跳至主要内容
临床试验/NCT04445480
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

Mahidol University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年5月7日最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验