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 Table of Contents  
ORIGINAL ARTICLE
Year : 2019  |  Volume : 6  |  Issue : 1  |  Page : 16-20

Intraoperative and postoperative effects of different doses of bupivacaine: a comparative and prospective study for lower limbs surgeries


Department of Anaesthesia, Ahmadu Bello University Teaching Hospital, Shika, Zaria, Kaduna State, Nigeria

Date of Web Publication10-Oct-2019

Correspondence Address:
Dr. Yunus A Gafar
Department of Anaesthesia, Ahmadu Bello University Teaching Hospital Shika, Zaria, Kaduna State
Nigeria
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ssajm.ssajm_11_19

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  Abstract 


Background Central neuraxial block is the gold standard for surgeries below the level of the umbilicus, especially for lower limb operations. Bupivacaine of different concentrations are used for regional blocks and the side effects are attributed to the concentration of the local anaesthetics used.
Objective The aim of this study was to prospectively investigate the intraoperative and postoperative effects of different doses of bupivacaine in lower limb surgeries.
Methodology A double-blind randomized controlled study was conducted on 120 patients scheduled for emergency lower limb surgeries at Ahmadu Bello University Teaching Hospital from January to December 2017. The patients were randomly grouped into two groups: 1 and 2. The patients in group 1 received 10 mg of 0.5% bupivacaine and 10 μg of fentanyl, whereas those in group 2 received 7.5 mg of 0.5% bupivacaine and 10 μg of fentanyl. Parameters considered included the hemodynamic indices, quality of intraoperative analgesia, onset time of sensory and motor blockade, level of sensory and motor blockade, and duration of the sensory and motor blockade. A P value less than 0.05 was considered statistically significant.
Results There was no statistically significant difference (P < 0.05) in the demographic, American Society of Anesthesiologists (ASA) parameters, time of onset of sensory block, and duration of sensory block. There was statistically significant difference in duration of motor blockade, with time of first analgesic request, and more hypotension recorded in group 1 compared to group 2.
Conclusion This study has established that 7.5 mg of 0.5% bupivacaine with 10 μg fentanyl has operative analgesia of equal efficacy as 10 mg of 0.5% bupivacaine.

Keywords: Fentanyl, heavy bupivacaine, lower limb surgeries, subarachnoid blocks


How to cite this article:
Gafar YA, Yusuf B, Ganiyat O, Yunus A. Intraoperative and postoperative effects of different doses of bupivacaine: a comparative and prospective study for lower limbs surgeries. Sub-Saharan Afr J Med 2019;6:16-20

How to cite this URL:
Gafar YA, Yusuf B, Ganiyat O, Yunus A. Intraoperative and postoperative effects of different doses of bupivacaine: a comparative and prospective study for lower limbs surgeries. Sub-Saharan Afr J Med [serial online] 2019 [cited 2023 Jan 28];6:16-20. Available from: https://www.ssajm.org/text.asp?2019/6/1/16/268783




  Introduction Top


Central neuraxial blockade is the gold standard for surgeries below the level of the umbilicus, especially for lower limb operations. Bupivacaine of different concentration are used for regional blocks and the side effects are attributed to the concentration of the local anesthetics used. Opioids are frequently added as adjuncts to local anesthetics to enhance the duration of postoperative analgesia. Opioids have varying side effects, such as nausea, vomiting, pruritus, respiratory depression, and urinary retention.[1] Low-dose opioids and low-dose local anesthetics are combined to prevent the unwanted effects of each agent. Opioids added to local anesthetics decrease the dose requirement and provide prolonged postoperative analgesia.[2],[3],[4] Although with varying effects, agents such as ketamine, clonidine, and midazolam are used as adjuncts to local anesthetics.[5] These agents cause sensory and motor blockade by blocking neuronal calcium channels.[6],[7],[8] This study aimed to compare different doses of bupivacaine in postoperative pain management. It has been established that the concentration and dose of local anesthetic used in a given procedure is directly proportional to the side effects.[9] Therefore, the purpose of this study was to evaluate the effectiveness of two different doses of 0.5% bupivacaine, 10 and 7.5 mg, as local anesthetics for lower limb surgeries.


  Patients and methods Top


Selection and description of participants

This was a prospective, double-blinded and randomized study conducted on 120 emergency patients scheduled for lower limb surgeries at Ahmadu Bello University Teaching Hospital from January 2017 to December 2018. Patients (adults of both sexes) were randomly allocated into groups 1 and 2. Randomization was done by a computer-generated random numbers using PEPI-for-Windows (WINPEPI, v.4.0. Salt Lake City, Utah: Sagebrush Press USA). Patients in group 1 received 10 mg of 0.5% bupivacaine (Celon Laboratories Pvt Ltd, Hyderabad, India) and 10 μg of fentanyl whereas those in group 2 received 7.5 mg of 0.5% bupivacaine and 10 μg of fentanyl (Noramco, TX, USA). Both groups had 10 μg of fentanyl added to bupivacaine administered into the subarachnoid space. Parameters considered included the hemodynamic indices (blood pressure and heart rate), quality of intraoperative analgesia, onset time of sensory and motor blockade, level of sensory and motor blockade, and duration of the sensory and motor blockade. The instrument used to monitor hemodynamic indices was Dash-4000 general electric multiparameter automated monitor (GE Healthcare, MA, USA).

