Jain R, Gupta P, Jain V.

A comparison of ropivacaine with fentanyl to bupivacaine with fentanyl for post-operative patient
controlled epidural analgesia in patients undergone lower abdominal cancer surgery. IAIM, 2016; 3(7): 137-149.

Original Research Article

A comparison of ropivacaine with fentanyl

to bupivacaine with fentanyl for post-
operative patient controlled epidural
analgesia in patients undergone lower
abdominal cancer surgery
Rashmi Jain1, Pushpalata Gupta2, Vinita Jain3*
1
DNB Anesthesia, Senior Resident, PBM Hospital and SP Medical College, Bikaner, Rajasthan, India
2
Senior Consultant, Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, Rajasthan,
India
3
Consultant, Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, Rajasthan, India
*
Corresponding author email: [email protected]

International Archives of Integrated Medicine, Vol. 3, Issue 7, July, 2016.

Copy right © 2016, IAIM, All Rights Reserved.
Available online at http://iaimjournal.com/
ISSN: 2394-0026 (P) ISSN: 2394-0034 (O)
Received on: 20-06-2016 Accepted on: 30-06-2016
Source of support: Nil Conflict of interest: None declared.
How to cite this article: Jain R, Gupta P, Jain V. A comparison of ropivacaine with fentanyl to
bupivacaine with fentanyl for post-operative patient controlled epidural analgesia in patients
undergone lower abdominal cancer surgery. IAIM, 2016; 3(7): 137-149.

Abstract
Background: PCEA (patient controlled epidural analgesia) is a safe and effective technique for post-
operative analgesia on routine surgical wards. Use of the epidural catheter as part of a combined
epidural-general anesthetic technique results in less pain and faster patient recovery immediately after
surgery than general anesthesia followed by systemic opioids does.
Aim: In this prospective, randomized, double – blind study, we compared the analgesic effectiveness,
hemodynamic changes and other side effects of epidural analgesia with drug combination –
bupivacaine with fentanyl and ropivacaine with fentanyl in different concentrations.
Material and methods: It was a prospective, randomized, double – blind study. Sixty patients of
ASA I-II and age group 18-65 years divided in four groups 15 patients in each group (Group B1
bupivacaine 0.1%; Group B2 bupivacaine 0.05%; Group R1 ropivacaine 0.1%; Group R2 ropivacaine
0.05% with fentanyl 5micrograms/ml in each groups). After taking consent from patients epidural
catheter was placed and study drugs were given to every patient. Visual analogue scale, heart rate,

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Jain R, Gupta P, Jain V. A comparison of ropivacaine with fentanyl to bupivacaine with fentanyl for post-operative patient
controlled epidural analgesia in patients undergone lower abdominal cancer surgery. IAIM, 2016; 3(7): 137-149.

blood pressure, sedation score, modified bromage scale and other side effects were noted for the next
48 hours. Statistical analysis was done by using Medcalc 12.2.1.0 version statistical analysis software.
Results: All four groups were comparable in terms of analgesia but group B1 patients had significant
decrease in blood pressure at all time intervals. This group also had loss in motor power of lower
extremity p value 0.020 than all other three groups.
Conclusions: We concluded that ropivacaine 0.1% with fentanyl 5 µg/mL after major abdominal
surgery provides optimal dynamic analgesia without significant adverse effects.

Key words
Patient controlled epidural analgesia (PCEA), Ropivacaine, Bupivacaine, Fentanyl, Visual analogue
scale (VAS).

Introduction outcomes (e.g., quality of life). Patients whose

The goal of analgesia is to achieve analgesia at pain is controlled in the early postoperative
rest as well as on movement, at the same time period (especially with the use of continuous
minimizing the side effects of analgesics. Use of epidural or peripheral catheter techniques) may
the epidural catheter as part of a combined be able to actively participate in postoperative
epidural-general anesthetic technique results in rehabilitation, which may improve short- and
less pain and faster patient recovery immediately long-term recovery after surgery [2]. Optimizing
after surgery than general anesthesia followed by treatment of acute postoperative pain can
systemic opioids does [1]. improve HRQL [4].

