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临床试验/CTRI/2024/01/061268
CTRI/2024/01/061268招募中2 期

The effect of three different volumes of 0.5% bupivacaine on the perfusion index ratio during the ultrasound guided nerve block: A randomised controlled trial

Karnataka Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年1月15日最近更新:

试验速览

阶段
2 期
状态
招募中
入组人数
75
试验地点
1
主要终点
Observe the PI ratio before and after interscalene block following 10ml, 15ml and 20ml of 0.5% bupivacaine.

研究概览

简要总结

Perfusion index (PI) is a new and objective way to evaluate the success of peripheral nerve block.[1] It can be used as an alternate means for sensory or motor function tests.

 -       Many studies have elucidated that PI changes in increments of double or even quadraple to signify successful block.  Pardeep et al stated PI>3.2 and PI ratio of > 2.04 at 15min to be accurate predictors for block success in USG guided interscalene nerve blocks.[2]  However many studies give contrasting results with respect to the cutoff values or the ratio of PI index.

-       We hypothesize that the volume of LA used may be one of determining factor in the cutoff value of PI index for successful nerve block.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator 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

  • Adult patients of either sex aged between 18-60 years.
  • Scheduled for elective upper limb surgery (involving humerus or shoulder) under sole ultrasound guided interscalene block.
  • American society of Anesthesiologists physical status I or II.

排除标准

  • Patients with diabetes mellitus or peripheral vascular disease.
  • Allergy to local anaesthetics.
  • Local site infection
  • Refusal by patient for study.
  • Coagulopathy.

结局指标

主要结局

Observe the PI ratio before and after interscalene block following 10ml, 15ml and 20ml of 0.5% bupivacaine.

时间窗: Baseline and 15minutes

次要结局

  • The cutoff values of PI and PI ratio as predictors of successful block(Baseline and 15 minutes)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Milon Vasant Mitragotri

KARNATAKA INSTITUTE OF MEDICAL SCIENCES

研究点 (1)

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