods: Sixty‑three
patients for labor epidural analgesia were recruited. Epidural catheter was inserted in L4–L5 or L3–L4 interspace. After confirmation of the
position of catheter, 3 mL of 0.5% bupivacaine with 20 µg of fentanyl made to 15 mL was administered. After 30 min, efficacy of analgesia
was assessed by visual analog scale (VAS). The same bolus dose was repeated after 90 min if the patient complained of pain. A maximum of
five top‑up doses were allowed. Statistical Test Used: Mean and standard deviation, number and percentage Results: After 30 min of first
bolus dose, 93.3% had VAS score of <4. More than 90% patients had adequate analgesia till 4th epidural bolus. During contraction stress test,
only two fetuses had late deceleration. About 80% and 98.3% newborns had Apgar of >7 at 1 and 5 min, respectively. Umbilical cord blood
pH was ≥7.1 in 98.3% neonates with base excess of >−12. 58.3% delivered normally, 23.3% had instrumental vaginal delivery, and 18.3%
required cesarean section. Conclusion: Lumbar epidural analgesia with 0.1% bupivacaine with fentanyl provides optimal neonatal outcome,
labor analgesia, and labor outcome.

Keywords: Analgesia, bupivacaine, epidural, fentanyl, labor

Introduction to the effect of anesthetic drugs on the fetus and neonatal


asphyxia.[1]
Labor pain is associated with both maternal and fetal adverse
effects. In the course of normal labor, these stresses are Aim of the study
well tolerated by many healthy parturients with adequate The primary objective of the study was to assess neonatal
uteroplacental perfusion. However, as a consequence of labor outcome following institution of lumbar epidural analgesia with
pain maternal and or fetal decompensation can occur especially 0.1% bupivacaine with fentanyl during labor. The secondary
in the presence of maternal coexisting diseases, uteroplacental objectives included assessment of maternal pain relief (quality of
insufficiency or when the course of labor becomes complicated. analgesia), complications and outcome of labor in terms of
Effective pain relief can alleviate the stress response and normal or assisted vaginal delivery or cesarean section.
improve the outcome in such situations.
The beneficial effects of labor analgesia have been well Address for correspondence: Dr. Sunil Rajan,
documented; at the same time, it is also shown to have few Department of Anaesthesiology, Amrita Institute of Medical Sciences,
Kochi, Kerala, India.
undesirable effects on the course and outcome of the labor
E‑mail: sunilrajan@aims.amrita.edu
as well as on the fetal well‑being. These include increased
incidence of instrumental deliveries, cesarean sections, and
depressed neurobehavioral status in the fetus secondary This is an open access journal, and articles are distributed under the terms of the Creative
Commons Attribution‑NonCommercial‑ShareAlike 4.0 License, which allows others to
Access this article online remix, tweak, and build upon the work non‑commercially, as long as appropriate credit
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How to cite this article: Kesavan R, Rajan S, Kumar L. Effect and safety
DOI: of labor epidural analgesia with intermittent boluses of 0.1% bupivacaine
10.4103/aer.AER_168_18 with fentanyl on fetal and maternal outcomes and wellbeing. Anesth Essays
Res 2018;12:769-73.

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Kesavan, et al.: Bupivacaine with fentanyl provide safe labor analgesia

