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ORIGINAL ARTICLE
ABSTRACT
1
Assistant Professor; Senior
2
Background: Bupivacaine has been traditionally used as a local anesthetic of choice for
Resident; 3Associate Professor; regional anesthesia and analgesia. Ropivacaine has been marketed in our country with
4
Resident a claim of better motor profile, better safety profile and an equivalent analgesic profile
Department of Anesthesiology, when used in epidurals for postoperative pain. This study aims to compare both drugs
Maharishi Markendeshwar as an epidural infusion in terms of safety, analgesic efficacy by NRS score and patient
Institute of Medical Sciences satisfaction score and motor blockade by modified bromage score in postoperative
& Research, Mullana, Ambala, period.
Haryana 133207, (India)
Methodology: 70 patients of ASA grade I or II, of either sex between the age of 20-
Correspondence: Dr Meghana
Srivastava, Assistant Professor, 65 years, posted for orthopedic lower limb surgery under combined spinal epidural
Department of Anesthesiology, anesthesia were enrolled in this prospective randomised double blind study. The patients
were randomly allocated to one of the two groups; Group 1 patients received 0.125%
Maharishi Markendeshwar
bupivacaine with 2 µg/ml fentanyl, while Group 2 patients received 0.2% ropivacaine,
Institute of Medical Sciences
& Research, Mullana, Ambala,
with 2 µg/ml fentanyl as an adjunct in epidural infusion postoperatively. Epidural infusion
Haryana 133207 (India); was started at the rate of 8 ml/hour after either four hours of administration of spinal
Phone: +8968065509; E-mail: anesthesia or at an NRS score of three, whichever was earlier. We evaluated the NRS
meghana.srivastava.18@gmail. scores, patient satisfaction scores and the need of rescue analgesic. Vital parameters
com and modified bromage score were also registered.
Received: 15 May 2017 Results: The pain score was similar in both groups at different time intervals, except at
Reviewed : 4 Jun, 22 Jun 2017 15 and 30 min after starting epidural infusion, where the pain score was significantly
Corrected: 11 Aug 2017 lower in Group 2 when compared to Group 1 (p-value 0.007, 0.006 respectively). Patient
Accepted : 15 Aug 2017 satisfaction score was significantly more in Group 2 patients. There was no significant
difference in requirement of rescue analgesia in two groups. Modified bromage grade
was statistically more in Group 1.
Conclusion: We conclude that ropivacaine can be used as an alternative to bupivacaine
for postoperative analgesia by epidural infusion, as it provides effective pain control
with the added advantage of lower incidence of motor blockade.
Key words: Postoperative, Analgesia; Analgesia; Epidural; Bupivacaine; Ropivacaine;
Fentanyl
360 ANAESTH, PAIN & INTENSIVE CARE; VOL 21(3) JUL-SEP 2017
original article
ANAESTH, PAIN & INTENSIVE CARE; VOL 21(3) JUL-SEP 2017 361
bupivacaine and ropivacaine in epidural infusion
Table 1: Postoperative NRS and rescue analgesia California and San Francisco
(UCSF; website: www.sample-
NRS Epidural infusion rate (ml/h) Rescue analgesic
size.net). Based on previous
0-1 8 - similar study10 done, the
2-3 8 epidural top-up of 4 ml expected motor blockade was
4-6 10-12 epidural top-up of 4 ml determined (P0 and P1). The
epidural top-up of 4 ml + sample size was calculated
7 and above 12
iv tramadol 100 mg slowly with α-error of 0.05 and power
NRS= numeric rating scale 0-10; 0-no pain and 10-worst possible pain of study 80%.
For qualitative data Chi-square
Table 2: NRS at different time intervals in group 1 and group 2 test (f > 5) and Fisher’s exact
test (f < 5) were applied.
Group 1 Group 2 Demographics was compared
NRS p-value
N Mean ± SD N Mean ± SD by mean and percentage.
0 min 34 3.38 ± 1.07 35 3.11 ± 1.02 0.292 Quantitative data was
15 min 34 3.41 ± 0.82 34 2.85 ± 0.82 0.007 compared by Student t-test.
p-value < 0.05 was considered
30 min 35 2.54 ± 0.89 31 1.97 ± 0.75 0.006
as significant. Software used to
45 min 31 1.52 ± 0.68 20 1.25 ± 0.55 0.148 analyze and compute data was
1H 10 1.30 ± 0.68 4 1.00 ± 0.00 0.403 SPSS version 17.