Study design

The demographic data of the patients were recorded. The hemodynamic indices were initially measured digitally every 3 minutes of the first 20 minutes, and every 5 minutes throughout the length of the surgery, using the Dash-4000 general electric multiparameter automated monitor. The anesthetic agent (combination of bupivacaine and fentanyl) were administered into the subarachnoid space. The onset and level of the sensory blockade were assessed using cotton wool soaked in methylated spirit. The motor blockade was assessed using the modified Bromage[10] scale [Table 1] and the duration of the motor blockade (from the onset of no limb movement to when the patient was able to move the limb). The quality of analgesia was assessed at intervals of 10 minutes using four-point scale [Table 2]. The administration of the different doses of bupivacaine and the assessment were carried out by designated senior registrars, not involved in administering treatment to the patient or having knowledge of the study. This was aimed at eliminating any form of bias.
Table 1 Modified Bromage score

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Table 2 Quality of intraoperative analgesia (four-point scale)

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In a case of major discomfort that may warrant additional analgesia, we planned to give supplemental analgesics: a combination of ketamine and diazepam/midazolam. But where administration of ketamine was contraindicated, we converted to general anesthesia.

The primary outcome, which is the time to first analgesic request, was taken from the time of maximum sensory block until the patient’s first request for analgesic. Hypotension was corrected with intravenous ephedrine at incremental dose of 6 mg with maximum dose of 30 mg, in addition to increasing the rate of flow of the intravenous fluid.

Ethical consideration

Ethical approval (ABUTH/HREC/E25/2019) for this study was given by Ahmadu Bello University Teaching Hospital Zaria ethics committee. Informed consent was also obtained from all eligible candidates recruited for this study. The study was conducted in accordance with the International Conference on Harmonization − Good Clinical Practice, an ethical code of conduct that was laid out by the Declaration of Helsinki.

Statistics

The data obtained were expressed as mean ± standard error of mean using Student’s t test. Data analysis was done using Statistical Package for Social Sciences (SPSS, IBM, USA, v.18) version 18. P value of >0.05 was considered statistically not significant whereas P value <0.05 was considered statistically significant.


  Results Top


The patients’ demographic data, gender, and their American Society of Anesthesiologists (ASA) classes are presented in [Table 3]. The mean age difference of patients in the two groups was statistically significant (P > 0.05). Patients in group 1 had a mean age of 30.38 ± 8.35 whereas patients in group 2 had mean age of 28.93 ± 5.44. Most of the patients in both the groups were of ASA class 2E. Patients in both the groups had a modified Bromage score of grade 3, as seen in [Table 4]. [Table 5] presents the assessment time of onset and duration of block and first analgesic request. There was no statistically significant difference (P < 0.05) in the parameters assessed between the two groups. The hypotensive effects of subarachnoid block were observed in 23.3% of the patients in group 1 whereas it was 15% for patients in group 2 [Table 5].
Table 3 Demographic data and ASA assessment

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Table 4 Bromage scale for the quality of the analgesia

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Table 5 Time of onset and duration of blocks with first analgesic request

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  Discussion Top


We set out to evaluate the effectiveness of two different doses, 10 mg of 0.5% and 7.5 mg of 0.5% bupivacaine as local anesthetics in achieving prolonged analgesia for lower limb surgeries. Bupivacaine is used as local anesthetic for nerve blocks, but is characterized by acute and life-threatening cardiotoxicity.[11],[12] In our center, bupivacaine is still used but to minimize the associated side effects, we undertook this comparative different dose study.

From the results, there was no significant difference in the demographic and ASA parameters as shown in [Table 3]. Also, there was no significant difference in time of onset of sensory block and duration of sensory block. However, there was statistically significant difference (with P value of 0.018) in duration of motor blockade in group 1 that received 10 mg of 0.5% bupivacaine compared to those in group 2 that received 7.5 mg of 0.5% bupivacaine. The time of first analgesic request in group 1 was also statistically significant with P value of 0.018 as seen in [Table 5]. In a similar study,[13] the onset of adequate analgesia and achievement of maximum of sensory block was comparable in all the three groups: A (subarachnoid block with 0.5% hyperbaric bupivacaine 10 mg, fentanyl 25 µg, and 0.9% normal saline 1.5 mL), B (subarachnoid block with 0.5% hyperbaric bupivacaine 12.5 mg, fentanyl 25 µg, and 0.9% normal saline 1 mL), and C (subarachnoid block with 0.5% hyperbaric bupivacaine 15 mg, fentanyl 25 µg, and 0.9% normal saline 0.5 mL). In their study, time taken to achieve maximum upper level of sensory block was more in group A (14.00 ± 4.35 min) as compared to group C (12.00 ± 3.75 min), but there was no significant difference between groups A and B and groups B and C. This is in agreement with our study in which there was no statistically significant difference between groups 1 and 2 for onset of sensory blockade time. Also, they reported that duration of sensory block was prolonged in group C (139.50 ± 16.05 min) as compared to group A (129.00 ± 18.32 min). However, there was no statistically significant variation seen between groups A and B or B and C or A and C. Our finding was also in line with a report that observed the intensification as well as prolongation of duration of sensory block without increasing the intensity of motor block.[14] In our finding, there was statistically significant difference in duration of motor blockade in groups 1 and 2. In our study, patients in group 1 had more duration of motor block (180.02 ± 30.03) compared to those in group 2 (177.1 ± 33.8). The desired result was achieved irrespective of the differences in the duration.