Subjects and Methods The following maternal complications such as maternal


hypotension, unintentional dural puncture, unexpected high
This was a prospective observational study conducted in
block, motor blockade, pruritus, and headache were looked
63 consecutive patients who had undergone labor epidural
for. Maternal hypotension was defined as a systolic blood
analgesia with specified protocol after obtaining patient consent
pressure  (SBP) <100  mm of Hg or a fall in SBP  >30% of
and clearance from the Institutional Ethical Committee. Three
baseline value. Maternal satisfaction was assessed by asking
patients were excluded from the study due to congenital
the parturient whether she preferred to undergo labor analgesia
anomalies of the fetus. Those with a history of the previous
in the future pregnancy or encourage her relatives or friends
cesarean section, preeclamptic toxemia of pregnancy, fetuses
to prefer epidural analgesia during labor.
with congenital malformations, abnormalities in parturients’
spine, history of psychiatric illness, neurologic illness, twin Continuous variable values were expressed as mean and
pregnancy, and those scheduled for elective cesarean section standard deviation. Categorical variable values were expressed
were excluded from the study. as numbers and percentages.
Those consenting parturients in early labor, as evidenced by
cervical dilatation <5 cm and regular uterine contractions, were Results
inducted in our study. On admission, a full medical, obstetric, The mean age of patients was 27.62  ±  2.94  years. Among
and anesthetic history was taken. This was followed by a detailed 60 patients 38 (63.3%) were primigravidae and 22 (36.7%)
medical and obstetric examination. The preanesthetic evaluation were multigravidae. Mean cervical dilatation at the time of
also included assessment of fetus, which included gestational initiating epidural analgesia was 3.8 ± 1.4 cm.
age, fetal presentation, fetal growth, and fetal well‑being. Basic
The mean VAS for assessment of pain before initiating epidural
investigations such as complete blood count, blood grouping,
analgesia was 8.05 ± 0.69. After 30 min of giving the first bolus
urine routine, and microscopic examinations were done. All
dose, 56 parturients (93.3%) had a VAS score of <4. The mean
parturients were of the American Society of Anesthesiologists
VAS score was 2.08 ± 1.44, which meant adequate pain relief.
physical status Class 2 and either primipara or second gravida.
Fifty‑four patients required second bolus dose of analgesia.
All patients were hydrated with 500 mL of normal saline or The mean VAS score after the second dose of the drug was
Ringer’s lactate. Baseline maternal blood pressure, heart rate 2.43  ±  0.83 and 96.3% had a VAS score of  <4. Thirty‑five
(HR), and fetal HR were recorded. The epidural space was parturients were given the third dose of epidural analgesic, the
identified by the loss of resistance technique. The epidural mean VAS score after the third dose was 2.97 ± 0.57 and 91.4%
catheter was inserted in L4–L5 or L3–L4 interspace and the had a VAS of <4. Fourteen parturients were given the fourth
epidural catheter was threaded 3–4 cm into the epidural space bolus of epidural analgesic; the mean VAS after the fourth dose
before fixing it. was 3.5 and 92.9% of parturients had a VAS score of <4. Four
parturients required fifth epidural bolus of analgesic and the
After confirmation of the position of the catheter, 3 mL of 0.5%
mean VAS score after this was 3.5 ± 0.57 with 50% had a VAS
bupivacaine with 20 µg of fentanyl made to a total volume of
score of <4 and 50% had a VAS of 4 [Figure 1].
15  mL was injected slowly through the catheter  (15  mL of
0.1% bupivacaine and 20 µg fentanyl). Care was taken not to Out of the 60 fetuses, only two had abnormal HR [Table 1].
administer the drug during uterine contractions. Only one had developed bradycardia with a positive contraction
Maternal blood pressure at 10, 20, 30, and 60 min after giving
each bolus dose was documented. Automated oscillatory
noninvasive blood pressure recording was used to minimize
observer bias. Continuous maternal and fetal HR monitoring
were done. Verbal communication with the parturient was
maintained. After 30  min, the efficacy of analgesia was
assessed by visual analog scale (VAS). If there was no pain
relief, the catheter was repositioned or reinserted in another
space if the patient was willing to do so. The patient was cared
for in the lateral position to avoid aortocaval compression.
The intensity of motor blockade was assessed by Bromage scale
30 min after each bolus dose. The same bolus dose was repeated
after 1½ h if the patient complained of pain. A maximum of five
top‑up doses were allowed which would provide analgesia for
about 8 h. The outcome of labor was assessed in terms of normal
vaginal delivery, assisted vaginal delivery, or cesarean section.
Fetal well‑being was assessed by Apgar score at 1 and 5 min
and by pH and base excess of umbilical cord blood. Figure 1: Percentage of patients with visual analogue scale more than 4

770 Anesthesia: Essays and Researches  ¦  Volume 12  ¦  Issue 4  ¦  October-December 2018
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Kesavan, et al.: Bupivacaine with fentanyl provide safe labor analgesia

