跳至主要内容
临床试验/NCT06677697
NCT06677697已完成4 期

Comparative Study of 0.5% Bupivacaine and 0.5% Ropivacaine in Per Operative Continuous Lumber Epidural Anaesthesia of Lower Limb Bypass Surgery

ibrahim cardiac hospital and research institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
compare the efficacy of drug

研究概览

简要总结

Regional anaesthesia is an important part in clinical anaesthesiology now a day. Epidural block is a commonly used regional technique alternative for general anaesthesia in case of lower limb bypass surgery. Bupivacaine and Ropivacaine both are amide local anaesthetics. This study was to compare the efficacy of 0.5% Bupivacaine with 0.5% Ropivacaine in lumber epidural block for lower limb bypass surgery. The aim of the study was to compare the hemodynamic changes and adverse effects between the two groups and the onset of sensory and motor blockade in lower limb bypass surgery.

Material and method: Sixty(60) patients with American Society of Anaesthesiologists class II/III scheduled for elective lower limb bypass surgeries were randomly allocated into two groups .Group B received 0.5% Bupivacaine, and group R received 0.5% Ropivacaine for epidural anaesthesia at the level of L4 & L5. The onset of sensory and motor block and adverse events during the peroperative period were noted.

详细描述

Introduction:

Epidural anaesthesia has been found to be a well-known technique for lower limb bypass surgeries as it provides effective sensory and motor blockade in an awake patient for longer duration. Moreover, Epidural anaesthesia provides better control of pain and satisfactory analgesia in postoperative period without any respiratory complications. Bupivacaine & Ropivacaine both are amide local anaesthetics. Bupivacaine being more cardiotoxic there has been paradigm shift to ropivacaine which is less cardiotoxic and widely used in epidural and spinal anaesthesia to obtain intraoperative and postoperative pain relief with lesser side effects. It has been seen that ropivacaine blocks the sensory fibres more effectively as compared to the motor fibre. In addition; ropivacaine has been shown to have vasoconstrictor properties.

Our goal in this prospective, single blind, randomized study was to compare the anaesthetic characteristics of 0.5% Ropivacaine with that of 0.5% Bupivacaine when administered epidurally for lower limb bypass surgery.

Materials & Methods

This randomized single-blind study was conducted from 1st January '2021 to 31st December '2022 at the department of Anaesthesiology, Ibrahim Cardiac Hospital and Research Institute, Shahbagh, Dhaka, Bangladesh. After institutional ethical committee approval and informed written consent, a total number of 60 adult patients were randomly allocated into two groups (n=30) using a computerized random number table. Patients with ASA physical status II & III, aged between 30 and 60 years, scheduled for lower limb bypass surgeries were enrolled in this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sixty patients who underwent lower limb surgery -

排除标准

  • non operative patients

研究组 & 干预措施

Group B 30 participant received 0.5% rupivacaine

Experimental

Group B 30 participant received 0.5% rupivacaine

干预措施: Ropivacaine 0,5% (Drug)

结局指标

主要结局

compare the efficacy of drug

时间窗: 6 months

compare the efficacy of 0.5% Bupivacaine with 0.5% Ropivacaine in lumber epidural block for lower limb bypass surgery.

次要结局

未报告次要终点

研究者

发起方
ibrahim cardiac hospital and research institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raju Ahmed

Associate Professor

ibrahim cardiac hospital and research institute

研究点 (1)

Loading locations...

相似试验