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临床试验/NCT01244932
NCT01244932已完成2 期

Determination of the Minimum Effective Volume of Local Anesthetic Using Ultrasound Guidance for Interscalene Brachial Plexus Block

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2009年9月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
33
试验地点
2
主要终点
ED95 of bupivacaine minimum effective volume

研究概览

简要总结

The purpose of this study is to determine the minimum effective volume of local anesthetic for interscalene brachial plexus block using ultrasound guidance and nerve stimulator guidance.

详细描述

This will be a single group assignment, double-blind, up-down sequential allocation study. Interscalene brachial plexus block (ISBPB) is a common nerve block given to patients who are undergoing shoulder surgery. This block has a low, but still significant, rate of complications. Reducing the volume of local anesthetic given during the block may allow some of these complications to be avoided. Participants will undergo ISBPB under ultrasound and nerve stimulator guidance. Patients will initially receive 15mL of local anesthetic (bupivacaine 0.5% with epinephrine). The volume used for each subsequent patient depends upon the success or failure of the previous patient's block - a failure will cause the volume given to increase by 1.0 mL, while a success will cause the volume to decrease by the same amount.

The goal of this study is to determine the minimum effective anesthetic volume of bupivacaine 0.5% providing anesthesia in patients when using ultrasound and nerve stimulator to guide placement of the block. The secondary outcome will be the evaluation of diaphragmatic function and post-surgery analgesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients receiving interscalene brachial plexus block for shoulder surgery
  • Age between 21 and 65 years
  • ASA physical status I/II
  • Body mass index < 35 kg/m2

排除标准

  • Chronic obstructive pulmonary disease
  • Psychiatric history
  • Allergy to bupivacaine
  • Infection in the site of block
  • Coagulation disorders

结局指标

主要结局

ED95 of bupivacaine minimum effective volume

时间窗: ED95

The ED95 of bupivacaine minimum effective volume determination in interscalene brachial plexus block using ultrasound guidance. \[ Time Frame: every 10 minutes until 30 minutes, after 4 hours and after 6 hours post-block \]

次要结局

  • Diaphragmatic Function(Diaphragmatic)
  • Post-surgery analgesia(Analgesia)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luiz Fernando dos Reis Falcao

Ph.D.

Federal University of São Paulo

研究点 (2)

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