The use of continuous epidural or peripheral Materials and methods

catheter techniques may be able to actively It was a prospective, randomized, double – blind
participate in postoperative rehabilitation, which study. Randomization is done by sealed envelope
may improve short- and long-term recovery after technique. Blinding Technique – Observers who
surgery [2]. recorded the data i.e. pain and motor scores were
blinded with respect to patient’s group allocation.
The pharmacodynamic profile of ropivacaine The observers were never be anesthesiologist
was reported to be superior to that of providing clinical care to the patient.
bupivacaine, especially in clinical settings where
early ambulation is required. Therefore, we We included 60 patients of age between 18 yrs to
conducted this study to evaluate the efficacy of 65 yrs, ASA physical status I and II, weight 40 –
different concentrations of ropivacaine with 100 kg, lower abdominal surgery and patients
fentanyl for postoperative patient controlled who can be explained and was able to use patient
epidural analgesia as compare to bupivacaine controlled analgesia effectively.
with fentanyl, to assess the safety of use of
epidural ropivacaine with fentanyl as compare to Patients with history of allergy to amide local
bupivacaine with fentanyl and to test the anesthetic and fentanyl, chronic opioid use,
hypothesis that epidural ropivacaine produces chronic alcoholic, motor disorders of lower limb
less cardio toxicity, less neurotoxicity and less and inability to comprehend or perform verbal or
motor block than bupivacaine. physical assessments were excluded from the
study.
The intensity of acute postoperative pain is a
significant predictor of chronic postoperative After taking Institutional Ethics Committee
pain [3]. Control of acute postoperative pain may approval and informed consent from all 60
improve long-term recovery or patient-reported patients undergoing lower abdominal surgery

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Jain R, Gupta P, Jain V. A comparison of ropivacaine with fentanyl to bupivacaine with fentanyl for post-operative patient
controlled epidural analgesia in patients undergone lower abdominal cancer surgery. IAIM, 2016; 3(7): 137-149.

including wertheim’s hysterectomy, low anterior Additional muscle relaxation was administered
resection and retroperitoneal lymph node as required. IV opioid supplementation was
dissection were randomly divided into restricted to i.v. fentanyl during intra-operative
Bupivacaine 0.1% with fentanyl 5 µg/ml (Group period. During intra-operative period if patients
B1); Bupivacaine 0.05% with fentanyl 5 µg /ml developed hypotension (systolic pressure ≤90
(Group B2); Ropivacaine 0.1% with fentanyl 5 mm Hg and 20% below baseline systolic blood
µg/ml (Group R1); Ropivacaine 0.05% with pressure) then it was treated with mephentermine
fentanyl 5 µg/ml (Group R2). (vasopressor).

We explained each patient regarding use of On admission to the post anesthesia care unit,
patient controlled analgesia (PCA) device during patients received a standard teaching regarding
the preanesthetic check up. An anesthesiologist use of the PCEA device. The standard settings
who was not one of the observers prepared include a fixed bolus of 2 mL of study solution,
solutions of the study drug according to group 15 min lockout time and a background infusion
allocation. of 5 mL/h. Patients with inadequate analgesia
(visual analogue scores (VAS) for pain at rest
A baseline assessment of vital signs, pain, >3/10) received a 4mL bolus of study drug and a
nausea, pruritus, sedation scores and lower- 2 mL/h increase in the rate of infusion and then
extremity motor strength was performed on all reassessment was done in 20 min. The same
patients in a preoperative holding area. All intervention was repeated until patients reported
patients received a standard premedication of a VAS at rest <3/10 upto maximum of 13
midazolam (≤0.02-0.04 mg/kg) and/ or fentanyl ml/hour. All patients received paracetamol 1 g
(≤1 μg/kg) IV before placement of an epidural every 6 hourly either orally, via a nasogastric
catheter 4–6 cm into the epidural vertebral tube, or rectally. All patients received injection
interspaces. A 3-mL 2% lidocaine test dose Ondansetron 4 mg IV 8 hourly for three days.
containing 15 μg epinephrine was given from the Patients were transferred to standard nursing care
catheter. If no intrathecal or intravascular on the hospital ward when standard post
injection was evident 5 min later a further 10 mL anesthesia care unit discharge criteria were met.
of 1% lidocaine with epinephrine 1 in 200000 is Inadequate analgesia in hospital ward was treated
dosed. Sensory block (to cold) covering the area as described above. The nursing team was
of the proposed incision (T10) was confirmed instructed to call an anesthesiologist to assess the
before surgery. An additional 5 mL of 1% patient if more than two increases in the infusion
lidocaine with epinephrine 1 in 200000 was rate for inadequate analgesia were required, if
given if an adequate block is not demonstrated motor block develops, if patients develops
by 15 min. After sensory blockade was hypotension (systolic pressure ≤90 mm Hg and
substantiated, patients were randomized in a 20% below baseline systolic blood pressure) or
double-blinded manner by an anesthetist to postural hypotension impairing ambulation.
receive one of four epidural infusions: according Hypotension on the ward was treated with a 500-
to group allocated. General anesthesia was mL bolus of normal saline. In addition, for
achieved with propofol (2-2.5 mg/kg), fentanyl hypotension or for motor-block impairing
(≤2 μg/kg) and muscle relaxation at the ambulation, the infusion was held for 1 h then
discretion of the primary anesthesia team. After 1 restarted lower hourly rate. If inadequate pain
h of induction, the epidural infusion with the relief because of unilateral block is suspected, or
blinded solution was commenced at 5mL/h after if unilateral motor block is assessed, the epidural
a bolus of 5ml of the study solution. catheter was withdrawn 1 cm from the epidural
space or the catheter is replaced. For interim
General anesthesia was maintained with treatment of inadequate analgesia, fentanyl IV
isoflurane in 60% nitrous oxide and 40% oxygen. will be administered. No other analgesics,

