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临床试验/NCT03190551
NCT03190551已完成不适用

A Randomized Controlled Trial Comparing Retroclavicular and Costoclavicular Approach for Infraclavicular Brachial Plexus Block

Antalya Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1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
试验地点
2
主要终点
Needle shaft visibility

研究概览

简要总结

The primary aim of this study is to compare needle shaft visibility between the retroclavicular approach and costoclavicular approach for infraclavicular brachial plexus block in patients undergoing elective upper limb surgery. Secondary aim is to investigate the differences between the two groups in sensorial block success rate, block performance time, block performance related pain, motor block success rate, surgical success rate, complications, patient satisfaction, use of supplemental local anesthetic, use of analgesic.

详细描述

Infraclavicular blocks are performed with different approaches. This study evaluated the effectiveness, safety and feasibility of a retroclavicular brachial plexus block as compared with costoclavicular approach for infraclavicular brachial plexus block. 60 patients scheduled for elective upper limb surgery were recruited and randomized into two groups: Retroclavicular approach for infraclavicular block (Group I), costoclavicular approach for infraclavicular block (Group R). Sensory block, adverse effects and complications were evaluated and recorded every 5 minutes until 30 min after local anesthetic injection. Success rate of each nerve sensory block, complications, rate of satisfaction, rate of failure and incidence rate of adverse effects, the needle shaft visibility, procedure time,duration of the block's effect, use of supplemental local anesthetic, use of analgesic are compared with both groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who undergo elective forearm or hand surgery under infraclavicular brachial plexus block
  • American Society of Anesthesiologists class 1 to 3
  • Ability to consent

排除标准

  • History of allergic reaction to local anaesthetics
  • Peripheral neuropathy
  • Renal or hepatic insufficiency
  • Coagulation disorders

结局指标

主要结局

Needle shaft visibility

时间窗: 10 minutes after the needle inserted the skin

Needle visibility reviewed by two anesthesiologists using a 5-point Likert scale

次要结局

  • Patient satisfaction using a visual analogue scale(Assessed 24 hours after the block)
  • motor block success rate(Assessed 40 minutes after block completion)
  • complications such as pneumothorax, hemothorax, intraarterial injection, intravenous injection(24 hours)
  • Success Rate of the sensorial Block(Assessed 30 minutes after block completion)
  • Block performance related pain(10 minutes after the needle inserted the skin)
  • Technique duration(Time required in seconds for the block completion (10 minutes))
  • supplemental analgesic used(90 minutes after block completion)

研究者

发起方
Antalya Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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