|Year : 2016 | Volume
| Issue : 1 | Page : 50-54
A comparative study of spinal anesthesia with hyperbaric ropivacaine plus fentanyl and hyperbaric bupivacaine plus fentanyl in lower abdominal surgery and lower limb surgery
Kuber Khundongbam, Pradipkumar Laithangbam, Takhelkmayum Hemjit, Jack Asem, Eshori Longjam
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur, India
|Date of Web Publication||5-Feb-2016|
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur
Source of Support: None, Conflict of Interest: None
Background: Ropivacaine 15 mg is found to be equivalent to 10 mg bupivacaine for knee surgery in terms of hemodynamic stability and degree of motor blockade under spinal anaesthesia. The efficacy of hyperbaric preparations of the similar doses, when mixed with an opioid was evaluated in this study. Methods: Sixty adult patients, of both sexes with American Society of Anaesthesiologists status I/II undergoing lower abdominal and lower limb surgery were enrolled in this prospective, randomized, double blind study. Patients were randomly assigned into two groups: group B (bupivacaine group) and group R (Ropivacaine group). Patients in group B (n = 30) received hyperbaric 0.5% bupivacaine (2 ml) with fentanyl 0.4 ml and normal saline (0.25 ml). Group R patients received ropivacaine 0.75% (2 ml) with fentany l 0.4 ml, 0.2 ml of 50% dextrose and normal saline (0.05 ml). The spinal block characteristics, hemodynamic parameters, and onset time to pass urine were recorded and statistically analyzed. Results: There were no differences between the two groups in the mean time to attain highest sensory block level (group R 9.10 ± 1.97 min; group B 9.17 ± 1.51min; P > 0.05) and median maximum extent (ropivacaine T6; bupivacaine T5; P > 0.05); but the mean duration of sensory block regression to S2 was significant (ropivacaine 157.44 ± 17.78 min; bupivacaine 180.60 ± 23.06 min; P < 0.001). The degree of motor block by 5 min was significantly different between the groups (ropivacaine 1.50 ± 0.82; bupivacaine 2.40 ± 0.49; P < 0.001). Patients receiving ropivacaine mobilized sooner (ropivacaine115.47 ± 17.07 min; bupivacaine 154.60 ± 20.37 min; P < 0.001) and passed urine sooner (ropivacaine 236.38 ± 90.44 min; bupivacaine 289.85 ± 73.21 min; P = 0.037). Three patients in group B required treatment for hypotension. Conclusion: Hyperbaric ropivacaine 15 mg with fentany l 20 μg was found to be a better alternative to bupivacaine (heavy) 10 mg with better block characteristics and hemodynamic stability.
Keywords: Bupivacaine, fentanyl, local anesthetics, ropivacaine, spinal anesthesia
|How to cite this article:|
Khundongbam K, Laithangbam P, Hemjit T, Asem J, Longjam E. A comparative study of spinal anesthesia with hyperbaric ropivacaine plus fentanyl and hyperbaric bupivacaine plus fentanyl in lower abdominal surgery and lower limb surgery. J Med Soc 2016;30:50-4
|How to cite this URL:|
Khundongbam K, Laithangbam P, Hemjit T, Asem J, Longjam E. A comparative study of spinal anesthesia with hyperbaric ropivacaine plus fentanyl and hyperbaric bupivacaine plus fentanyl in lower abdominal surgery and lower limb surgery. J Med Soc [serial online] 2016 [cited 2020 May 24];30:50-4. Available from: http://www.jmedsoc.org/text.asp?2016/30/1/50/175852
| Introduction|| |
Ropivacaine, a new long-acting amide local anesthetic, was introduced in clinical practice with the claim that it causes less motor block than bupivacaine, , and as an alternative to hyperbaric lignocaine because of its higher incidence of transient neurologic symptoms and cauda equina syndrome.  The effect of ropivacaine has also been claimed to be less cardiotoxic than that of bupivacaine. 
While some study compared the high dose of plain bupivacaine (17.5 mg) with a similar dose of plain ropivacaine for major orthopedic surgery,  this high dose may not be suitable for all patients. It has been observed that 15 mg of ropivacaine is equivalent to 10 mg of bupivacaine with regard to hemodynamic changes and motor blockade but is less potent as an anesthetic agent. 