2h 7 1.00 ± 0.00 2 1.00 ± 0.00 0.896
RESULTS
4h 7 1.86 ± 1.46 3 2.00 ± 1.73 0.743
Both groups were comparable
8H 9 2.11 ± 1.69 7 1.86 ± 1.22 0.592
in age and sex distribution
12 h 11 1.64 ± 1.21 6 1.33 ± 0.82 0.342 (p-value 0.89 & 0.63
16 h 11 1.64 ± 1.21 9 2.22 ± 1.48 0.937 respectively). As shown in
20 h 10 2.70 ± 2.26 11 2.64 ± 1.29 0.724 Table 2, the NRS score was
24 h 12 2.83 ± 1.75 12 2.58 ± 1.68 0.686 similar in Group 1 and Group
2 patients at different time
28 h 15 1.67 ± 1.11 8 1.88 ± 1.25 0.283
intervals, except at 15 min
32 h 13 1.92 ± 1.61 4 3.00 ± 2.00 0.833 and 30 min where the pain
36 h 10 2.20 ± 1.81 5 2.00 ± 1.41 0.632 score was significantly lower
40 h 12 1.92 ± 1.38 9 2.22 ± 1.48 0.769 in Group 2 when compared
44 h 13 1.15 ± 0.38 0 0.00 ± 0.00 — to Group 1 (p-value 0.007,
0.006 respectively). Clinically
48 h 12 1.08 ± 0.29 0 0.00 ± 0.00 —
and statistically both drugs
NRS= numeric rating scale 0-10; 0-no pain and 10-worst possible pain, SD- standard deviation,
provided comparable analgesia.
p-value < 0.05 is significant
A statistically significant
of epidural infusion solution according to the group difference in patient
allocated, and/or tramadol 100 mg IV with antiemetic satisfaction score was observed in Group 2.
prophylaxis with ondansetron 4 mg. Thus, patients receiving ropivacaine infusion
postoperatively had a higher satisfaction score (7.94
Any side effects, e.g. hypotension, pruritus or urinary ± 1.37 vs. 8.66 ± 1.19, p = 0.023)
retention, were noted and treated accordingly.
Hypotension, defined as SBP ≤ 90 or DBP ≤ 60 As shown in Table 3, there was no significant
mmHg, was treated by 3 mg ephedrine and bolus of difference in requirement of rescue analgesia in form
250 ml ringer lactate, also the epidural infusion rate of epidural top-up in Group 1 and Group 2. There
was decreased by 2 ml/h to a minimum of 6 ml/h. The was no incidence of NRS 7 or more in either group,
epidural catheter was removed at the end of 48 h and hence no patient was given intravenous analgesia in
patient's satisfaction score of 1 to 10 was recorded. the form of diclofenac or tramadol.
Statistical analysis: The sample size for the study The incidence of motor blockade was more in
was calculated from the formula provided by Training Group 1 as compared to Group 2 and the difference
for Clinical Research Program at University of was statistically significant. Neither of the groups
362 ANAESTH, PAIN & INTENSIVE CARE; VOL 21(3) JUL-SEP 2017
original article
demonstrated motor blockade Table 3: Requirement of rescue analgesia in group 1 and group 2
of grade 3 (Table 4).
Rescue Group 1 Group 2
p-value
Patient's baseline parameters analgesia Frequency % Frequency %
were recorded and after 0 min 12 34% 12 34% 1.000
starting epidural infusion
15 min 4 11% 0 0% 0.114
vitals including HR, SBP,
DBP were measured at regular 30 min 1 3% 1 3% 1.000
intervals. No significant 45 min 0 0% 0 0% -
hemodynamic changes were 1h 0 0% 0 0% -
observed in either group. 2h 0 0% 0 0% -
DISCUSSION 4h 2 6% 1 3% 1.000
“It is easier to find men who 8h 3 9% 3 9% 1.000
will volunteer to die, than to 12 h 3 6% 1 3% 0.498
find those who are willing to 16 h 3 9% 5 14% 0.710
endure pain with patience” - 20 h 4 11% 8 23% 0.342
Julius Caesar. Postoperative
24 h 7 20% 7 20% 1.000
pain management is essential
for early ambulation and 28 h 5 14% 3 9% 0.710
recovery of the patient. 32 h 3 9% 4 11% 1.000
Inadequate postoperative 36 h 5 14% 2 6% 0.428
pain management can lead to 40 h 5 14% 5 14% 1.000
multiple complications such
44 h 2 6% 0 0% 0.493
as pulmonary, circulatory or
urinary dysfunction as well 48 h 0 0% 0 0% -
as deranged psychological p-value < 0.05 is significant
and emotional behavior.
