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187]

Original Article

Efficacy and safety of combined spinal: Epidural

versus epidural technique for labor analgesia in
parturients with rheumatic valvular heart disease
Babita Ghai, Ram Krishnamoorthy, Dipika Bansal1, Vanita Suri2, Rajesh Vijayvergiya3, Jyotsna Wig
Departments of Anaesthesia and Intensive care, 2Obstetrics and Gynaecology, and 3Cardiology, Postgraduate Institute of Medical Education and Research,
Chandigarh, 1Pharmacy Practice, Clinical Research Unit, National Institute of Pharmaceutical Education and Research (NIPER), Mohali, Punjab, India

ABSTRACT
Background: Hemodynamic changes induced by labor pain and apprehension in addition to physiological changes may pose risk to
parturients with rheumatic heart disease (RHD). Therefore, it is important to provide adequate pain relief during labor in these patients.
We planned this study to compare the efficacy and safety of epidural (E) versus combined spinal epidural (CSE) for labor analgesia in
parturients with rheumatic valvular heart disease. Methods: Twenty-five parturients with RHD included in this study were randomized to one
of the two groups E group (n = 12), received 6 mL of 0.0625% bupivacaine with 25 g fentanyl or CSE group (n = 13), received 25 g of
fentanyl with 1.25 mg bupivacaine diluted to 1 mL in subarachnoid space. Afterward, a continuous infusion of 0.1% bupivacaine with 2 g/
mL fentanyl was started at 6-8 mL/h. Primary outcome, analgesic efficacy, was assessed by visual analog scale (VAS) for pain. VAS 3 was
considered as effective analgesia. Rescue analgesia in the form of epidural bolus was given if VAS > 3. Results: Demographic characteristics
of the patients were comparable. Mitral stenosis was the predominant valvular lesion. The VAS at which the parturients received analgesia
was comparable. The mean time to achieve effective analgesia was significantly faster in CSE group (4.46 0.87 min) compared with group
E (15.09 5.7 min) (P < 0.001). Significantly lower median pain scores were recorded until the initial 15 min in CSE group. Afterward,
median VAS for pain was comparable between the groups. VAS for pain was significantly low at all time intervals than baseline in both
the groups. Maternal satisfaction and incidence of cesarean rate and complication were comparable between the groups. Conclusion: Both
epidural and CSE are equally effective and safe for labor analgesia in parturients with rheumatic valvular heart disease. However, CSE
technique provides a faster onset of analgesia.
Key words: Epidural analgesia, combined spinal epidural analgesia, labour analgesia, rheumatic heart disease

Introduction
Rheumatic heart disease (RHD) is still the most common
heart problem in pregnant women in developing
countries,[1,2] accounting for nearly 90% of cardiac disease
in pregnancy.[1] Mitral stenosis being the predominant
rheumatic valvular lesion.[1,3]
Pregnancy results in dramatic changes in the cardiovascular
system.[3] Physiological changes associated with increased
Access this article online

metabolic demands can lead to functional deterioration

in pregnant women with valvular heart diseases.[4] The
time of maximum risk for these patients is during late
pregnancy, labor, and immediately postpartum.[5] During
labor, pain- and apprehension-induced tachycardia may
cause a decrease in cardiac output by reducing diastolic
filling time in the presence of limited flow rate through
stenotic mitral valve.[6,7] Hence, it is particularly important
to avoid pain-induced tachycardia by adequate pain relief.
The available data and evidence on ideal labor analgesia for
parturients with RHD is limited. Carefully and gradually
titrated lumbar epidural or combined spinal epidural

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DOI:
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Address for correspondence:

Dr. Babita Ghai,
Department of Anaesthesia, PGIMER,
Chandigarh - 160 012, India.
E-mail: ghaibabita@hotmail.com
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Ghai, et al.: Combined spinal epidural vs epidural analgesia for parturients with RHD for labour analgesia

