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ORIGINAL ARTICLE
Year : 2020  |  Volume : 34  |  Issue : 1  |  Page : 43-46

Comparative efficacy and safety of intrathecal ropivacaine versus intrathecal bupivacaine in patients undergoing lower abdominal surgical procedures


1 Department of Anaesthesia, Medicare General Hospital, Kotulpur, Bankura, West Bengal, India
2 Department of Anaesthesia, D. Y. Patil School of Medicine and Hospital, Navi Mumbai, Maharashtra, India

Date of Submission25-Oct-2018
Date of Acceptance19-Dec-2019
Date of Web Publication16-Apr-2020

Correspondence Address:
Dr. Varsha Vyas
Department of Anaesthesia, D. Y. Patil School of Medicine and Hospital, Navi Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijpn.ijpn_54_18

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  Abstract 

Objective: The objective of the study was to compare the efficacy and safety of intrathecal ropivacaine versus intrathecal bupivacaine as anesthetic agents in patients undergoing lower abdominal surgeries. Materials and Methods: In this prospective, randomized trial, patients (n = 60) were divided into two groups of 30 each. Group R (n = 30) received intrathecal ropivacaine 0.75%, 3 ml (isobaric), whereas Group B (n = 30) received intrathecal bupivacaine 0.5%, 3 ml (isobaric). The two study groups were compared with respect to onset, duration, and level of sensory block. The time for the onset of motor block, total duration of motor block, and postoperative side effects were also recorded. Statistical Analysis: Quantitative data and categorical data were analyzed using t-test and Chi-square test, respectively. P < 0.05 was considered statistically significant. Results: The maximum sensory level of T4 was reached in 6.7% and 13.3% of the cases of ropivacaine and bupivacaine (P = 0.68), respectively. The onset time (2.54 vs. 2.91 min; P > 0.05) and level (7.38 vs. 8.14 min; P > 0.05) of sensory block achieved were found to be similar to both the drugs. The duration of sensory block was comparable in both the study groups (321.72 vs. 301.45 min; P > 0.05), whereas the duration of motor block was significantly shorter with ropivacaine than bupivacaine (214.5 vs. 283.36 min; P < 0.05). Nonsignificant higher incidence of bradycardia (10% vs. 3.3%) and hypotension (13.3% vs. 3.3%) was observed with bupivacaine than ropivacaine. Conclusion: Intrathecal ropivacaine may be considered superior to intrathecal bupivacaine in terms of early motor recovery and similar duration of sensory block. Lower incidence of hypotension and bradycardia with ropivacaine, though apparently insignificant in this study, may indicate its better safety profile as compared to bupivacaine.

Keywords: Bupivacaine, intrathecal, ropivacaine


How to cite this article:
Adhikari P, Vyas V, Naseem S, Shelke U. Comparative efficacy and safety of intrathecal ropivacaine versus intrathecal bupivacaine in patients undergoing lower abdominal surgical procedures. Indian J Pain 2020;34:43-6

How to cite this URL:
Adhikari P, Vyas V, Naseem S, Shelke U. Comparative efficacy and safety of intrathecal ropivacaine versus intrathecal bupivacaine in patients undergoing lower abdominal surgical procedures. Indian J Pain [serial online] 2020 [cited 2020 Jul 5];34:43-6. Available from: http://www.indianjpain.org/text.asp?2020/34/1/43/282551


  Introduction Top


With its several associated limitations, including need of multiple drugs, risk of drug interactions, and a higher risk of intraoperative and postoperative complications, general anesthesia always takes a second seat wherever regional/local anesthesia is an option. Local anesthetic agents produce reversible regional anesthesia allowing surgical procedures to be associated with reduced pain and distress to the patients.[1] Subarachnoid block is the type of regional anesthesia resorted to for patients undergoing lower limb and lower abdominal surgeries.[2],[3]

Bupivacaine is a relatively older local anesthetic agent introduced more than five decades ago.[1] Compared to lidocaine, it is associated with lower incidence of transient neurological syndrome,[4] but there are concerns related to cardiovascular and central nervous system toxicity.[1],[5]

Such adverse events may occur either because of accidental injection into the blood vessel or a high dose. Because of such adverse events, there is a need for a local anesthetic agent with lesser risk of toxicity.[6]

Ropivacaine is another long-acting amide type of local anesthetic[2],[7],[8] with pharmacological properties and mechanism of action similar to bupivacaine[9] but less cardiovascular and central nervous system-related toxic effects.[7] It is, however, associated with less motor blockade than bupivacaine.[10],[11],[12],[13],[14]

Faster blockage of sensory nerve fibers than motor fibers and reduced risk of cardiac toxicity with higher doses has led ropivacaine to become a popular spinal anesthetic agent.[2] This study was done to compare intrathecal isobaric ropivacaine with isobaric bupivacaine in patients undergoing lower abdominal surgeries.

