The Minimum Effective Dose (ED90) of Liposomal Bupivacaine for Preserving Motor Function After Interscalene Brachial Plexus Block: a Dose-finding Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- ED90 of motor function was preserved 72 hours after brachial plexus block
研究概览
简要总结
Explore the minimum effective dose of liposomal bupivacaine for preserving motor function
详细描述
Our research group plans to conduct a dose exploration experiment, using a biased coin design sequential method to explore the 90% minimum effective dose of bupivacaine liposomes for preserving motor function after intermuscular groove brachial plexus block surgery in shoulder arthroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 41 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 41-65 years ASA physical condition 1-3 BMI 18-30 kg/m2 undergoing arthroscopic shoulder surgery
排除标准
- •Inability to consent to the study pregnancy allergy to local anesthetics preexisting neuropathy cervical pathologies (i.e., herniated disc, myelopathy) chronic pain syndromes (defined as reflex sympathetic dystrophy or complex regional pain syndrome) severe respiratory conditions psychiatric or cognitive disorders that prohibit patients from adhering to the study protocol history of drug or alcohol abuse chronic opioid use (longer than 3 months or daily morphine equivalents more than 5mg/day for 1 month) contraindication for general anesthesia and/or interscalene nerve block and planned open shoulder arthrotomies Muscle related diseases
研究组 & 干预措施
First patient's dose of bupivacaine liposome
First patient's use of bupivacaine liposome and next patient's use of bupivacaine liposome
干预措施: First patient Bupivacaine liposome and next patient Bupivacaine liposome (Drug)
next patient's dose of bupivacaine liposome
First patient's use of bupivacaine liposome and next patient's use of bupivacaine liposome
干预措施: First patient Bupivacaine liposome and next patient Bupivacaine liposome (Drug)
结局指标
主要结局
ED90 of motor function was preserved 72 hours after brachial plexus block
时间窗: 72 hours after brachial plexus block
Evaluate the effective sensory blockade for maintaining motor function at the time point
次要结局
未报告次要终点
研究者
Qing-he Zhou
Dr.
Affiliated Hospital of Jiaxing University