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Jain R, Gupta P, Jain V. A comparison of ropivacaine with fentanyl to bupivacaine with fentanyl for post-operative patient
controlled epidural analgesia in patients undergone lower abdominal cancer surgery. IAIM, 2016; 3(7): 137-149.

including nonsteroidal anti-inflammatory drugs inability to do so. All other aspects of care were
(NSAIDs), were administered during the infusion left to the patient’s own clinicians. The duration
of the study drug. If analgesia was inadequate of surgery was also noted. Specific daily patient
with the infusion rate at 13mL/h and the patient questioning include quality of analgesia (1 =
had received two additional 4-mL bolus doses at poor, 2 = fair, 3 = good, 4 = excellent), the
least 30 min apart, the case was considered as an presence of pruritus or nausea as an index of
“efficacy failure,” and alternate analgesia was recovery and all adverse events were recorded.
provided.
Sample size was calculated at 80% of study
All patients were assessed by a blinded power, alpha (α) error of 0.05 and beta (β) error
investigator for 1hour after completion of of 0.2 assuming standard deviation of 1.5 in VAS
surgery to assure adequate analgesia, proper score immediately after shifting the patient. For
equipment function, and stable vital signs and minimum detectable difference of 2 in VAS
then every 4 hourly till 24 hours and then every 6 score sample size required comes to 14 patients
hourly till next 24 hours. In addition to the in each group. This was further enhanced to 15
preoperative baseline assessment, patients patients in each group considering dropout or
underwent subsequent assessments for motor attrition due to adverse reactions,
functions (modified Bromage scale) three times hypersensitivity reactions and other effects. Chi –
in a day for first 48 hours in postoperative period square test was used for demographic variables
morning (7 A.M. – 9 A.M.) afternoon 2 P.M. – 4 and for comparative study of all four study
P.M and night 7 P.M. to 9 P.M. Study groups one way AnoVA test was applied on
measurements includes the following: blood observation tables summarized as mean(SD) or
pressure and heart rate; pain scores at rest, with as percentages. The statistical analysis was
coughing and with mobilization (supine to carried out using Medcalc 12.2.1.0 version
standing), and with lower-extremity motor (MedCalc Software Mariakerke, Belgium). P
function assessments ( modified Bromage Scale), value < 0.05 was considered statistically
pruritus and nausea scores (VAS 0–10 scale); significant.
observer-rated sedation score 0–4 (0 = no
sedation, 1 = mildly sedated, 2 = sleeping but Results
easily aroused, 3 = sleeping but difficult to Demographic variables age, sex, ASA grade, and
arouse, 4 = not arousable); and ability to weight did not differ significantly among the four
ambulate (yes/no). For occurrence measurements groups respective Tables - 1, 2, 3, and 4. No
pruritus and nausea were considered to be patients were excluded from the study.
present if VAS >5. Side effects were considered Hemodynamic data were as per Graphs - 1, 2, 3,
clinically significant if they persist for two and 4. Pulse rate was not significantly different
consecutive measurement periods despite in all the four groups at all the time intervals
adjustments to the analgesic regimen as (Graph - 1). SBP was significantly low in group
described above. B1 at all time intervals after start of study
solution from all other three groups except for
Pain was measured using a visual analog scale immediately after shifting the patient (p value
(VAS) (0 = no pain, 10 cm = worst pain 0.096) (Graph - 2). DBP was significantly low
imaginable). Motor block was measured using in group B1 patients except for the five minute (p
the modified Bromage scale [5] (0 = no motor value 0.266), sixty minute (p value 0.093) and at
block, 1 = inability to raise extended leg, 2 = fourty eight hours (p value 0.347) after start of
inability to flex knee, 3 = inability to flex ankle). study solution (Graph - 3). MBP was also
Twice daily mobilization (walking bed to chair) significantly low in group B1 patients at all time
was encouraged and the VAS score was recorded intervals (Graph - 4).
and if patients were unable, the reason for