Objective

The objective of this study was to evaluate the efficacy and safety of ropivacaine versus bupivacaine as an intrathecal anesthetic agent for patients undergoing lower abdominal surgeries.


  Materials and Methods Top


In this prospective, randomized trial, 60 patients of the American Society of Anesthesiologists (ASA) physical status I and II undergoing elective lower abdominal surgeries (appendectomy, hernioplasty, herniorrhaphy, oophorectomy, and hysterectomy) were enrolled. Patients with the ASA physical status Class III or more, those refusing for the treatment, those receiving potent antiplatelets or anticoagulants, and those known to have allergy to study drugs were excluded from the study. Patients with coagulopathy, spine deformity, or local skin infections at the site of injection or those who have undergone spine surgeries were also excluded. Detailed preanesthesia checkup of all the patients posted for surgery was done. In all patients, standard monitors were attached in the operating room, and baseline parameters were recorded. Intravenous fluids were infused at room temperature and ambient temperature of the operating room 22°C–28°C. Spinal anesthesia was given in sitting position with a 25G Quincke spinal needle in the L3–L4/L4–L5 interspace (midline approach) using allocated drugs to achieve a desirable level, in accordance with the surgical procedure.

The cases were randomly allocated (sealed envelope technique) to one of the two groups, i.e., intrathecal 0.75% ropivacaine 3 mL (isobaric) or 0.5% bupivacaine 3 mL (isobaric). All patients were monitored at regular intervals for 2 h for heart rate, blood pressure, and arterial oxygen saturation (SPO2). Sensory block assessment was done by observing onset, duration, and level using pinprick test. The time of onset and total duration of motor block were also noted. The degree of motor block was assessed using a four-point Bromage score.[15] Recovery from motor blockage was defined as free movement of leg and feet (Grade 1 on Bromage scale).

Side effects (bradycardia–pulse rate <60/min, hypotension–blood pressure <100/60 mmHg, and nausea–urge to vomit) of the drugs were also noted in both the groups. The study was conducted from December 2015 to May 2017 after obtaining approval from the institutional ethics committee and taking patient consent.

Statistical analysis

Quantitative data are represented as mean and standard deviation. Categorical data are expressed as number and percentages. The t-test was used for analyzing quantitative data, whereas categorical data were analyzed using Chi-square test. A statistical significance threshold of P value was set at <0.05. All analysis was carried out using IBM SPSS version 21 (IBM Corp., Armonk, N.Y., USA).


  Results Top


A total of 60 patients were enrolled in the study. These were divided into two groups of 30 each in intrathecal ropivacaine and bupivacaine. Both the study groups were comparable with respect to mean age, height, and weight without a statistically significant difference [Table 1]. Although slight predominance of males was seen in both the groups, the difference in gender was not statistically significant [P = 1.0; [Table 1]. Similarly, there was no significant difference in the ASA physical status between the two groups (P = 1.0).
Table 1: Comparison of mean age, weight, and height in the ropivacaine and bupivacaine groups

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The maximum sensory level of T6 was reached in 2 (6.7%) and 4 (13.3%) cases who received ropivacaine and bupivacaine, respectively, whereas T7 and T8 levels were reached in 7 (23.3%) and 19 (63.3%) cases in the ropivacaine group and 4 (13.3%) and 20 (66.7%) in the bupivacaine group, respectively. No difference was observed between the study groups in terms of maximum sensory level reached [Table 2]; P = 0.68].
Table 2: Distribution of cases as per the achievement of maximum sensory level

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The onset (2.54 [0.75] vs. 2.91 [0.74] min; P = 0.059) and peak (6.38 [2.79] vs. 8.14 [2.77] min; P > 0.05) of sensory block were similar with both ropivacaine and bupivacaine, whereas the early onset of motor block was seen in bupivacaine (2.77 [0.81] vs. 3.58 [0.68] min; P < 0.05) [Figure 1].
Figure 1: Comparison of onset of sensory and motor block

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The total duration of sensory block was found to be similar in both the study groups [P > 0.05; [Table 3]. In all patients, the Bromage score of 3 was achieved.
Table 3: Comparison of mean duration of sensory and motor block of ropivacaine and bupivacaine

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The duration of motor block was significantly shorter with ropivacaine [P<0.05; [Table 3].

The duration of surgery was comparable between the study groups (ropivacaine 57.01 [7.21] vs. bupivacaine 59.17 [7.57] minutes; P = 0.20).

