Minimum Effective Volume of Bupivacaine for Retroclavicular Approach Brachial Plexus Block
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The minimum effective volume of bupivacaine 0.5% resulting in successful block in 90% of patients (MEV90)
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 90% of patients (MEV90) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.
详细描述
A "biased coin up-and-down sequential design" will be applied to assess the minimum effective volume in 90% of patients for the retroclavicular brachial plexus block. The first subject received 25 ml 0.5% bupivacaine . Each subsequent patient received a dose that depended on the response of the previous one. If the previous block is successful, the block will be performed either by a reduction of the volume by 2.5 ml with a probability ß = 0.11 or by a same dose of the previous one with a probability 1-ß = 0.89 in the next patient.
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 90% of patients (MEV90)
时间窗: 30 minutes
The determination of MEV90 and its 95% confidence interval (CI) will be based on a "biased coin up-and-down sequential design
次要结局
未报告次要终点