The addition of fentanyl has been found to increase sensory block without increasing motor block or time to micturition. , Also, it is found that ropivacaine plain is less reliable for surgery above L1 dermatome. The addition of glucose 50 mg/mL makes the solution hyperbaric, with faster onset of block, greater reliability, and prolongation of the duration of action.  Thus, we performed this randomized, double-blinded study to compare the anesthetic characteristics and hemodynamic effects between freshly prepared hyperbaric ropivacaine 0.75% with hyperbaric bupivacaine 0.5%, along with fentanyl 20 μg for lower abdominal surgery and lower limb surgery.
| Materials and Methods|| |
This prospective, randomized, double-blinded study was conducted on 60 adult patients of both genders of the American Society of Anesthesiologists (ASA) physical statuses l to II, aged between 18 years and 65years, scheduled for lower abdominal surgery and lower limb surgery under spinal anesthesia after the institutional ethics committee's approval and written informed consent at a tertiary care hospital. Patients with known allergy to any study drugs, contraindications to neuraxial block, and those patients in whom informed consent could not be obtained were excluded from the study.
Based on previous study,  the mean duration of action of ropivacaine and bupivacaine were assumed to be 120 min and 180 min, respectively, with sigma value (common standard deviation) of 80 min; the sample size calculated for our study was 30 in each group for α = 0.5 and power (1-β) value of 80%.
Patients were randomly divided into two groups of 30 each, which was computer-generated. Group R patients received ropivacaine (0.75%) 2 mL with 0.2 mL of 50% dextrose and fentanyl 20 μg (0.4 ml), the final volume being adjusted to 2.65 mL with normal saline solution. The specific gravity of the solution was 1.148. Group B patients received a similar volume of 2.65 mL by mixing the available hyperbaric bupivacaine (0.5%) 2 mL or 10 mg with fentanyl 20 μg (0.4 ml), and 0.25 mL of normal saline solution. The specific gravity of the solution was 1.160. The specific gravity of both the solutions were checked at the Biochemistry Department of the hospital. The hyperbaric ropivacaine solution was prepared aseptically, immediately before injection based on an earlier study conducted by Whiteside et al. 
On the night before operation, all the patients received tablet ranitidine 150 mg and tablet alprazolam 0.5 mg. On arrival at the preanesthetic room, a suitable peripheral intravenous (IV) assess was performed with an 18-gauge cannula. Injection metoclopramide 10 mg IV and injection ranitidine 50 mg IV were given 1.5 h before operation. Preloading was given with 8-10 mL/kg of ringer lactate over 10-15 min. All the patients were asked to void before shifting to the operation theater. In the operation theater, standard monitoring with electrocardiogram (ECG), noninvasive arterial blood pressure (NIBP), and pulse oximetry (SPO2) were started, and baseline readings were assessed. Then, in the right lateral position and under aseptic and antiseptic precautions, lumbar puncture was performed using a midline approach at the second and third lumbar intrathecal spaces (L2-3) using a 25G Quinke spinal needle (B Braun Melsungen AG, Germany) with bevel-end facing cephalad. The prepared anesthetic drugs were injected over 10 s. The study drugs with calculated volume and doses were prepared and given by an anesthetist not involved in the study.
Just after intrathecal injection of drugs (taken as 0 min), all the patients were kept in a supine horizontal position, and readings of blood pressure (BP), heart rate (HR), and mean arterial pressure (MAP) were taken. The degree of motor block onset in the lower limbs was assessed at 5 min, 10 min, and 15 min using a modified Bromage scale (MBS).  Highest sensory block level attained was checked by using the pinprick method. Intraoperative hemodynamic parameters (BP, HR, and MAP) were assessed at 1 min, 2 min, 3 min, 5 min, 10 min, 15 min, 30 min, 45 min, and 60 min.
Upon arrival at the postoperative care unit (PACU), postoperative hemodynamic parameters (BP, HR, and MAP) were recorded at 0 min: Time taken when patients just arrived at the postoperative recovery unit, and then at 10 min, 20 min, 30 min, and 40 min. Motor block regression in the lower limbs was assessed by using MBS at 0-60 min, 60-120 min, and 120-180 min intervals.