(CSE) techniques have been advocated in nearly all

patients.[8]
The ecacy and safety of epidural and CSE techniques for
labor analgesia in normal parturients is well established.[9-12]
When compared, these two techniques are reported to
have varied results. It has been reported that analgesia
initiation through the intrathecal route may improve the
eectiveness of epidural component. Use of CSE technique
is reported to have faster onset eective pain relief from
the time of injection, more first-stage analgesia, fewer
requirement of epidural top-ups,[9] and better quality of
analgesia as compared with epidural.[10] However, overall
maternal satisfaction is reported to be similar despite a
slightly faster onset with CSE technique[11] and similar
overall analgesia.[12]
To the best of our knowledge, only few case reports are
available in literature regarding the use of CSE[5,13] and
epidural techniques[7,14,15] for labor analgesia in parturients
with RHD. There is no comparative trial available for
these two techniques in parturients with RHD. So this
randomized, double-blind pilot study was planned to
compare the ecacy and safety of CSE with epidural
technique for providing labor analgesia in pregnant
patients with RHD. We hypothesised that CSE technique
may provide superior analgesia because of its rapid onset
compared with epidural technique and may provide better
maternal satisfaction.

Materials and Methods

Following institutional ethics committee approval
and written informed consent, 29 pregnant patients
with cephalic, singleton pregnancy greater than 37
weeks gestation with RHD and NYHA class I and II,
who requested labor analgesia, were assessed for study
eligibility. The study was conducted at a teaching tertiary
care hospital in northern India during August 2007 to
October 2008. Patients with cephalopelvic disproportion,
severe mitral stenosis (valve area < 1 cm2), severe pulmonary
arterial hypertension, bleeding diathesis, and any other
contraindication to regional techniques were excluded
from the study.
Analgesia was administered to all patients in active
labor (presence of at least three regular, painful uterine
contractions over 10 min and cervical dilatation > 3 cm)
according to the group allocated by randomization. A
computer-generated random number was obtained (using
block of three) and kept in opaque sealed envelopes. The
envelope was opened by an independent anesthesiologist
Indian Journal of Pain | May-August 2013 | Vol 27 | Issue 2

not involved in the study. Patients were randomized to

either the CSE technique (Group CSE, n = 13) or to the
epidural technique (Group E, n = 12).
Infective endocarditis prophylaxis was given to all patients
before the procedure as our institutional policy. The
patients were allowed oral fluids and liquid diet as per the
institute obstetricians protocol.
In both the groups, intravenous access was secured and
no preloading was done.[6,11,16] Patients were placed in the
left lateral position. In group E, the lumbar epidural space
(L3-L4 or L4-L5) was identified by using a loss of resistance
technique with 18G Touhy needle. An epidural catheter
was introduced and secured. In Group CSE (n=13), a
27G, Whitacre needle was inserted into subarachnoid
space through the epidural Touhy needle using a needle
through needle technique. A bolus of 25 mcg fentanyl with
1.25 mg of bupivacaine diluted to 1 mL was administered
intrathecally. An epidural catheter was then introduced
and secured.
The investigator performing the procedure was not
involved in further evaluation of the patient. One
anesthesiologist (not involved in the study but involved in
the clinical management of patient) administered initial
bolus of 6 mL of 0.0625% bupivacaine with 25 mcg fentanyl
in group E and sham bolus of normal saline in CSE group
over 10 min after making the patient supine.
In both the groups, 30 min from the initiation of procedure,
a continuous infusion of 0.1% bupivacaine with 2 mcg/mL
fentanyl was started at 6-8 mL/h.
Severity of labor pain was assessed by a 10 cm long marked
visual analog scale (VAS) with 0 representing no pain and
10 as worst pain. Motor power was assessed by modified
Bromage score and sedation was assessed using a sixpoint Ramsay sedation score. VAS 3 was considered
as eective analgesia. All parameters were monitored
regularly and recorded every 5 min till 30 min then at
60 min and afterward every hourly till delivery. If VAS
was > 3 between 15 and 30 min after starting the infusion,
then 4 mL of 0.1% bupivacaine alone was administered
through epidural catheter. If VAS was >3 between 30 min
and 2 h of starting infusion, 15 mcg of fentanyl diluted to
4 mL with normal saline was given. If VAS was >3 after 2 h
of starting infusion, 25 mcg fentanyl diluted to 4 mL with
normal saline was administered.
The primary outcome was the analgesic ecacy, defined as
VAS 3. Secondary outcomes such as dermatome level of
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Ghai, et al.: Combined spinal epidural vs epidural analgesia for parturients with RHD for labour analgesia

