|Year : 2015 | Volume
| Issue : 2 | Page : 78-83
A comparison of intrathecal levobupivacaine with hyperbaric bupivacaine for elective cesarean section: A prospective randomized double-blind study
Rashmi Duggal1, Ruchi Kapoor2, Gajendra Moyal3
1 Department of Anesthesia, Mrs. Girdhari Lal Maternity Hospital, North Delhi Municipal Corporation, New Delhi, India
2 Department of Anesthesia and Critical Care, Hindu Rao Hospital, New Delhi, India
3 Department of Anesthesia, Mrs. Girdhari Lal Maternity Hospital, New Delhi, India
|Date of Web Publication||11-Sep-2015|
Dr. Rashmi Duggal
E 238, Ground Floor, Greater Kailash, Part - I, New Delhi - 110 048
Source of Support: None, Conflict of Interest: None
Background: There is a constant endeavor for newer, safer anesthetic agents providing effective block characteristics and having minimal side effects. Hyperbaric bupivacaine is the most frequently used anesthetic agent for cesarean section. Levobupivacaine is less toxic to the heart and central nervous system, but there are few studies of its use in cesarean section, hence the present study was undertaken to compare the quality of sensory and motor block and side effects if any, following intrathecal levobupivacaine and hyperbaric bupivacaine, in parturients undergoing elective cesarean section.
Materials and Methods: Sixty American Society of Anesthesiologists I or II parturients for the elective cesarean section were enrolled in this prospective randomized, double-blind study. Using computer generated codes, the parturients were randomly assigned to two groups with patients in Group L (n = 30) and Group B (n = 30). Subarachnoid block was performed with 2 ml of 0.5% isobaric levobupivacaine in Group L and 2 ml of 0.5% hyperbaric bupivacaine in Group B. Characteristics of sensory and motor block were assessed with pinprick and Bromage scale, respectively. Side effects such as hypotension, bradycardia, nausea, and vomiting were recorded.
Results: Both the duration of sensory and motor block were shorter in parturients in Group L than those in Group B (80.03 ± 8.12 vs. 103.47 ± 10.18 min and 64.37 ± 7.42 vs. 94.70 ± 9.18 min), the difference being highly significant (P < 0.001). None of the patients required analgesic supplementation intraoperatively. The maximum sensory block height achieved in Group L was significantly lower than Group B (P = 0.003). The incidence of side effects (hypotension, bradycardia, nausea, and vomiting) was lower in Group L as compared to Group B (10% vs. 33.3%, 3% vs. 16%, 6.6% vs. 26% and 0% vs. 3.3%); with P < 0.05 for hypotension and nausea.
Conclusion: Adequate surgical anesthesia can be achieved with both levobupivacaine and hyperbaric bupivacaine as tested by the loss of pinprick sensation in both groups. Levobupivacaine given intrathecally can provide safe and effective analgesic choice for parturients undergoing elective cesarean section as the incidence of side effects with its use was significantly lower in comparison to hyperbaric bupivacaine.
Keywords: Cesarean section, hyperbaric bupivacaine, intrathecal, levobupivacaine
|How to cite this article:|
Duggal R, Kapoor R, Moyal G. A comparison of intrathecal levobupivacaine with hyperbaric bupivacaine for elective cesarean section: A prospective randomized double-blind study. J Obstet Anaesth Crit Care 2015;5:78-83
|How to cite this URL:|
Duggal R, Kapoor R, Moyal G. A comparison of intrathecal levobupivacaine with hyperbaric bupivacaine for elective cesarean section: A prospective randomized double-blind study. J Obstet Anaesth Crit Care [serial online] 2015 [cited 2020 Nov 24];5:78-83. Available from: https://www.joacc.com/text.asp?2015/5/2/78/165135
| Introduction|| |
The subarachnoid block is a safe and time-tested technique for administering anesthesia for cesarean section due to its rapid onset and effective sensory and motor blockade. Bupivacaine is available as a racemic mixture of its enantiomers, dextrobupivacaine and levobupivacaine  and is the most frequently used anesthetic agent for cesarean section. It is available as a plain or hyperbaric solution. Plain bupivacaine is hypobaric when compared with cerebrospinal fluid (CSF) ,,, and its use may result in variable block height with a possible block failure or high block. The addition of 8% glucose makes the solution hyperbaric and the resultant block more predictable and safe. Although hyperbaric bupivacaine in the most commonly used drug for spinal anesthesia, it too, has been known to cause sudden cardiac arrest after spinal anesthesia due to extension of the sympathetic block , and may cause hypotension or bradycardia after mobilization, especially with abrupt position changes. The use of truly isobaric solutions may prove less sensitive to position issues.  Levobupivacaine is one such anesthetic which is a pure enantiomer of racemic bupivacaine, is truly isobaric with respect to CSF of pregnant women  and is less toxic to the heart and CNS.  Its baricity offers an advantage of providing a less position sensitive block.  The claimed benefits of this agent are reduced cardiac toxicity on overdose ,, and more specific effects on sensory rather than motor nerve fibers. The decreased toxicity of levobupivacaine is attributed to its faster protein binding rate. There are very few studies using levobupivacaine in elective cesarean section so a randomized, double-blind study was conducted to compare the block characteristics and side effects, of intrathecal levobupivacaine with hyperbaric bupivacaine, in parturients posted for elective cesarean section.