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controlled epidural analgesia in patients undergone lower abdominal cancer surgery. IAIM, 2016; 3(7): 137-149.

Graph – 1

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Jain R, Gupta P, Jain V. A comparison of ropivacaine with fentanyl to bupivacaine with fentanyl for post-operative patient
controlled epidural analgesia in patients undergone lower abdominal cancer surgery. IAIM, 2016; 3(7): 137-149.

Graph – 2

Graph - 3

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Jain R, Gupta P, Jain V. A comparison of ropivacaine with fentanyl to bupivacaine with fentanyl for post-operative patient
controlled epidural analgesia in patients undergone lower abdominal cancer surgery. IAIM, 2016; 3(7): 137-149.

Graph – 4

Patients in all the four groups experienced Pain at cough was significantly different at eight
adequate pain relief during the 48 hours after hours (p value 0.000), sixteen hours (p value
surgery, but pain score at rest was significantly 0.000), twenty four hours (p value 0.043) and
different at immediately shifting the patient (p thirty six hours (p value 0.013) with minimum
value 0.000), twenty minutes (0.000), fourty pain score in group R1 and maximum pain score
minutes (p value 0.013), Four hours (p value in group B2 (Graph - 6).
0.081), twelve hours (p value 0.010), sixteen
hours (p value 0.012), twenty hours (p value Pain score at movement from supine to sitting
0.021), twenty four hours (p value 0.001) in first was significantly different at four hours (p value
24 hours with maximum pain relief in group R1 0.003), sixteen hours (p value 0.021) and twenty
and minimum pain relief in group B2 at all time four hours (p value 0.029) with minimum pain
intervals, but it was not significantly different score in group R1 and maximum pain score in
after twenty four hours in all the four groups group B2 but it was not significantly different
(Graph - 5). after twenty four hours in all the four groups
(Graph - 7).

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Jain R, Gupta P, Jain V. A comparison of ropivacaine with fentanyl to bupivacaine with fentanyl for post-operative patient
controlled epidural analgesia in patients undergone lower abdominal cancer surgery. IAIM, 2016; 3(7): 137-149.

Post-operative nausea vomiting, sedation score three groups on all three days of observation
and total volume of study solution used and (Table - 5). The total volume of study solution
patient satisfaction were not statistically different used was minimum for group R1 patients and
in all the four groups. None of the patient had maximum for group R2, and it was statistically
complained of pruritus for all three PODS. significant after 48 hours (p value 0.022) (Table
- 6).
All the patients had indwelling urinary catheter
for three days. Therefore, urinary retention as Overall patient satisfaction concerning the pain
side effect could not be evaluated. management regimen was good to excellent in all
the four groups. There is no statistically
Motor power loss was significantly high (p value significant difference between all the four groups
0.020) in group B1 as compare to all the other (p value 0.659) (Table - 7).

Graph – 5

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controlled epidural analgesia in patients undergone lower abdominal cancer surgery. IAIM, 2016; 3(7): 137-149.

