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临床试验/CTRI/2020/01/022714
CTRI/2020/01/022714招募中不适用

A study to find minimum effective volume of 0.5% ropivacaine for ultrasound guided costoclavicular block

all india institute of medical sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年12月5日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
to calculate mev of ropivacaine in 90% of patients for costocavicular bliock

研究概览

简要总结

The primary objective is to find the minimum effective volume of 0.5% ropivacaine  in 90% patients ( MEV90)  for ultrasound guided costoclavicular approach of infraclavicular brachial plexus block for which adults between 18 to 65 yrs undergoing hand wrist and elbow surgery  will be chosen , excluding the above mentioned categories . Then after preanaesthetic check up and explaining pain score to patients selected ultrasound guided block will be given prior to surgery . The volume of the drug will be based on baised coin method and up and down sequece in which volume of the drug for next patient is based on result of the previous . The initial volume will be 20 ml and based on the success of this the next volume will be 2ml lesser , this initial volume is based on the study done supraclavicular for MEV 50 which was 23 ml . After block application success will be assessed based on sensory and motor blockade scoring at the end of 30 min. The maximum volume decided is 25 ml to avoid drug toxicity . If the block fails then next patient will get 25 ml . A fixed minimum no of 20 positive responses will be chosen for our dose finding study. The final sample is estimated by simulations to be 52 plus/minus 2 .

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • All adults posted for surgeries of elbow , forearm , wrist and hand American society of anaesthesia grade I/II patient Body mass index 18 to 30 kg/ m sq.

排除标准

  • Patients refusal for brachial plexus block Sepsis coagulopathy Known neuropathy or injury of musculocutaneous , radial , ulnar or median nerve Known allergy to local anaesthetic drugs Abnormal neck or shoulder anatomy Previous surgery in infraclavicular fossa.

结局指标

主要结局

to calculate mev of ropivacaine in 90% of patients for costocavicular bliock

时间窗: Adequate surgical anaesthesia at 30 minutes post block assessment interval

次要结局

  • 1.Supplementation required to achieve adequate surgical anaesthesia(2.Tourniquet pain)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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