In this study, we observed that the time of first request of analgesic was longer (264.15 ± 34.4) in group 1 that received 10 mg of 0.5% bupivacaine compared to the lesser time (258.3 ± 36.2) for those in group 2 that received 7.5% of 0.5 bupivacaine. Sharan et al.[13] reported that the time of request of analgesia and duration of effective analgesia in their study was slightly less in group A patients (with 10 mg bupivacaine) but the difference was statistically insignificant in comparison with the other two groups (P > 0.10). But 25 µg fentanyl prolonged the duration of postoperative analgesia to same extent in all the three groups. In relation to our study, their finding is in agreement with the overall finding we reported, which is that lower dose of bupivacaine achieves the desired analgesia for lower limb surgeries. In our studies, fentanyl was very central in achieving the desired prolongation of spinal analgesia. Similar report was given in a study that observed the prolongation of postoperative analgesia with addition of fentanyl in bupivacaine for spinal anesthesia.[15],[16] Similar results were obtained by Kuusniemi et al.[17] who found that addition of 25 µg fentanyl in 5 mg bupivacaine resulted in short-lasting motor block as compared to larger doses of bupivacaine (7.5–10 mg). This implies that recovery from spinal anesthesia gets prolonged as dose of bupivacaine is increased with fixed dose of fentanyl while duration of analgesia remained similar.[17]

During the course of this study, it was observed that more hypotension was recorded in group 1 compared to group 2 that was statistically significant with P value of 0.036 [Table 5]. Thus, 10 mg of 0.5% bupivacaine is associated with high risk of hypotension, unlike 7.5 mg of 0.5% bupivacaine. Minimum doses of local anesthetic used with substantially no risks for systematic effect should be advocated.[18],[19]

Interestingly, as shown in [Table 6], the hypotensive effects of subarachnoid block were observed in 23.3% of the patients in group 1, whereas it was 15% for patients in group 2. The implication is that there is a higher risk of hypotensive effects associated with 10 mg of 0.5% bupivacaine compared to 7.5 mg of 0.5% bupivacaine. In the developed world, ropivacaine has replaced bupivacaine.[20] In a low-resource setting with challenges of ready availability of evolved agents, efforts are made to minimize the dose of bupivacaine, while maintaining effectiveness and minimizing the side effects. It can be inferred that with 7.5 mg of 0.5% bupivacaine, the mean time for complete motor recovery would be shorter compared with a high dose. Technically, findings in this study is in agreement with the report by Mann et al.[21] that the low doses of levobupivacaine used for lower limb arthroplasty are insufficient.There was an indication that 7.5 mg of 0.5% bupivacaine has operative analgesia of equal efficacy as 10 mg of 0.5% bupivacaine, meaning that the desired analgesia is achievable with 7.5 mg of 0.5% bupivacaine in patients scheduled for lower limb surgery.
Table 6 Hypotensive effects of subarachnoid block

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  Conclusion Top


This study has established that 7.5 mg of 0.5% bupivacaine with 10 µg fentanyl have both intraoperative and postoperative analgesia of equal efficacy as 10 mg of 0.5% bupivacaine. Low dose of 7.5 mg of 0.5% bupivacaine with 10 µg fentanyl can achieve the desired analgesia for lower limb surgery with insignificant hypotension. We therefore recommend the use of a low dose of 7.5 mg of 0.5% bupivacaine for lower limb surgeries.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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Leone S, Di Cianni S, Casati A, Fanelli G. Pharmacology, toxicology, and clinical use of new long acting local anesthetics, ropivacaine and levobupivacaine. Acta Biomed 2008;79:92-105.  Back to cited text no. 12
    
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Sharan R, Jarewal V, Singh H, Attri JP. Comparative evaluation of intrathecal fentanyl with different doses of bupivacaine on lower limb surgery. Int J Med Res Rev 2018;6:3-9.  Back to cited text no. 13
    
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Ben-David B, Maryanovsky M, Gurevitch A, Lucyk C, Solosko D, Frankel R et al. A comparison of mini dose lidocaine-fentanyl and conventional-dose lidocaine spinal anesthesia. Anesth Analg 2000;91:865-70.  Back to cited text no. 14
    
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Kuusniemi KS, Pihlajamäki KK, Pitkänen MT, Helenius HY, Kirvelä OA. The use of bupivacaine and fentanyl for spinal anesthesia for urologic surgery. Anesth Analg 2000;91:1452-6.  Back to cited text no. 17
    
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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