跳至主要内容
临床试验/CTRI/2021/01/030527
CTRI/2021/01/030527尚未招募不适用

Minimum Effective Volume (MEV 90) of 0.5% Ropivacaine for Ultrasound guided Costoclavicular Block.

VMMC and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年2月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Minimum Effective Volume of 0.5% Ropivacaine is calculated by titrating the volume of the drug according to block success or failure in previous patient.Block Success is when Minimal Composite score of 14 out of 16 points achieved(Total Composite score is 16;8 for Sensory and 8 for Motor blockade)Onset of Sensory blockade assessed by cold test(0 no block,1 Analgesia-can feel touch not cold,2 Anaesthesia-cannot feel touch)and Motor blockade by a 3 point scale(0 no block,1 paresis,2 paralysis)

研究概览

简要总结

The purpose of this prospective interventional study is to evaluate the Minimum effective volume of 0.5 % Ropivacaine for Ultrasound guided Costoclavicular block by starting with a defined volume of drug (20 ml)and titrating according to block success(reducing 2 ml for next patient) and block failure(increasing 2 ml for the next patient)

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

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 Elbow Forearm Wrist and Hand surgeries ASA grade I/II Body Mass Index 18 to 35 kg /m 2.

排除标准

  • Sepsis or Infection at the site of Injection Pre-existing Peripheral Neuropathy and Coagulation disorder Known Allergy to Local Anaesthetic drugs.

结局指标

主要结局

Minimum Effective Volume of 0.5% Ropivacaine is calculated by titrating the volume of the drug according to block success or failure in previous patient.Block Success is when Minimal Composite score of 14 out of 16 points achieved(Total Composite score is 16;8 for Sensory and 8 for Motor blockade)Onset of Sensory blockade assessed by cold test(0 no block,1 Analgesia-can feel touch not cold,2 Anaesthesia-cannot feel touch)and Motor blockade by a 3 point scale(0 no block,1 paresis,2 paralysis)

时间窗: 8 time points:time 1, immediately after the procedure;time 2,five minutes after completion of the procedure;time 3,ten minutes after the procedure;time 4, fifteen minutes after the procedure;time 5, twenty minutes after the procedure;time 6, twenty five minutes after the procedure;time 7,thirty minutes after the procedure,time 8,thirty five minutes after the procedure

次要结局

  • To assess the Onset time of blockade(time from the injection of LA to achieving a Minimal Composite score of 14)and block performance time(Sum of Imaging time-Time interval between contact of USG probe and getting a satisfactory picture plus needling time-From Start of Skin wheal to the end of Local Anaesthetic injection)(8 time points:time 1, immediately after the procedure;time 2,five minutes after completion of the procedure;time 3,ten minutes after the procedure;time 4, fifteen minutes after the procedure;time 5, twenty minutes after the procedure;time 6, twenty five minutes after the procedure;time 7,thirty minutes after the procedure,time 8,thirty five minutes after the procedure)

研究者

发起方
VMMC and Safdarjung Hospital
申办方类型
Government medical college

研究点 (1)

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