analgesia, heart rate, electrocardiography, blood pressure,

pulse oximetry, pain score, motor power, sedation, and fetal
heart rate. Duration of the first and second stage, mode
of delivery, and the indication for cesarean section was
recorded. Neonatal evaluation was done by Apgar score at
1 and 5 min and cord pH. Maternal satisfaction was recorded
on a four-point scale, that is, excellent, good, fair, and bad.
As an institutional protocol for parturients with heart
disease, an assisted instrumental delivery using either the
forceps or vacuum was planned in all patients.
As there is no prospective, randomized controlled trial
available in the literature for the comparison of these two
techniques for labor analgesia in patients with RHD, this
trial was planned as a pilot study. Data were expressed
as mean SD or median (range). Nominal data between
the two groups were compared using Fischers exact test.
Continuous data such as age, weight, height, period of
gestation, duration of labor were analyzed using Mann
Whitney U test between the two groups. Hemodynamic
data and repeated ordinal data (VAS for pain, sedation score,
and modified Bromage score) were analyzed using twoway repeated measures analysis of variance. If it was found
significant, Freidman test was used for within-group analysis
and Mann Whitney U test was used for between-group
analyses. A value of P < 0.05 was considered significant.

Results
Twenty-nine patients were assessed for eligibility. Four
patients refused consent to participate in the study. Hence,
25 patients were included in this study; 13 in the group CSE
and 12 in the group E [Figure 1]. No technical diculty

was encountered in any patients. The demographic

characteristics of the patients were comparable between
the groups [Table 1].
All patients had mitral valve involvement, mitral stenosis
being the predominant lesion. The severity of mitral
stenosis (mild or moderate) and the NYHA status of
the patients were comparable [Table 2]. In addition to
stenotic involvement of mitral valve, 10 patients (six in
group E and four in group CSE) had mild to moderate
mitral regurgitation, four patients (three in CSE group
and one in group E) had associated mitral and tricuspid
regurgitation, one patient (group E) had associated aortic
regurgitation and one patient (group CSE) had regurgitant
lesion involving mitral, tricuspid, and aortic valves.
Median VAS for pain before initiation of analgesia in CSE
group and group E was 5 (range 4-7) and 5 (range 4-8),
respectively. The VAS at which the parturients received
analgesia was comparable [Table 3].
Table 1: Demographic characteristics of parturients in both the
groups
Parameters
Group CSE
Group E
P
Age (years)
Weight (kg)
Height (cm)
Gravidity
Gestational age (days)
Supervised pregnancy,
Number (%)
Type of labor
Spontaneous: Number (%)
Induced: Number (%)

(n=13)
(n=12)
25 (21-36)
25 (21-32)
52 (45-75)
56.5 (40-67)
155 (145-161) 154.0 (145-165)
2 (1-4)
1.83 (1-4)
266 (259-277) 266 (259-282)
10 (76.9)
8 (66.7)

10 (76.9)
3 (23.1)

7 (58.3)
5 (41.7)

value
0.978
0.494
0.721
0.544
0.190
0.673

0.973

Data is presented as median (range) or number (percentage).

