|Year : 2015 | Volume
| Issue : 1 | Page : 89-92
Comparison of intrathecal hyperbaric bupivacaine and levobupivacaine for Cesarean section
Feroz A Dar, Ishrat H Mir, Hilal A Bhat
Department of Anaesthesia and ICU, SKIMS Medical College, Srinagar, Jammu and Kashmir, India
|Date of Submission||25-Aug-2014|
|Date of Acceptance||26-Dec-2014|
|Date of Web Publication||25-Mar-2015|
Feroz A Dar
Department of Anesthesiology and Critical Care, S.K.I.M.S Medical College and Hospital, Jammu and Kashmir
Source of Support: None, Conflict of Interest: None
Levobupivacaine is a relatively new amide local anesthetic, and it has been already investigated in epidural and locoregional techniques, but more has to be known regarding its characteristics in spinal anesthesia.
The aim of our study was to compare clinical and anesthetic features of levobupivacaine and racemic bupivacaine when intrathecally administered in patients undergoing elective Cesarean section.
Patients and methods
Hundred patients of ASA I and II were randomized to receive an intrathecal injection of one of two local anesthetic solutions. Each patient in group L (n = 50) received 2 ml of isobaric levobupivacaine 5 mg/ml (10 mg) with 15 μg of fentanyl, whereas each patient in group B (n = 50) received 2 ml of hyperbaric bupivacaine (10 mg) with 15 μg of fentanyl. The parameters studied were onset and total duration of sensory block, onset and total duration of motor block, the quality of intraoperative anesthesia, hemodynamic alterations, and any intraoperative and postoperative complications.
There were no significant differences in demographic or surgical variables between the two groups. There was no significant difference in the quality of anesthesia and intraoperative side effects in the two groups. Time to complete regression of motor blockade was statistically lower in group L (135 ± 15.6 vs. 145 ± 20.5 min; P < 0.005) compared with group B. There were no significant differences in onset of sensory and motor block in the two groups. The total duration of sensory at T 12 level in group L (168.3 ± 15.6 vs. 172.2 ± 20.5 min; P > 0.005) was nonsignificant when compared with group B.
Levobupivacaine, the pure S (-) enantiomer of racemic bupivacaine, is an equally effective local anesthetic for spinal anesthesia for Cesarean section, compared with racemic bupivacaine.
Keywords: bupivacaine, intrathecal, levobupivacaine
|How to cite this article:|
Dar FA, Mir IH, Bhat HA. Comparison of intrathecal hyperbaric bupivacaine and levobupivacaine for Cesarean section. Ain-Shams J Anaesthesiol 2015;8:89-92
|How to cite this URL:|
Dar FA, Mir IH, Bhat HA. Comparison of intrathecal hyperbaric bupivacaine and levobupivacaine for Cesarean section. Ain-Shams J Anaesthesiol [serial online] 2015 [cited 2023 Nov 28];8:89-92. Available from: http://www.asja.eg.net/text.asp?2015/8/1/89/153948
| Introduction|| |
Levobupivacaine is a local anesthetic that is relatively new to clinical practice. Levobupivacaine is an S (-) enantiomer of bupivacaine, and both agents have similar pharmacokinetic properties ,, . There are several studies that have reported that the cardiovascular and central nervous system-related side effects of levobupivacaine are less frequent than those experienced with bupivacaine , . On the basis of these reports, levobupivacaine is recommended as an alternative to bupivacaine for patients who experience cardiovascular system-related side effects. However, it has been emphasized that more studies must be conducted to investigate the effects of levobupivacaine in detail. Despite the fact that levobupivacaine has been widely used for obstetric and nonobstetric epidural anesthesia, there is still a lack of comparative clinical studies that focus on intrathecal levobupivacaine administration. This study aimed to compare these two intrathecal anesthetics, bupivacaine and levobupivacaine, for their effects on motor and sensory blockade and hemodynamic parameters in patients who underwent elective Cesarean under spinal anesthesia.
| Patients and methods|| |
This prospective double-blinded randomized study was performed between January and July 2014 at Sheri-Kashmir Institute of Medical Science, College and Hospital. The study was approved by institutional ethics committee, and patients provided written informed consent before inclusion. A total of 100 patients aged 22-40 years, classified as ASA I-II and undergoing elective Cesarean surgery, were included in the study. Patients with history of allergy to any study drug, with any contraindication to regional anesthesia, pregnancy-associated hypertension, and placenta previa were not included in the study.