Graph – 6

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Jain R, Gupta P, Jain V. A comparison of ropivacaine with fentanyl to bupivacaine with fentanyl for post-operative patient
controlled epidural analgesia in patients undergone lower abdominal cancer surgery. IAIM, 2016; 3(7): 137-149.

Graph – 7

Discussion postoperative patient controlled epidural

After institutional Ethics Committee approval analgesia with bupivacaine and fentanyl.
study was conducted in a tertiary care cancer
centre from May 2010 to May 2012. Sixty Continuous epidural infusion of a local
patients of age group 18-65 years and ASA grade anesthetic-opioid combination provide analgesia
I–II undergoing lower abdominal cancer surgery superior to that of intravenous PCA with opioids
such as wertheim’s hysterectomy, low anterior [6] and also decreases postoperative pulmonary
resection and retroperitoneal lymph node complications in patients undergoing abdominal
dissection were included in our study. Patients and thoracic surgeries [7]. Use of a continuous or
with history of allergy to amide local anesthetic background infusion in addition to the demand
or fentanyl, h/o chronic opioid use, or any motor dose is more common with PCEA than with
disorder of lower limb were excluded. intravenous PCA and may provide analgesia
superior to that with the use of a demand dose
Good pain control in the postoperative period has alone [8].
a role in improving the surgical outcome with
reduced morbidity and mortality, and there is a Patients in all the four groups experienced
common consensus that optimal dynamic pain adequate pain relief during the 48 hours after
relief is a prerequisite for early postoperative surgery, but pain score at rest was significantly
recovery. This is more important in cancer different at immediately shifting the patient (p
patients who are physiologicaly and value 0.000), twenty minutes (0.000), forty
psychologically more comprised. Surgeries are minutes (p value 0.013), four hours (p value
more intense with lymph node dissection which 0.081), twelve hours (p value 0.010), sixteen
causes more pain, often needs i.v. opioids in high hours (p value 0.012), twenty hours (p value
doses that can cause sedation and respiratory 0.021), twenty four hours (p value 0.001) in first
depression. This delays patient’s ambulation and 24 hours with maximum pain relief in group R1
recovery. and minimum pain relief in group B2 at all time
intervals, but it was not significantly different
In our study, we compared different after twenty four hours in all the four. Our all
concentrations of ropivacaine with fentanyl for patients had good pain scores (<4 on POD1) with
least sedation scores were able to sit in bed on

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Jain R, Gupta P, Jain V. A comparison of ropivacaine with fentanyl to bupivacaine with fentanyl for post-operative patient
controlled epidural analgesia in patients undergone lower abdominal cancer surgery. IAIM, 2016; 3(7): 137-149.