| Materials and Methods|| |
Sixty women scheduled for elective cesarean delivery, at more than 37 weeks gestation, American Society of Anesthesiologists physical status Class I or II, were enrolled into this prospective randomized, double-blind study conducted after institutional ethical approval and informed consent taken.
Parturients refusing regional anesthesia, those having spinal deformity or known hypersensitivity to local anesthetics, having placental or fetal abnormalities, those with a body weight over 100 kg, extremes of height (<150 cm or more than 180 cm), those having gestational or pregnancy-induced hypertension and those receiving medications besides iron/vitamin supplements were excluded from the study.
Computer generated codes were used for randomization, and these were not revealed unless patients interactions were allotted. The parturients were made familiar to the methodology for sensory and motor block assessment during the preanesthetic checkup. All parturients received 150 mg ranitidine orally the night before and on the morning of surgery along with 10 mg of intravenous metoclopromide 1-h prior to surgery. On arrival in the operation theater, all routine monitors were applied (noninvasive blood pressure, pulse oximetry, electrocardiography, and temperature) and oxygen 4l/min given by face mask. An infusion was started after insertion of an intravenous cannula on the nondominant hand. Coloading was done with 10 ml/kg of lactated Ringer's solution. Baseline recordings of heart rate, systolic, diastolic and mean blood pressure were taken, and the patient placed in the sitting position. Under all aseptic precautions and after infiltration of local anesthetic a 25/26-gauge quincke point needle was introduced in the L3-L4 interspace and the duramater punctured for the administration of the local anesthetic solution. Patients were randomly divided into two groups: Group L and Group B. Paturients in Group L received 2 ml of 0.5% isobaric levobupivacaine (10 mg) and those in Group B received 2 ml of 0.5% hyperbaric bupivacaine (10 mg) intrathecally. The anesthesiologist administering the study drugs as well as the patients were blinded to the group allocation. The patients were placed supine with a left lateral tilt following the subarachnoid block. Surgery was allowed to start once T 6 or above level of sensory block was achieved.
Heart rate, blood pressure, sensory and motor block were recorded every 1-min for the first 15 min, and then every 5 min till the end of surgery. Sensory and motor block was assessed till the time to first analgesic requirement and complete recovery. Sensory level of block was assessed bilaterally in the anterior axillary line by loss of pinprick sensations, using a short beveled 25-gauge needle. Time zero corresponded to the time of intrathecal injection. The loss of discrimination to pinprick at T 10 dermatome was taken as the onset of sensory block. Thereafter, the duration of sensory block was assessed using two segment regression and time to first analgesic requirement. The duration of analgesia was the time between intrathecal injection and first additional analgesic requirement.
The modified Bromage scale was used for assessment of motor block (0 = No paralysis, able to flex hips/knees/ankles; 1 = Able to move knees, unable to raise extended legs; 2 = Able to flex ankles, unable to flex knees; 3 = Unable to move any part of the lower limb). The time to onset of motor block, the time to reach a maximum level and duration (as the time between time to reach a maximum level and complete disappearance) were recorded.