All patients were evaluated initially by medical history and a complete physical examination. After intravenous prehydration with 500 ml of Ringer's lactate infusion, hemodynamic variables were monitored with ECG, systolic and diastolic blood pressure, heart rate, and oxygen saturation (SpO 2 ). After disinfecting the skin and infiltrating with 2% lidocaine, lumbar puncture was performed at the L3-L4 interspace using a 25 G Quincke point needle. Patients were randomized (computer-generated random numbers and envelope randomization) to either group B receiving 10 mg (2 ml) hyperbaric bupivacaine (Anawin; Neon Laboratories Limited, Boisar Road Palghar (Thane), M.S, India) and 15 mcg (0.5 ml) fentanyl or group L receiving 10 mg (2 ml) isobaric levobupivacaine (Levowin; Neon) and 15 mcg (0.5 ml) fentanyl, being a total of 2.5 ml, administered intrathecally within some 10 s. Oxygen 5 l/min was administered through a facial mask. The hemodynamic parameters were monitored at first, third, and fifth minute and then recorded every 5 min until the completion of surgery. The sensory-motor block was recorded at baseline before spinal injection, then at every 1 min for the first 10 min after injection, every 2 min for the next 10 min, and at every 15 min until reversal of sensory-motor block. Pin-prick test was used for sensorial block evaluation. Considering the time of intrathecal injection as time zero, the time to onset of sensory block, the time taken to reach maximum sensory block level, and the duration of the regression of the sensory block level to T 12 from the maximum level were recorded, and time to first analgesic need was recorded as first analgesia time. The most frequently used measure of motor block is the Bromage scale. In this scale, the intensity of motor block is assessed by the patient's ability to move their lower extremities (0 = Free movement of legs and feet; 1 = Just able to flex knees with free movement of feet; 2 = Unable to flex knees, but with free movement of feet; 3 = Unable to move legs or feet). 'Onset of motor block' is recorded as when Bromage scale is '1' after administration of local anesthetics; 'onset of highest motor block' is recorded as time to reach the highest scale of motor block; and 'motor block time' is recorded as time to complete termination of motor block. The quality of intraoperative anesthesia was assessed using 'Four Grade Scale', which is defined as: Excellent = No supplementary sedative or analgesia required; Good = Only sedative required; Fair = Both sedative and analgesic required; Poor = General anesthesia and tracheal intubation required.
Bradycardia (heart rate < 60 beats/min), when encountered, was recorded and treated with intravenous atropine, which was administered in small incremental doses. Mean arterial pressure decrease of 30% of mean arterial pressure before block was accepted as hypotension. It was treated with fluid replacement and incremental intravenous doses of ephedrine. The amount of ephedrine used for each patient was recorded. The patients were observed for first 24 h for pruritus, respiratory depression, nausea, vomiting, and any other complications.
Statistical data analysis
Statistical analysis was performed and analyzed with the GraphPad.com (version 5, 2010 GraphPad Software, Inc. 7825 Fay Avenue, Suite 230, La Jolla, CA 92037, USA). On simple interactive statistical analysis, sample size of minimum 28 was derived using the formula for sample size calculation for multiple comparison (two tailed) based on the assumption of α (type 1 error) of 5%, β (type 2 error) 0.2, and power of the study 80% to detect a difference of 35%. To increase the power of study, we included 50 patients in each group. The calculation of the required sample size was also based on the previous investigation , . Numerical variables were presented as mean and SD for patient characteristics such as age, weight, height, block parameters such as onset, duration, and recovery time of sensory block, time to maximum motor blockade, duration of motor blockade, and time to first analgesic. Categorical variables were presented as frequency and percent and analyzed using the χ2 -test for patients' characteristics such as ASA status, Bromage grade of motor blockade, and incidence of adverse events such as hypotension, bradycardia, vomiting, and shivering. Student's 'unpaired t-test' for comparisons of mean and proportion was used wherever appropriate. P value less than 0.05 was considered to be statistically significant.
| Results|| |
There has been no statistically significant difference between the groups in terms of their demographic characteristics and the duration of the operation ([Table 1]).
There were no significant differences between the two groups in the quality of sensory and motor block as shown in [Table 2]. The peak block height in group L was T 4 and in group B was T 6 . No statistically significant difference was seen in the onset of sensory and motor blockade. Time to complete regression of motor blockade was statistically lower in group L (135 ± 15.6 vs. 145 ± 20.5 min; P < 0.005) compared with group B ([Table 3]). Complete motor blockade was eventually achieved in 48 of 50 patients in group L (96%) and 49 of 50 patients in group B (98%). Only the highest level of sensory block difference was statistically significant but clinically nonsignificant. No patient had anesthesia rated as failure or unsatisfactory by the surgeon or anesthetist. The intraoperative quality of anesthesia was excellent and similar in both groups. However, it was fair in 1% in the bupivacaine group and it was statistically nonsignificant between the two groups (P > 0.05). No patient had anesthesia rated as failure or unsatisfactory by the surgeon or anesthetist. There was no significant difference in recovery of sensory blockade time to T 12 level. However, there was a significant difference in recovery of motor blockade between the two groups (P < 0.005).[Table 4]
With respect to intraoperative adverse events, hypotension was reported in 12 of 50 cases (24%) in group L compared with 15 of 50 cases (30%) in group B (P = 0.652). The doses of ephedrine were 12.5 ± 2.5 and 12.1 ± 1.5 mg, respectively. Shivering incidence was statistically significant in group L; other adverse events showed no significant differences between the groups as shown in [Table 3].