very next day morning and were able to do We assessed the motor power by modified
spirometry. Neither any patient developed bromage scale, and ropivacaine fentanyl group
complications related to epidural analgesia, nor had less motor blockade than bupivacaine –
any patient developed pulmonary infections, any fentanyl group. None of the patient had vomiting
cardiac morbidity, ileus or acute renal failure in only a few patients had mild nausea in the
perioperative period. postoperative period and it was not statistically
different. None of our patient had pruritus.
Epidural administration of local anesthetic-
opioid combination provides superior A review article by Gerg C. Meister, et al. [12] to
postoperative analgesia (including dynamic pain compare the effect of epidural analgesia with
relief), limits regression sensory blockade, and 0.125% ropivacaine with fentanyl to 0.125%
possibly decreases the dose of local anesthetic bupivacaine with fentanyl during labour
administered [9]. demonstrated no differences in verbal pain
scores, local anesthetic use, patient satisfaction,
C. N. H. Tan, et al. [10] found in their study the or side effects between groups and the
optimal concentration of fentanyl in bupivacaine ropivacaine/ fentanyl group developed
0.1% after thoracotomy is 5 µg/mL. They significantly less motor block than
compare the concentration of fentanyl 2 µg/mL, bupivacaine/fentanyl.
5 µg/mL and 10 µg/mL. They found 16 patients
in-group 10 were having sedation score >1 as Ayad, et al. [13] found in their study to compare
compare to 10 each in group 2 and group 5. epidural ropivacaine/ fentanyl versus
Number of patients with episodes of bupivacaine/fentanyl for postoperative analgesia
unsatisfactory pain VAS score > 30 mm and following lumbar disc surgery that patients in
Observer verbal rating scale (OVRS) > 1 at each group I ropivacaine 0.125% and fentanyl 2
of four hour assessment was significantly higher mcg/mL were having least incidence of motor
(p value< 0.01 ) in group 2 than in group 5 and blockade than group II bupivacaine 0.125% and
group 10. We also used the concentration of fentanyl 2 mcg/mL and group III bupivacaine
fentanyl 5 µg/mL and it was associated with 0.0625% and fentanyl 4 mcg/mL respectively
sedation score 1 in Four to ten patients (6.67%- 3%, 22 % and 6 %. This study also showed that
16.67%) which is desirable in the postoperative the decreasing concentration of local anesthetic
period. reduces the chances of motor blockade and
patients in group I developed less hypotension
Peter S. Hodgson, et al. [11] was found same (14.3%) as compare to group II (19.4%) and
findings in study to compare the ropivacaine with group III (18.8%) with p value of <0.05 for
fentanyl to bupivacaine with fentanyl for patient group II or III versus group I.
controlled epidural analgesia in abdominal
surgery. They found PCEA with In our study heart rate was not significantly
bupivacaine/fentanyl 4 µg/mL and ropivacaine/ different in all the four groups. Systolic Blood
fentanyl 4 µg/mL as 0.05% and 0.1% solutions pressure, diastolic blood pressure and mean
appears clinically equipotent. Lower-extremity blood pressure was significantly lower in group
motor function decreases during PCEA (10- B1 at all time intervals as compare to all other
35%decrease from preoperative, P<0.001) and three groups. Ropivacaine group patients
was equivalent among groups. Lower extremity developed less hypotension as compare to
motor function decreases, but is unlikely to result Bupivacaine group patients ‘p’ value (< 0.05) at
in prolonged inability to ambulate. Use of a all time intervals except for immediately shifting
0.05% solution may be advantageous to decrease the patients for SBP. For DBP it was significant
local anesthetic use and prevent transient motor at all time intervals (‘p’ value <0.05) except for
block. at fourty two hours. For MBP at all time intervals

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controlled epidural analgesia in patients undergone lower abdominal cancer surgery. IAIM, 2016; 3(7): 137-149.

it was statistically significant (‘p’ value <0.05). 4. Carli F, Mayo N, Klubein K, et al.
Respiratory rate and pulse oximetry were not Epidural analgesia enhances functional
significantly different among the groups. exercise capacity and health-related
quality of life after colonic surgery:
Patient satisfaction is an important consideration Results of a randomized trial.
in the field of postoperative pain management. Anesthesiology, 2002; 97: 540.
Postoperative pain management by 5. Thomas Standl, Marc Alexander
anesthesiology team in our hospital was Burmeister, Henning Ohnesorge,
satisfactory, which is evident by the fact that in Stephan Wihelm, Martina Striepke,
our study overall satisfaction concerning the pain Andre’Gottschalk, et al. Can J Anaesth.,
management regimen was good to excellent in all 2003; 50 (3): 258-264.
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monitoring, patient involvement in self-care and Efficacy of postoperative patient-
their control over pain. There is no statistically controlled and continuous infusion
significant difference between satisfaction level epidural analgesia versus intravenous
in all four groups (p=0.659). patient-controlled analgesia with opioids:
A meta-analysis. Anesthesiology, 2005;
Conclusion 103: 1079.
Our study demonstrated that, when infused 7. Liu SS, Block BM, Wu CL. Effects of
through a epidural catheter a solution of perioperative central neuraxial analgesia
ropivacaine 0.1% with fentanyl 5 µg/mL provide on outcome after coronary artery bypass
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Comparison of patient-controlled
Acknowledgement epidural analgesia with and without
The authors thank Dr. Rajiv Yadav and Dr. night-time infusion following
Garima Shekhar Sharma for their help. gastrectomy. Br J Anaesth., 2001; 87:
633.
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controlled epidural analgesia in patients undergone lower abdominal cancer surgery. IAIM, 2016; 3(7): 137-149.

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