Sensory blockade regression time up to S2 was checked by using the pinprick method in the mid clavicular line bilaterally. Then, assessments were continued until complete regression of motor block in the lower limbs, and sensory block to S2.
Hypotension, defined as a fall in systolic blood pressure >20% from the baseline was treated with IV injection of mephentermine 3 mg or IV fluids or both based on requirements. A fall in heart rate <50 beats/min was considered as bradycardia and treated with injection atropine 0.3 mg IV.
Time to the first onset of micturition (in minutes) was recorded; bladder catheterization was performed only if surgically indicated.
Modified Bromage Scale 
0 Full movement.
1 Inability to raise extended leg but can bend knee.
2 Inability to bend knee but can flex ankle.
3 No movement.
All satisfaction scores of the patients were assessed by using the following scoring systems:
Patient Comfort Score (PCS) 
- Complete absence of sensation in the operative limb.
- Sensation of limb motion only but with no discomfort present.
- Mild discomfort but with the patient declining any offer of further analgesia or with no obvious clinical need for such further intervention.
- Patient expresses wish for additional analgesia or exhibits an obvious clinical need for such intervention.
Global Patient Satisfaction Scale (verbal) 
- Very dissatisfied.
- Slightly dissatisfied.
- Neither satisfied nor dissatisfied.
- Highly satisfied.
Injection midazolam 1.5 mg with injection pentazocine 15 mg were given intravenously in case of patients with complaints of uncomfortable legs and anxiousness. All the operations were performed successfully in both the groups.
Results are expressed as mean values ± standard deviation (SD) or median value if appropriate. categorical data were compared using chi-square analysis, and for continuous data, t-test analysis was used. All data were analyzed by using Statistical Package of Social Sciences (SPSS Software Version 21). Results were considered significant if P < 0.05.
| Results|| |
In the pilot study, the mean specific gravity of the freshly prepared hyperbaric ropivacaine 0.75% solution (by the addition of 50 mg/mL dextrose) observed was 1.148 and hyperbaric bupivacaine 0.5% was 1.160. The two groups were comparable with regard to age, sex, height, weight, ASA status, and types of surgeries [Table 1].
Median maximum sensory block height level with pinprick analgesia was T5 in group B and T6 in group R [[Table 2]; P > 0.05]. The time taken to attain highest sensory block level in group B was 9.17 ± 1.51 min while 9.10 ± 1.97 min in group R (P = 0.88) and the total duration of sensory block regression to S2 was faster with ropivacaine (bupivacaine 180.60 ± 23.06 min; ropivacaine 157.44 ± 17.78 min; P < 0.001).
The degree of motor block onset (MBS) within 15 min was shorter in ropivacaine group by 5 min (bupivacaine 2.40 ± 0.49; ropivacaine 1.50 ± 0.82; P < 0.001). The mean time to complete regression of motor block was 154.6 min in group B compared with 115.5 min with group R (P < 0.001).
The cardiovascular changes between the two groups during intraoperative and postoperative (40 min of PACU time) were comparable [Figure 1] and [Figure 2]. Three patients in the bupivacaine group required injection mephentermine 3 mg IV intraoperatively to correct hypotension while none required it in the ropivacaine group. Patients in group R were able to mobilize their lower limbs faster (ropivacaine 115.47 ± 17.07 min; bupivacaine 154.60 ± 20.37 min; P < 0.001) and passed urine sooner than those in the bupivacaine group (236.38 ± 90.44 min in group R while 289.85 ± 73.21 min in case of group B; P = 0.037).
|Figure 1: Comparison of intraoperative mean arterial blood pressure and heart rate|
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|Figure 2: Comparison of postoperative mean arterial pressure and heart rate|
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In the ropivacaine group, there were less number of patients having legs discomfort and requiring sedations and additional analgesics compared to bupivacaine (P = 0.002) [Table 3].