It was observed that the requirement of intraoperative ephedrine for each patient was same between the two groups, and the time to first analgesic requirement was significantly longer in group B (210 ± 12.5 vs. 190.5 ± 15.0 P < 0.05) compared with group L.
| Discussion|| |
Levobupivacaine is a relatively new amide local anesthetic and has been recently introduced into clinical practice because of its lower toxic effects on the heart and central nervous system. It has been already investigated in epidural and locoregional techniques, but more has to be known regarding its characteristics in spinal anesthesia. The aim of our study was to compare clinical and anesthetic features of levobupivacaine and racemic bupivacaine when intrathecally administered in patients undergoing elective Cesarean section.
We observed in our study that 0.5% isobaric levobupivacaine, the pure S (-) enantiomer of racemic bupivacaine, is as effective as 0.5% hyperbaric bupivacaine for spinal anesthesia in Cesarean section. Onset time of sensory and motor blocks, peak block height, and recovery time of the sensory and hemodynamic alterations are similar to those obtained with racemic bupivacaine. In most of the studies, where levobupivacaine and bupivacaine were investigated, sensory and motor block characteristics were found to be similar. Sathitkarnmanee et al.  and Fattorini et al.  compared 3 ml 0.5% isobaric bupivacaine with levobupivacaine, and both reported that there was no significant difference in terms of maximum distribution and durations of sensory and motor block. In another comparative study conducted by Mehta et al.  , they reported that the levobupivacaine can be used with equal efficacy and better safety as bupivacaine at similar doses in subarachnoid block. In a dose-effect study comparing racemic bupivacaine and levobupivacaine in patients undergoing urological surgery, Lee et al.  reported that 2.6 ml 0.5% racemic bupivacaine and levobupivacaine have a nearly equivalent clinic profile and hemodynamic effects. In another study conducted in volunteers, spinal anesthesia was administered at doses of 4, 8, and 12 mg using hyperbaric spinal levobupivacaine and racemic bupivacaine; sensory and motor block characteristics at different doses were compared. It has been reported that, at the same doses, hyperbaric levobupivacaine and racemic bupivacaine have the same effects  .
Hypotension is the most common complication in spinal anesthesia  . Administering hydration using crystalloid or colloid before spinal anesthesia has proved insufficient  . Thoren et al.  reported that the rate of occurrence of hypotension was 62% in elective Cesarean operations in which they administrated spinal anesthesia with 2.5 ml 0.5% bupivacaine. In our study, the incidence of hypotension with bupivacaine was found to be 30% and 24% with levobupivacaine. We believe that this difference in our results might be related to the fact that we had decreased the dose of local anesthetic and added fentanyl. Herrera et al.  conducted observational pilot study to assess the hemodynamic impact of subarachnoid anesthesia with isobaric levobupivacaine versus hyperbaric bupivacaine for hip fracture surgery and observed better hemodynamic stability and lower incidence of intraoperative hypotension in the levobupivacaine group. Guler et al.  in a randomized trial also reported that the side effects such as hypotension, bradycardia, and nausea are less in intrathecal levobupivacaine compared with intrathecal bupivacaine. In regional anesthesia for Cesarean sections, nausea and vomiting can occur because of few factors. The most important reason is that cerebral blood flow decreases in consequence of hypotension. Other reasons are related to the level where block reaches. It may as well occur because of an increase in the block level or because of the fact that structures related to peritonea stretch during the operation due to an inadequate block level. We can explain the reduced incidence of nausea in the levobupivacaine group with the fact that the doses we administered developed adequate blocks and caused less hypotension.
| Conclusion|| |
Levobupivacaine, the pure S (-) enantiomer of racemic bupivacaine, is an equally effective local anesthetic for spinal anesthesia for Cesarean section, compared with racemic bupivacaine with respect to onset and duration of sensory blockade. On the basis of these data, levobupivacaine is an interesting alternative to bupivacaine for spinal anesthesia.
| Acknowledgements|| |
Conflicts of interest
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[Table 1], [Table 2], [Table 3], [Table 4]