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临床试验/NCT01667315
NCT01667315Unknown2 期

Minimum Effective Volume of 0.375% Bupivacaine in Ultrasound- and Nerve Stimulator-guided Interscalene Brachial Plexus Block for Shoulder Surgery

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
33
试验地点
1
主要终点
Minimum effective volume of 0,375% bupivacaine

研究概览

简要总结

The use of ultrasound in regional anesthesia enables reduction in the local anesthetic volume. The present study aimed to determine the minimum effective volume of 0.375% bupivacaine with epinephrine for interscalene brachial plexus block for shoulder surgery. Following approval by the Research Ethics Committee, patients with a physical condition of I or II according to the American Society of Anesthesiologists, between 21 and 65 years old and subjected to elective surgery of the shoulder and interscalene brachial plexus block will be recruited. The volume of the anesthetic will be determined using a step-up/step-down method and based on the outcome of the preceding block. Positive or negative block results in a 1mL reduction or increase in volume, respectively. The success of the block is defined as the presence of motor block in two muscle groups and the absence of thermal and pain sensations in the necessary dermatomes within 30 minutes of the injection. Diaphragmatic paralysis, pulmonary function and analgesia will be quantified at 30 minutes, 4 and 6 hours. Data will undergo statistical analysis in order to determine minimum effective volume of 0.375% bupivacaine and, secondarily, the maximum volume that maintains the diaphragmatic function, evaluate diaphragm paralysis and its influence in pulmonary function.

研究设计

研究类型
Interventional
分配方式
Na
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

  • Age between 21 and 65 years
  • Candidates for an elective surgical intervention on the shoulder with indication for anesthesia via brachial plexus block
  • Physical condition of I or II according to the American Society of Anesthesiologists
  • Body mass index up to 35 kg.m-2

排除标准

  • Chronic obstructive pulmonary disease
  • Cognitive impairment or active psychiatric condition
  • Infection at the site of the puncture for the block
  • Coagulopathy
  • Bupivacaine allergy

研究组 & 干预措施

Bupivacaine

Experimental

Bupivacaine 0,375%

干预措施: Bupivacaine 0,375% (Drug)

结局指标

主要结局

Minimum effective volume of 0,375% bupivacaine

时间窗: 30 minutes

Minimum effective volume of 0,375% bupivacaine with epinephrine in ultrasound-guided interscalene brachial plexus block for shoulder surgery

次要结局

  • Maximum 0,375% bupivacaine volume that maintains the diaphragmatic function(Before block, 10, 20 and 30 minutes, 4 and 6 hours after)
  • Pulmonary function(Before block, 30 minutes, 4 and 6 hours after)
  • Diaphragmatic Function(Before block, 30 minutes, 4 and 6 hours after)

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 Saldanha de Almeida

Principal Investigator

Federal University of São Paulo

研究点 (1)

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