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临床试验/NCT02862041
NCT02862041已完成不适用

Role of Echogenic Versus Nonechogenic Needles in Ultrasound Guided Infraclavicular Brachial Plexus Block Success Rate: A Comparative Study

Post Graduate Institute of Medical Education and Research, Chandigarh0 个研究点目标入组 60 人开始时间: 2014年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
Needle tip and shaft visibility

研究概览

简要总结

In this prospective, randomized, double blinded study, the needle tip and needle shaft visibility of echogenic and nonechogenic needle were compared in ultrasound guided infraclavicular brachial plexus block. Sixty patients scheduled for upper extremity surgery were included in the study. Patients were randomised into two groups, group E (Echogenic) and group NE (Nonechogenic) with 30 subjects in each group. Under ultrasound guidance infraclavicular brachial plexus block was performed. In Group E, Pajunk Sonoplex echogenic needle was used and in Group NE, Stimuplex Braun nonechogenic needle was used. The subjective assessment for needle tip/shaft visibility as scored by the performer and the objective assessment from the recorded block procedure video were noted.

详细描述

The aim of the investigators study was to find out the better among the echogenic and nonechogenic needle in needle tip/shaft visibility and the block success rate in ultrasound guided infraclavicular brachial plexus block. Sixty patients were randomized into two groups, Group E (echogenic group) and Group NE (nonechogenic group) with thirty patients in each group. The ultrasound imaging of each nerve block was video recorded for later analysis. Recording commenced from skin puncture and stopped at the time of final needle removal (total block time). After each block the performer was asked to subjectively score the percentage time he had visualized the needle tip and needle shaft on a 5 point scale (1 = 0%-20%, 2 = 20%-40%, 3 = 40%- 60%, 4 = 60%-80%, 5 = 80%-100%). The recorded video was later analysed by an investigator. An objective measurement of percentage needle tip visibility and needle shaft visibility was calculated for each nerve block using the formula,

Time in view (needle tip) / total block time x 100

Time in view (needle shaft) / total block time x 100

The subjective assessment for needle tip/shaft visibility as scored by the performer and the objective assessment from the recorded block procedure video were noted. Other block parameters were also compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-60 years, both male and female scheduled for upper extremity surgery

排除标准

  • Clinically significant coagulopathy
  • Local anesthetic allergy
  • Preexisting motor or sensory deficit in the operative limb
  • Uncontrolled hypertension and unstable Ischemic Heart disease
  • Body mass index > 35
  • Patients who needs general anaesthesia for surgery

结局指标

主要结局

Needle tip and shaft visibility

时间窗: Duration of Block procedure

Percentage Needle Tip \& shaft visibility calculated using the formula - Time in view (needle tip or shaft) / total block time\*100

次要结局

  • Duration of block procedure(5- 15 minutes. Start of skin puncture till the final needle removal)
  • Duration of sensory blockade(0- 6 hours. Time (Hours) between the block completion and the first pain postoperatively.)
  • Time to onset of sensory blockade(0- 15minutes. Time (Minutes) between finishing injection of Local anaesthetic and to no response to pin prick test.)
  • Time to onset of motor blockade(0- 20 minutes. Time (Minutes) between finishing injection of Local anaesthetic and onset of full paralysis.)
  • Block success rate of echogenic and Nonechogenic group.(Duration of surgery)
  • Duration of motor blockade(0- 5 hours. Time (Hours) between the full paralysis and recovery of motor functions.)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vinoth Kumar

Junior resident

Post Graduate Institute of Medical Education and Research, Chandigarh

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