Epidural analgesia with local
anesthetics is one of the most Table 4: Overall incidence of motor blockade
effective techniques used
Group 1 (n=35) Group 2 (n=35)
for postoperative pain relief MBS p-value
and may improve patient Frequency % Frequency %
outcome.11 Ropivacaine is a
1 12 34.3% 5 14.3% 0.001
long acting local anesthetic,
used in clinical practice since 2 6 17.1% 2 5.7% 0.259
1996. By virtue of its pure S MBS= modified bromage score; p-value < 0.05 is significant
enantiomer form, it is less
cardiotoxic than bupivacaine.
Also, it is less potent,12,13 and hence, the motor form of epidural top up was similar in both groups.
blocking feature of ropivacaine is less intense and of Sara Korula et al,7 compared ropivacaine 0.2% and
lesser duration.11 Finding the balance between motor bupivacaine 0.125% for epidural analgesia following
block and analgesia is the major challenge in epidural bilateral inguinal mesh hernioplasty and concluded
analgesia. that sensory profile was similar in both groups.
Muldoon et al,14 in their study concluded that VAS
In this study, the quality of postoperative analgesia score was more in ropivacaine group when compared
in both groups was good. A similar degree of pain to bupivacaine. Our study results were in accordance
relief was observed in both groups except at 15 to the study conducted by Sara Korula et al.7 This
and 30 min after starting epidural infusion, where could be due to the comparison of same concentration
the NRS was lower in Group 2 than Group 1 and of the two drugs. Contradictory results to our study
the difference was statistically significant. After was found in study conducted by Surabathuni S
30 min the NRS was similar in both groups. None et al15. They concluded that visual analogue scale
of the patients reported NRS of seven or more and, showed significant difference in patients receiving
therefore, intravenous analgesia was not prescribed ropivacaine, having higher VAS score at 1 h ( p =
to any patient. The need for rescue analgesia in the 0.0126), 12 h ( p = 0.0311) and 24 h ( p = 0.042) after
ANAESTH, PAIN & INTENSIVE CARE; VOL 21(3) JUL-SEP 2017 363
bupivacaine and ropivacaine in epidural infusion
the commencement of epidural infusion as compared The baseline vital parameters were comparable in
to bupivacaine. both groups. After the epidural infusion was started
the drop in heart rate was comparable in both groups
The patient satisfaction score was more in Group
but the drop in blood pressure was more in Group 1.
2 when compared to Group 1 in our study (p-value
0.023). Our study results showed similar rate The maximum drop in the blood pressure was in the
of epidural infusion in both the groups and the first hour of starting of epidural infusion following
difference being statistically non-significant. Rescue which the vital parameters were maintained near
analgesia in form of IV analgesics was not required in constant.
either group. This was in accordance with the study Since varying results are observed for efficacy of two
conducted by Korula et al.7 drugs, when compared with other previous studies,
The present study results showed higher incidence of a larger sample size would be required for validation
motor blockade in Group 1 when compared to Group of the results. Small sample size probably is the
2. None of the patients reported MBS more than two limitation of our study.
in any group. Twelve patients in Group 1 reported a CONCLUSION
motor blockade of MBS 1 while the incidence was
limited to five patients in Group 2. Brodner et al.16 From our study we conclude that ropivacaine provides
deduced in their study that MBS more than zero was comparable postoperative pain control by epidural
found only in bupivacaine group. In addition to it, infusion as bupivacaine, with the added advantage
postoperative mobilization was restored earlier in of lower incidence of motor blockade and enhanced
the patients receiving epidural ropivacaine. Finegold patient satisfaction score.
et al.10 in their study compared ropivacaine 0.1% Conflict of interest: None declared by the authors
with fentanyl and bupivacaine 0.125% with fentanyl
infusion for epidural labor analgesia and concluded Authors’ Contribution:
that ropivacaine was associated with less motor MS, MS: manuscript editing
blockade. The outcome of both of the studies were in GA: conduct of study
accordance with our study results. PK, KB: literature search
364 ANAESTH, PAIN & INTENSIVE CARE; VOL 21(3) JUL-SEP 2017
original article
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