29 pregnant patients with RHD were assessed for eligibility criteria

Excluded (n = 4),
refused consent,
declined to participate
Randomized (n = 25)

Allocated to combined-spinal
epidural group, n = 13 Received
bolus of 25 mcg fentanyl with
1.25 mg of bupivacaine diluted
to one ml intrathecally

Allocated to epidural group, n = 12

Received initial bolus of 6 ml
of 0.0625% bupivacaine
and 25 mcg fentanyl epidurally

2 patients underwent Cesarian

section; hence second stage
analysis was done for 11 patients

2 patients underwent Cesarian

section; hence second stage
analysis was done for 10 patients

Figure 1: Flow chart of participants. (RHD) rheumatic heart disease

82

Table 2: Cardiac status of the patients

CSE group (n=13)
Number (%)
NYHA class
I
6 (46.2)
II
7 (53.8)
Severity of mitral stenosis
Mild
8 (61.5)
Moderate
5 (38.4)

Epidural group (n=12)

Number (%)

P
value

5 (41.7)
7 (58.3)

0.821

6 (50)
6 (50)

0.56

Table 3: Distribution of visual analog scale (VAS) in women at

initiation of analgesia
VAS
(range)
4-6.9
7-9.9

CSE group (n=13)

Number (%)

Epidural group (n=12)

Number (%)

Total
Number (%)

11 (84.7)
2 (15.3)

10 (83.3)
2 (16.7)

21 (84.0)
4 (16.0)

P = 0.980.

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Ghai, et al.: Combined spinal epidural vs epidural analgesia for parturients with RHD for labour analgesia

The mean time to achieve eective analgesia was significantly

faster in CSE group (4.46 0.87 minutes) compared with
group E (15.09 5.7 min) (P < 0.001). Significantly lower
median VAS for pain were recorded at 5, 10, and 15 min in
the CSE group compared with the group E (P < 0.001). After
15 min, the median VAS for pain was comparable between
the groups. VAS for pain was significantly low at all time
intervals than baseline in both the groups [Figure 2].
The median VAS for pain in the second stage of labor, that
is, 2 (range 2-4) in CSE group and 3 (range 3-5) in group E
was comparable (P = 0.124). A second-stage analysis was
done only for 21 patients as four patients (two in the group
E and two in the CSE group) had cesarean section before
they reached second stage.
Durations of first stage and second stage were comparable
between the groups [Table 4].
No motor blockade was observed in any patient. Three
patients in CSE group (23%) had mild pruritus compared
with none in group E, which was self-limiting (P = 0.22).
None of the patients in both the groups had any other
complications such as sedation, hypotension, motor
weakness, respiratory depression, and atonic postpartum
hemorrhage. One patient in the CSE group had one episode
of vomiting compared with none in group E.

One neonate in this study had Apgar score of 5 at 1 min and

belonged to the CSE group. There was fetal asphyxia in this
case because of cord entangled around the neck for which
emergency cesarean section was done. Resuscitation eorts
with bag and mask followed by intubation and intermittent
positive pressure ventilation improved the respiration in
this neonate. The child was subsequently extubated and
Apgar score at 5 min was 8. The umbilical cord pH in the
neonate who had a low Apgar score at 1 min was 6.88. All
other neonates had a cord pH of >7.2.
One patient in the CSE group (7.7%) and three patients in
group E (25%) required additional boluses of bupivacaine
for pain relief. Out of these four patients, one patient in
the CSE group and one patient in group E had first stage of
labor lasting for 14 and 13 h, respectively. The patient who
was allocated to CSE group underwent cesarean delivery
because of nonprogress of labor.
The maternal satisfaction following the administration of
analgesia was evaluated following delivery. The maternal
satisfaction was assessed using a 4-point scale and was
found to be comparable. Eleven (84.6%) and two (15.4%)
patients reported excellent and good analgesia in CSE
group, respectively. Nine (75%) patients reported excellent
and three (25%) reported good analgesia in group E
(P = 0.694).

Discussion
An important consideration in patients with valvular
heart disease is heart rate control.[6] So, as a part of the
management of patients with valvular heart diseases,
regional techniques for labor analgesia have been advocated
to avoid the deleterious eects of severe pain.[4,6,8]

Figure 2: Median visual analog scale (VAS) for pain over time. 1: CSE
group; 2: Epidural group

Table 4: Duration of first and second stage of labor in women

of both the groups
Parameter
Duration of first stage (h)
Duration of second stage (min)

CSE group
8.5 (2.3)
n=13
46 (7.7)
n=11

Epidural group
8.6 (3.2)
n=12
50 (7.8)
n=10

Data were presented as mean (SD), P > 0.05.

