Minimum Effective Volume of 0.375% Bupivacaine in Ultrasound- and Nerve Stimulator-guided Interscalene Brachial Plexus Block for Shoulder Surgery
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
- 否
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
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
Luiz Fernando Saldanha de Almeida
Principal Investigator
Federal University of São Paulo
