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临床试验/CTRI/2023/09/057943
CTRI/2023/09/057943尚未招募4 期

A prospective randomised study to evaluate the influence of epidural volume extension on spinal block with hyperbaric levobupivacaine for lower limb surgeries

M S Rmaiah medical college1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
onset & duration of sensory blockade

研究概览

简要总结

combined spinal epidural anesthesia is a  regional anesthesia technique preferred for lower limb surgeries due to its rapid onset through the spinal component and post operative pain relive through epidural component while avoiding the disadvantages of both. epidural volume extension is a modification of combined spinal epidural anesthesia where in normal saline is injected into the epidural space immedietly after the intrathecal dose as a part of CSEA so the injected volume of fluid in the epidural space causes compression of the CSF resulting in cephalad spread of local anesthetic present in the subarachnoid space. So in the present study  objective is to compare the onset and duration of sensory blockade , maximum level of sensory blockade achieved and onset and duration of motor blockade. And also to compare thr effect of hemodynamic changes like hypotension, bradycardia and other side effects like nausea, vomiting and shivering.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • all patients undergoing elective lower limb surgeries under combined spinal epidural anaesthesia who fit into american society of anaesthesiologists (ASA) physical status I and II.

排除标准

  • american society of anaesthesiologist (ASA) physical status III and above patient refusal patients in whom CSEA is contraindicated patients having allergy to drugs used in the study.

结局指标

主要结局

onset & duration of sensory blockade

时间窗: levels will be tested every minute until highest level is achieved & every 10 mins there after until 2 segment regression is achieved

maximum level of sensory blockade achieved

时间窗: levels will be tested every minute until highest level is achieved & every 10 mins there after until 2 segment regression is achieved

onset and duration of motor blockade

时间窗: levels will be tested every minute until highest level is achieved & every 10 mins there after until 2 segment regression is achieved

次要结局

  • hypotension(bradycardia)

研究者

发起方
M S Rmaiah medical college
申办方类型
Private medical college

研究点 (1)

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