Minimum Effective Volume of Bupivacaine 0.5% for Ultrasound-guided Retroclavicular Approach to Infraclavicular Brachial Plexus Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50)
研究概览
简要总结
In this study, the primary objective was to estimate the minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.
详细描述
Two rules were used to stop the study. First stopping rule was a fixed-sample-size. The investigators used an up-and-down method to estimate the threshold for an all-or-none response for present study design. Therefore, for sample size calculation, the investigators applied the formula by Dixon and Massey, n=2(SD/SEM)2 (SD: standard deviation and SEM: standard error of mean). Second stopping rule included demonstration of minimum of five consecutive up-and-down sequences. On the basis of previous studies with similar binary outcomes, the investigators estimated that a priori a minimum of five negative-positive up-and down deflections was required to calculate MEV50.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery
- •American Society of Anesthesiologists class I, II or III
排除标准
- •patients <18 years old
- •>65 years old
- •body mass index (BMI) <20 or >35 kg/m2
- •inability to provide written informed consent
- •refusal of regional anesthesia
- •pregnancy
- •contraindication for regional anesthesia
结局指标
主要结局
The minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50)
时间窗: 30 minutes
The determination of MEV50 and its 95% confidence interval (CI) was based on the staircase up-and-down method by Dixon and Massey
次要结局
- estimate the minimum effective volume in 95% of patients (MEV95).(30 minutes)