The intraoperative mean arterial blood pressure and heart rate distribution in the two groups fell gradually over 10-15 min, and thereafter increased slowly before reaching less than the baseline value. However, the fall was more in group B but was not statistically significant [P > 0.05; [Figure 1]].
| Discussion|| |
In the present study, the two groups were comparable as regards the demographic profile (age, sex, weight, height, ASA, and surgical procedure; [Table 1]; P > 0.05), Kallio et al.  while comparing hyperbaric and plain ropivacaine reported that intrathecal hyperbaric ropivacaine 15 mg resulted in a faster onset, greater success rate of analgesia at the level of T10 dermatome, and faster recovery of blocks. Another study conducted by Ben David et al.  found that the addition of fentanyl increases the level and duration of sensory block without altering the motor block characteristics. It resulted in the use of smaller doses of local anesthetic, minimizing the duration of motor block, lower incidence of excessively high block, and hypotension.
Successful blocks with ropivacaine 12 mg have been described in arthroscopy  and unilateral spinal anesthesia.  On the other hand, for operations in which higher block is required even much higher doses have proved insufficient. Wahedi et al.  had a failure rate of 20% with intrathecal plain ropivacaine 15 mg (3 mL of 5 mg /mL) in abdominal surgery and Malinovsky et al.  found 16% failure of spinal anesthesia with plain ropivacaine 15 mg (5 mL of 3 mg/mL) for urological surgery. In case of unilateral spinal anesthesisa, bilateral sensory block occurred in 85% of the patients in the bupivacaine group versus 40% in the ropivacaine group. The incidence of bilateral block in a study by Bigat et al. was 70% in the bupivacaine group and 25% in the ropivacaine group. 
In our study for lower abdominal surgery and lower limb surgery, patients required at least midthoracic block, and we used 15 mg of freshly prepared hyperbaric ropivacaine, which provided reliable anesthesia of shorter duration and minimal hypotension. In two patients in the ropivacaine group, the surgeons were complaining of mild abdominal muscle tightness but proceeded with the surgery after IV injection of midazolam 1.5 mg.
The degree of motor block onset in the lower limb was found to be slower in group R (MBS of 1.50 ± 0.82) compared to group B (MBS 2.40 ± 0.49; P < 0.001) by 5 min. This is in contrast to some of the early studies, which found that there was no difference in the onset time of motor block. ,
Regarding motor block regression from grade 3 to grade 0, it was significantly shorter in the ropivacaine group. Patients in the ropivacaine group could move their lower limbs comparatively faster than the bupivacaine group (Group R 115.47 ± 17.07 min; Group B 154.60 ± 20.37 min; P < 0.001), which is in agreement with the conclusions of earlier studies. ,,
The time to first onset of micturition was 236.38 ± 90.44 min in the ropivacaine group and 289.85 ± 73.21 min in the bupivacaine group (P = 0.037). A similar finding was reported by Kulkarni et al.  and Whiteside et al.  The hemodynamic parameters were found to be comparable between the groups [Figure 1] and [Figure 2].
In the present study, three patients (10%) in the bupivacaine group required injection mephentermine 3 mg IV to correct hypotension while in a study conducted by McNamec et al.,  injection ephedrine 3 mg was used to correct hypotension in 26% of the patients in thebupivacaine group and 12% patients in the ropivacaine group.
No episode of bradycardia was observed in both the groups. Satisfaction scores of the patients assessed with PCS  were found to be statistically significant (P = 0.002) [Table 3] in both the groups.
The present study shows that glucose-containing solutions of hyperbaric ropivacaine can produce predictable and reliable spinal anesthesia for a wide range of surgical procedures. This is in contrast to the result of some earlier study of intrathecal ropivacaine, which described a variation in the spread of the local anesthetic agents and found it to be frequently inadequate for surgery. 
Due to the nonavailability of standard densitometer in the operation theater, the baricity of every freshly prepared hyperbaric ropivacaine solution was not checked and hence, baricity was only tested during a pilot study. Also, hyperbaric ropivacaine is not available commercially; extreme antiseptic care is required to prepare the hyperbaric solutions. Apart from this, 50% dextrose is not freely available in this part of India.
| Conclusion|| |
It maybe concluded that freshly prepared hyperbaric ropivacaine 15 mg (of 0.75% in 5.0% dextrose) is a better alternative to hyperbaric bupivacaine (0.5%) with fentanyl for undergoing lower abdominal surgery and lower limb surgery, with faster onset and recovery of motor and sensory blocks, shorter duration of time to onset of micturition, and better hemodynamic stability and PCS than the commercially available hyperbaric bupivacaine
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Conflicts of interest
The authors declare that there is no conflict of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]