stress test. During contraction stress test, only two fetuses had 11  cases  (18.3%) required cesarean section. Fifty‑three
late deceleration of HR [Figure 2]. out of 60 (88.3%) parturients were satisfied with the pain
relief obtained by the labor epidural analgesia and expressed
The 1‑min Apgar score was  >7 in 39  (80%) neonates
their willingness for epidural analgesia during the next
and 21  (20%) had an Apgar of  <7 and none of them had
pregnancy.
an Apgar  <5. The 5‑min APGAR was  >7 in 59  (98.3%)
neonates, and it was between 5 and 7 in only one  [1.7%,
Figure  3]. The umbilical cord blood pH was  ≥7.1 in
59  (98.3%) neonates and  <7.1 in 1  (1.67%) neonate. The
cord blood pH was <7.15 in 3 (5%) of neonates. Fifty‑nine
neonates had a cord blood base excess >−12 and only one
had <−12, [Table 2].
Hypotension was not observed in any case [Table 1]. Motor
blockade of the Bromage scale 2 was observed in 4 (6.7%)
cases. High sensory block manifested as numbness of upper
limbs was seen only in one parturient who was of short
stature.There was no respiratory compromise  [Figure  4].
Of the 60 parturients, 35  (58.3%) delivered normally,
14  (23.3%) had instrumental vaginal delivery, and

Table 1: Mean maternal and fetal heart rates Figure 2: Incidence of late deleration
Time Number of Mean Mean FHR
patients maternal SBP
Baseline 60 119.10±10.9 137.70±9.17
After first dose
After 10 min 60 123.45±10.9 137.23±8.25
After 20 min 60 116.32±9.8 136.17±8.81
After 30 min 60 112.72±9.1 136.23±9.79
After 60 min 60 113.18±9.4 135.83±8.41
After second bolus
After 10 min 54 125.1±9.08 135.30±6.84
After 20 min 54 118.7±8.6 135.06±6.67
After 30 min 54 114.7±8.2 132.87±6.65
After 60 min 54 114.0±6.8 135.42±6.23
After third bolus
After 10 min 35 125.70±9.24 133.31±6.56
After 20 min 35 120.71±9.17 135.34±6.56
After 30 min 35 116.34±6.68 135.66±5.63
Figure 3: Apgar at 1 and 5 min
After 60 min 35 115.26±7.35 134.31±6.56
After fourth bolus
After 10 min 14 128.43±11.5 135.14±5.75
After 20 min 14 123.56±9.23 134.21±4.74
After 30 min 14 118.43±8.74 133.71±5.76
After 60 min 14 116.85±7.75 135.29±5.58
SBP=Systolic blood pressure, FHR=Fetal heart rate

Table 2: Umbilical cord blood gas analysis results


Variable Frequency (%) Mean
pH
≥7.1 59 (98.33) 7.28
<7.1 1 (1.67)
<7.15 3 (5)
Base excess
<−12.0 59 (98.3) 4.92
>−12 1 (1.7) Figure 4: Maternal complications

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Kesavan, et al.: Bupivacaine with fentanyl provide safe labor analgesia

