Median Effective Concentration of Ropivacaine for Ultrasound-guided Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Median effective anesthetic concentration 90 (MEAC 90)
研究概览
简要总结
The purpose of this study was to determine the minimum effective dose of a local anesthetic for proper anesthesia for popliteal sciatic nerve block under ultrasound guidance in patients undergoing surgery for diabetic foot disease.
详细描述
Unlike general patients, patients with diabetic foot disease often have diabetic neuropathy and thus have increased sensitivity to local anesthetics. Therefore, when performing sciatic nerve block, it is essential to properly adjust the dose to prevent neurotoxicity and delay in recovery due to local anesthetics.
If the appropriate effective dose of local anesthetic for sciatic nerve block is found in patients with diabetic foot through this study, it is expected that it will be a useful basis for establishing a safe anesthetic method in the case of diabetic foot surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who can be operated under popliteal sciatic nerve block among patients undergoing surgery for diabetic foot disease
排除标准
- •Infection of the popliteal region
- •Severe coagulation abnormality
- •Allergic reaction or hypersensitivity to local anesthetics
- •Neurological abnormalities other than diabetic neuropathy in the lower extremity of the operation site
- •When it is impossible to evaluate sensory blockage and motor blockage
- •When the patient refuses
结局指标
主要结局
Median effective anesthetic concentration 90 (MEAC 90)
时间窗: within 30 minutes from the popliteal sciatic block
Concentration of ropivacaine required for successful sciatic nerve block in 90% of all patients
次要结局
- Motor block onset time(within 30 minutes from the popliteal sciatic block)
- Block duration(within 24 hours post-operatively)
- Any adverse events(within 24 hours post-operatively)
- Time to first rescue analgesia(within 24 hours post-operatively)
- Median effective anesthetic concentration 50 (MEAC 50)(within 30 minutes from the popliteal sciatic block)
- Sensory block onset time(within 30 minutes from the popliteal sciatic block)
研究者
Seokha Yoo
Clinical Assistant Professor
Seoul National University Hospital