Side effects such as hypotension, bradycardia, nausea, and vomiting were recorded. Hypotension was defined as a >20% decrease in mean arterial pressure from its baseline value. It was treated with 3-6 mg boluses of mephentermine till return to within 20% of baseline pressure. The total dose used was recorded. Bradycardia was defined as a pulse rate of <50 beats/min and was treated with 0.6 mg intravenous atropine. Time to first analgesic requirement in the postoperative period was recorded and the planned treatment included incremental 25 mg boluses of intravenous tramadol. Intraoperative and postoperative nausea and vomiting were recorded. Patient having persistent nausea or vomiting were treated with 4 mg intravenous ondansetron. Apgar scores both at birth and at 5 min were noted in both groups.
The sample size was calculated to be 30 for each group based on the duration of analgesia (mean and standard deviation) in both groups from previous studies. This was obtained after accepting an alfa error of 5% (95% confidence interval) and beta error of 20%. SPSS statistical software package (version 17 Illinois, Chicago, USA) was employed for statistical analysis. To see whether data distribution was normal Shapiro-Wilk normality test was used. lndependent sample T-Test was employed for comparing variables with normal distribution.
Mann-Whitney U-test was used for variables which did not show normal distribution.
Pearson's Chi-square test was used to compare qualitative variables. P < 0.05 was considered to be statistically significant and P < 0.001 as highly significant. Data were presented as mean or median where appropriate.
| Results|| |
A total of 63 patients for elective cesarean sections under spinal anesthesia were taken up for the study. Finally 60 patients were analyzed [Figure 1].
The two groups were comparable with respect to patient characteristics [Table 1]. The adequate sensory block was achieved in both groups as none of the patients required additional analgesia intraoperatively.
Block characteristics are illustrated in [Table 2]. For sensory block both the onset and time to reach a maximum level were comparable in both the groups (P > 0.05). Maximum block height achieved in Group L was significantly lower than Group B (P = 0.003) with a variable dermatomal spread in both groups [Table 3]. The time to regression by two dermatomes and duration of sensory block (time to first analgesic requirement) were shorter in Group L as compared to Group B, the difference being highly significant (P < 0.001).
For the motor block, the onset was faster and the duration longer in Group B, the difference being highly significant (P < 0.001). The complete motor block was obtained within 12 min in every patient in both groups (Bromage 3).
The incidence of hypotension and nausea were significantly less in the Group L as compared to Group B (P < 0.05). The incidence of bradycardia and vomiting were less in Group L in comparison to Group B; although the difference was not significant statistically (P > 0.05) [Table 4].
| Discussion|| |
The results of the present study indicate that in parturients undergoing elective cesarean section isobaric levobupivacaine provides equally effective analgesia, lesser duration of the motor block and offers the distinct advantage of hemodynamic stability when compared to hyperbaric bupivacaine.
The results in the present study are similar to those reported in prospective randomized, double-blind studies done by Guler et al.  and Goyal et al.  In both these studies, 10 mg bupivacaine with fentanyl was compared to 10 mg bupivacaine with fentanyl. Guler et al.  concluded that levobupivacaine could be a good alternative to bupivacaine in cesarean section as it provided sufficient sensory block level, shorter motor block, and lesser side effects. Goyal et al.  went further to conclude that levobupivacaine with fentanyl should be the preferred alternative to bupivacaine. The present study differs from the above studies as no opioid has been combined to local anesthetic for intrathecal administration as it may not be freely available in many peripheral centers.
The present study illustrates that 10 mg of isobaric levobupivacaine or hyperbaric bupivacaine provided adequate analgesia for parturients who underwent elective cesarean section. No additional analgesic was required intraoperatively in any of the patient in this study. In a study by Gautier et al.  8 mg of levobupivacaine was founds to be less effective (lower success rate of intra operative analgesia) than 8 mg of racemic bupivacaine implying the use of a suboptimal dose of local anesthetic.
In the present study, the onset of motor block was faster and its duration longer, in parturients in Group L as compared to those in Group B. The difference was statistically significant, but clinically inconsequential as complete motor block was achieved within 12 min in all patients in the study.