Discussion neurobehavioral testing, which are very subjective and lack


specificity. The addition of fentanyl (2 μg/ml) to bupivacaine
Labor is a painful event and for majority of women, it may be
0.125% when used for labor epidural was found to decrease the
the most painful event that she ever experienced. There are
time of onset of analgesia and increase the duration of analgesia
no physiological advantages gained from labor pain. Instead
and level of maternal satisfaction during labor as compared
pain of labor often results in excessive maternal suffering,
to fentanyl  (1 μg/ml).[6] Epidural fentanyl up to 2.5 μg/mL
increased mechanical work, marked maternal hyperventilation
administration does not usually result in either accumulation
and increased oxygen demand. The natural response to the
of the drug or subsequent neonatal respiratory depression.
pain of labor results in rising catecholamine levels leading to
The Apgar score rates the five physical signs and is used to
uterine hypoperfusion, fetal hypoxia, and acidosis.
assess the condition of the infant at birth, but it is not specific
To overcome these maternal and fetal adverse responses to for the effects of anesthesia on the newborn.[7] In our study,
labor pain and also to make childbirth free of pain, various the 1 min Apgar score was found to be <7 in 20% of neonates
methods have been tried. Among these, the analgesia provided whereas none of them had an Apgar <5, which needed active
by epidurally administered local anesthetic agents was found resuscitation. The 5‑min Apgar, which correlates with the
to be superior in terms of maternal pain relief and fetal safety. long‑term neurological outcome, was >7 in 98.3% neonates.
This is evident by the continued increase in the use of this The findings of APGAR scores at 5 min was comparable to
technique over the past 20 years. However, there are concerns studies by Anwar[8] and Antonakou.[9]
regarding the unintended maternal, fetal, and neonatal effects
Cord blood gas analysis is the gold standard for assessing fetal
of epidural analgesia. There is sufficient evidence to conclude
acid-base status and uteroplacental function at birth. Cord
that epidural analgesia is associated with a lower rate of
blood pH and base excess reflect fetal and immediate neonatal
spontaneous vaginal delivery, a higher rate of instrumental
condition. Normal values vary depending on the influence of
vaginal delivery and prolonged labor.[1] Although in the recent
many factors including duration of labor, parity, etc. They are
years, neuraxial analgesia has been recommended as the
also affected by sampling techniques. Preanalytical error can
gold standard for obtaining labor analgesia in the absence of
be introduced if the cord is not clamped immediately, if air is
specific obstetric contraindications,[2,3] concerns regarding its
present in the syringe, or the sample is kept at room temperature
safety and maternal outcome still exist among obstetricians.
for >15 min. The normal umbilical artery pH at term is 7.27
Recent systematic review and meta‑analysis have proved
± 0.07 and base excess is –2.7 ± 2.8 mM/L. Risk of neonatal
that as compared to nonepidural analgesia, epidural analgesia
neurologic morbidity is high only when umbilical arterial pH
with low concentration of local anesthetic did not result in
is below 7.0, 14 or base deficit is above 12 mM/L.[10] Infants
prolonged duration of the second stage of labor or an increased
with pH <7.0 at birth who are not vigorous are at high risk of
instrumental delivery rate.[4]
adverse neurologic outcome.[11]
Neuraxial analgesia techniques and medications provide
Reynolds et  al.[12] have shown that umbilical artery pH is
flexible and effective analgesia during labor with minimal
influenced by maternal hyperventilation. Therefore, the base
motor blockade.[5] Bupivacaine is one of the preferred local
excess is considered as a better index of metabolic acidosis after
anesthetic in labor epidural analgesia because it is highly
labor. Epidural analgesia is associated with improved neonatal
protein bound (94%) and hence has longer duration of action.
acid‑base status which signifies that placental exchange is well
At low concentrations, it produces good sensory blockade
maintained in association with maternal sympathetic blockade
with minimal or no motor blockade. It has minimal placental
and adequate analgesia. Although epidural analgesia may cause
transfer, thereby producing low feto/maternal blood ratio at
maternal hypotension, longer second stage of labor, and more
delivery (0.31–0.44). It does not produce tachyphylaxis. The
instrumental vaginal deliveries, these adverse factors appear to
addition of opioids will allow giving a more dilute solution of
be outweighed by benefits to neonatal acid‑base status. Sharma
local anesthetic to provide excellent analgesia during labor.
et al.[13] in their study evaluated 358 parturients who underwent
Advantages of a decreased total dose of local anesthetic labor epidural analgesia and found that the incidence of cord
include decreased risk of systemic local anesthetic toxicity, blood pH ≤7.20 in 17% of parturients and pH <7.0 in 0.30%
decreased risk of high or total spinal anesthesia, decreased cases. In our study, the umbilical cord blood pH was ≤7.2 in
plasma concentration of local anesthetic in the fetus and 10% neonates and only in 1.7% cases the pH was <7. Regarding
neonate and decreased the intensity of motor block. In our base excess, 98.3% neonates had cord blood base excess >−12
study, only 3.3% had abnormal HR. For one fetus, tachycardia and only 1.7% had<−12.
was present even before initiating epidural analgesia. Only
In our study, none of the parturients developed a high or total
one developed bradycardia with a positive contraction stress
spinal anesthesia. The use of multi‑orifice epidural catheter
test. During contraction stress test, only two fetuses had late
and careful assessment of the patient’s response to the test
deceleration of HR which warranted lower segment cesarean
dose reduce the chance of unintentional administration of a
section. One of it was due to cord around the neck.
large dose of local anesthetic into the subarachnoid space.
The neonatal depressant effects of drugs administered The incidence of hypotension after initiation of neuraxial
intrapartum to mother are commonly assessed with analgesia during labor was found to be approximately

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Kesavan, et al.: Bupivacaine with fentanyl provide safe labor analgesia

14%.[14] In our study, only five patients  (8.5%) developed Financial support and sponsorship
hypotension (SBP < 100 mmHg). The lower incidence could be Nil.
due to preloading with 500 mL of ringer lactate and keeping the
parturient in lateral position to avoid aortocaval compression Conflicts of interest
as well as due to the use of a lower concentration of local There are no conflicts of interest.
anesthetic agent.
Pankaj, et al.[15] had reported a dural puncture incidence of 1% References
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