The mean pulse rate was comparable between the study groups at baseline (P = 0.129) and in most of the readings during the procedure; however, the difference was significant at 5-, 15-, and 90-min readings (P < 0.05). Mean systolic (P = 0.11) and diastolic blood pressures (P = 0.52) were comparable between the study groups at baseline and in most of the readings during the procedure [P > 0.05, except for 10 min; [Table 4]. SPO2 was maintained above 95% in both the groups at all times. No difference was observed between the study groups in any reading (P > 0.05).{Table 4}

The incidence of bradycardia was 1 (3.3%) and 3 (10%) in the ropivacaine and bupivacaine groups, respectively. Hypotension occurred in 1 (3.3%) and 4 (13.3%) patients in the ropivacaine and bupivacaine groups, respectively. The difference for bradycardia (P = 0.61) and hypotension (P = 0.35) between the two groups was not statistically significant. Nausea occurred in 2 (6.7%) and 3 (10%) patients in the ropivacaine and bupivacaine groups, respectively (P = 1).


  Discussion Top


Both ropivacaine and bupivacaine are effective and well-tolerated local anesthetic agents for spinal anesthesia.[16] In this study, the efficacy and safety of these agents when administered intrathecally was compared in patients undergoing lower abdominal surgeries. The mean age, height, weight, gender distribution, and ASA physical status were not significantly different between the intrathecal ropivacaine and intrathecal bupivacaine groups ensuring homogeneity of the study population between the two groups. The mean duration of surgery was also comparable. There was no significant difference between the study groups in terms of onset and peak of sensory block and achievement of maximum sensory level. The onset of motor block was earlier with bupivacaine. In contrast to most of the documented studies, in this study, the drugs (both ropivacaine and bupivacaine) used in both the study groups were isobaric. The findings of this study correlate with those of Oǧün et al.[17] who also used isobaric drugs for cesarean deliveries under spinal anesthesia. Kumar et al.[18] have, however, reported a longer onset and shorter duration of sensory and motor block with intrathecal isobaric ropivacaine as compared to isobaric bupivacaine when used for day-care knee arthroscopy.

Unlike a study conducted by Bansal et al.,[2] this study showed a significantly longer sensory block with ropivacaine as compared with intrathecal bupivacaine. The duration of motor block was shorter with ropivacaine which is in coherence with other studies.[2],[19],[20],[21] A randomized, double-blind study[22] comparing intrathecal ropivacaine–fentanyl versus bupivacaine–fentanyl for major orthopedic surgical procedures on the lower limb showed similar sensory but shorter duration of motor block with former agents than the later. Early motor recovery with ropivacaine encourages early ambulation. Greater motor sensory differentiation with ropivacaine makes it an attractive agent for patients in whom motor blockade is not desired.[21]

Cardiovascular toxicity is one of the concerns with bupivacaine when used in higher doses or accidentally injected intravascularly.[23] Ropivacaine may be a safer alternative in this regard. In this study, except at 5, 15, and 90 min, there was no significant difference in the pulse rate between the two groups. At these points, the pulse rate was lower in the bupivacaine group. The incidence of bradycardia in the bupivacaine group was numerically more than ropivacaine without significant difference between the two groups, similar to another study.[2] Hypotension is a common side effect with both intrathecal ropivacaine and intrathecal bupivacaine.[2] In our study, except at 10 min, there was no significant difference in the systolic or diastolic blood pressure between the two groups. At 10 min, systolic as well as diastolic blood pressure was lower in the bupivacaine group as compared with the ropivacaine group. The bupivacaine group was associated with a numerically higher incidence of hypotension without a significant difference between the two groups. Mean arterial pressure and SPO2 did not differ in the study groups at any time point. In another study,[2] incidence of hypotension was significantly more, whereas bradycardia was numerically higher with bupivacaine than ropivacaine.

Bupivacaine is more lipophilic as compared with ropivacaine. Lesser lipophilicity is associated with reduced risk of cardiovascular toxicity with ropivacaine.[22] Overall, because of greater margin of safety than bupivacaine,[2] ropivacaine can be preferred agent for spinal anesthesia in patients undergoing surgeries of the lower limb and abdomen.

Small sample size and single-center trial are the limitations of our study. Further larger randomized studies are needed to confirm observations of our study.


  Conclusion Top


Intrathecal ropivacaine is superior to bupivacaine in terms of early motor recovery with a similar duration of sensory block, an advantage which encourages early ambulation. Greater hemodynamic stability was observed in the ropivacaine group. Based on these findings, 0.75% ropivacaine (isobaric) may be preferred over 0.5% bupivacaine (isobaric) for subarachnoid block, especially in cases where early ambulation is desired.

Acknowledgment

The authors of this study wish to thank Dr. Anant Patil for his assistance in preparing the manuscript.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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Bansal S, Ramdev B, Narula P, Bansal S, Kaur D, Rathi S. Comparative evaluation of intrathecal hyperbaric ropivacaine versus intrathecal hyperbaric bupivacaine in elective lower abdominal and lower limb surgery. IOSR J Dent Med Sci 2015;14:27-31.  Back to cited text no. 2
    
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