跳至主要内容
临床试验/CTRI/2019/01/017316
CTRI/2019/01/017316已完成不适用

Minimum effective volume of 0.5% Ropivacaine for Ultrasound Guided Costoclavicular block: A dose finding study

PGIMER Chandigarh1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月2日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
To determine the minimum effective volume of 0.5% Ropivacaine required to produce a successful Costoclavicular brachial plexus block for surgical anaesthesia in 50% of the patients ( MEV 50).

研究概览

简要总结

Purpose of study is to determine the minimum effective volume of 0.5% required to produce a successful Ultrasound Guided Costoclavicular block for surgical anaesthesia in 50% of patients (MEV 50).

Sample size is 40. The volume of drug will be determined using the small sample up and down sequential allocation study design of binary response variables as described by Saranteas et al. The stopping rules will include a fixed sample size and demonstration of 5 consecutive up and down sequences.

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 60.00 Year(s)(—)
性别
All

入选标准

  • ASA 1-2 BMI WITHIN 18-30 kg/m2 Forearm and hand surgeries.

排除标准

  • Local infection at block site sepsis obesity (BMI>30) Coagulopathy Allergy to local anaesthetic Renal or hepatic dysfunction Pre- existing neurological deficits Prior surgery in the infraclavicular space Psychiatric illness Patients who fail to understand the scoring systems used in the study Uncontrolled hypertension or ischaemic heart disease Refusal to give consent for the study or block.

结局指标

主要结局

To determine the minimum effective volume of 0.5% Ropivacaine required to produce a successful Costoclavicular brachial plexus block for surgical anaesthesia in 50% of the patients ( MEV 50).

时间窗: Following block administration, evaluation of sensory and motor block will be performed every 5 min until 30 minutes.

次要结局

  • 1Block onset time.(2. Block performance time.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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