In the present study, the duration of analgesia and motor block provided by levobupivacaine was significantly shorter than that provided by bupivacaine. In contrast to this, sensory and motor block characteristics were observed to be similar in many studies where equal doses of levobupivacaine and bupivacaine were compared. ,,, In patients scheduled for endoscopic transurethral surgery Vanna et al.  compared 2.5 ml of isobaric levobupivacaine with 2.5 ml hyperbaric bupivacaine and reported similar onset and duration of the sensory block with both the drugs. Glaser et al.  compared 3.5 ml of isobaric levobupivacaine to 3.5 ml of isobaric bupivacaine in patients scheduled for elective hip replacement and found those equally effective with no intergroup difference in hemodynamic or block characteristics. Similarly Fattorini et al.  compared 3 ml of isobaric levobupivacaine with bupivacaine in major orthopedic surgery and reported no significant difference in duration of sensory or motor block. Lee et al.  reported that bupivacaine and levobupivacaine have equivalent hemodynamic effects and clinical profile. In all these studies, administration of supramaximal dose of spinal anesthetic may have masked possible differences.
The difference in the motor block between the two drugs, found in the present study is similar to the results reported by Guler et al.  and Gautier et al.  They used an isobaric solution of levobupivacaine and bupivacaine in contrast to the present study where isobaric levobupivacaine has been compared to hyperbaric bupivacaine.
According to Sarvela et al.  motor block develops and disappears faster with the use of hyperbaric solutions implying the effect of baricity on block characteristics. The difference in motor block characteristics in the present study cannot be ascribed to baricity as the duration of motor block was longer in paturients receiving hyperbaric bupivacaine. The greater mean spread of hyperbaric solutions may be associated with an increased incidence of cardio respiratory side effects, although this is not always the case.  Gori et al.  suggested that isobaric levobupivacaine in CSF acts indifferently to gravitational forces, both immediately after the injection and later on. Therefore, levels of the sensory block after intrathecal isobaric levobupivacaine are unaffected by the patient position following the injection. This might be an advantage over plain bupivacaine which has the tendency to spread unexpectedly high even after a reasonable time for fixation , thus causing late complications such as hypotension and bradycardia from highblock.
In the present study, the maximum sensory block level in parturients in Group L was significantly lower than those in Group B.
As maximum block level is the most important factor influencing hemodynamic changes in intrathecal block  the lower incidence of hypotension and bradycardia found in patients in Group L than those in Group B, in the present study, is explained. These results are in accordance with the study by Guler et al.  and Fattorini et al.  In contrast, in a study comparing 10 mg hyperbaric bupivacaine, 11 mg levobupivacaine and 11 mg bupivacaine, all with 10 μg fentanyl given intrathecally for cesarean section, Sundarathiti et al.  found that there was no difference in hemodynamic parameters in any of the groups. The advantage of greater hemodynamic stability with levobupivacaine observed in the present study was possibly offset by the use of a higher dose of levobupivacaine in the above-mentioned study.
Hypotension is one of the most common complications of spinal anesthesia and it assumes greater significance in case of cesarean delivery as it may affect the fetus by decreasing placental perfusion in addition to its adverse effects on the parturient. As hypotension and a resultant decrease in cerebral blood flow is the most common cause of nausea and vomiting after regional anesthesia for cesarean section,  this can explain the lower incidence of nausea and vomiting found in Group L when compared with Group B, in the present study. Another contributing factor for an overall decreased incidence of nausea and vomiting in the present study may be that no opioid was combined with local anesthetic for intrathecal administration. Although not significant statistically, lower incidence of bradycardia and vomiting observed in parturients receiving levobupivacaine, in the present study was clinically important, and the small sample size could explain this result. Assessment of neonatal hypoxia as a consequence of maternal hypotension using cord blood arterial blood gas analysis could not be done due to nonavailability of ABG machine in the present set up. This may be true for many secondary care setups in the country.
| Conclusion|| |
It is concluded that both bupivacaine and levobupivacaine provide effective surgical anesthesia for elective cesarean section. As there was lesser duration of motorblock, independence from influence of position and decreased incidence of side effects (hypotension, bradycardia, nausea, and vomiting), observed with levobupivacaine we conclude that it can act as substitute for bupivacaine, especially in cases, where requirement for prolonged duration of block is not anticipated.
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[Table 1], [Table 2], [Table 3], [Table 4]