Indian Journal of Pain | May-August 2013 | Vol 27 | Issue 2

This study is novel for the reason that it is the first

randomized controlled study comparing CSE and epidural
technique for labor analgesia in parturients with RHD. We
found that both these techniques are eective in providing
labor analgesia. The time to onset of eective analgesia was
significantly faster in the CSE group as compared with group
E. Maternal satisfaction was comparable despite faster onset
of analgesia in CSE group. Incidence of side eect, mode
of delivery, maternal and fetal outcomes were comparable
in both the groups. Similar observation was made by other
authors who also reported a significantly faster onset of
analgesia with the CSE technique in comparison to the
epidural technique.[9-11] On the contrary, Hepner et al[17]
found an early onset of analgesia (2.5 2.2 min) in the
epidural group also which could be attributed to the addition
of sodium bicarbonate to the injectate.
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Ghai, et al.: Combined spinal epidural vs epidural analgesia for parturients with RHD for labour analgesia

With regard to maternal satisfaction, the results of the

present study were consistent with those previously
reported where comparative overall maternal satisfaction
has been reported despite a slightly faster onset with CSE
technique.[11,17]
Regional analgesia by causing sensory blockade may
decrease perineal sensation and obtund the urge to
bear down and may increase the chance of instrumental
delivery. However, in our institute an assisted instrumental
delivery using either the forceps or vacuum is performed
as an institutional protocol for patients with heart disease.
This is done in an attempt to limit maternal Valsalva
maneuvers and stress associated with expulsive eort.[4,5]
Hence we could not study change in mode of delivery with
these techniques.
Fetal bradycardia has been reported after induction of
labor analgesia with intrathecal opioids. Most studies
suggest that incidence of this event is similar with either
intrathecal or epidural labor analgesia.[16,18] We did not
find any dierence in the incidence of fetal bradycardia
between the groups.
In our study, self-limiting pruritus was present in three
cases (23.1%) in the CSE group, which is the most
common side eect reported after intrathecal or epidural
administration of opioids.[9-11]
We administered infective endocarditis prophylaxis to all
patients in our study as our institutional protocol. This was
because our institutional setting is a public funded tertiary
care hospital in a developing country where all clean
and unclean patients are kept in close proximity; hence
the incidence of postdelivery infection in interventional
delivery may be high.

technical and pharmacologic improvements allowing it to

be personalized according to the patients requirements.
It has also been observed that if neuroaxial techniques
are applied carefully, these lead to minimal cardiovascular
complications in cases of vaginal and cesarean section
deliveries as well as labor analgesia in parturients with
symptomatic heart disease.[19] We also did not encounter
any cardiovascular complication in our study in any
group.
The limitation of the study is that this is an exploratory
pilot study of 25 parturients. However, this fact is justifiable
as no prospective randomized controlled clinical trial is
available in the literature for head-to-head comparison
of these two techniques in parturients with RHD. Hence,
sample size calculation was not needed. Further large
clinical trials with adequate sample size are required
to come to a firm conclusion. Significant early onset of
analgesia in CSE technique may form selection criteria to
choose this technique over epidural analgesia.

Conclusion
To conclude, both the methods, that is, CSE and epidural
analgesia are highly effective in providing pain relief
during labor in patients with RHD. With the exception
of a faster onset of eective analgesia, the CSE technique
produced a similar clinical profile to epidural technique.
Hence, eective labor analgesia could be provided by either
CSE or an epidural technique but the administration of
these techniques requires a skilled anesthetic, obstetric,
and cardiology facility, vigilant monitoring, and prompt
intervention.

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How to cite this article: Ghai B, Krishnamoorthy R, Bansal D, Suri
V, Vijayvergiya R, Wig J. Efficacy and safety of combined spinal:
Epidural versus epidural technique for labor analgesia in parturients
with rheumatic valvular heart disease. Indian J Pain 2013;27:80-5.
Source of Support: Nil. Conflict of Interest: None declared.

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