NCT04445480已完成不适用
The Benefit of Popliteal Sciatic Nerve Block for Lower Limb Angioplasty in Critical Limb Ischemia: a Randomised Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of general anaesthesia
研究概览
简要总结
Endovascular revascularization is an effective procedure in treatment of chronic critical limb ischemia. The less invasive procedure in high risk patients produce the benefit to the patients. However, some of the patients cannot tolerate local anaesthesia. These patients need sedation or even general anaesthesia, which increase unnecessary risk to the patients. This study is conducted to evaluate the benefit of popliteal sciatic nerve block or popliteal block compare to sedation in critical limb patients undergoing angioplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 20 year-old with chronic ischemic limb pain
- •Scheduled for peripheral angioplasty under monitor anaesthesia care
- •Expected timing of procedure not more than 3 hours
排除标准
- •Age less than 21
- •Cannot cooperate with the staff
- •Having pain in other areas or both legs
- •Contraindicate for nerve block
- •Allergy to local anesthetic drugs or sedative drugs
结局指标
主要结局
Incidence of general anaesthesia
时间窗: Five hours
次要结局
- Numerical pain rating scale during procedure(Five hours)
研究者
研究点 (1)
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