Clinical Trial of Ultrasound Combined With Computed Tomography Guided Lumbar Sympathetic Ganglion Block for the Safety and Efficacy of Patients With Refractory Pain Caused by Sympathetic Neuropathy of Lower Extremities
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- The success rate of block
研究概览
简要总结
To evaluate the safety and efficacy of ultrasound combined with CT-guided sympathetic ganglion block for refractory pain caused by sympathetic neuropathy of the lower extremities.
详细描述
To evaluate the safety and efficacy of ultrasound combined with CT-guided sympathetic ganglion block for refractory pain caused by sympathetic neuropathy of the lower extremities. Patients with lumbar sympathetic block were enrolled and randomized to a conventional CT-guided group and an ultrasound-guided CT-guided group. By comparing the traditional CT guided and ultrasound combined with CT guided two programs, the radiation dose, block success rate, treatment time, etc. received by patients with lumbar sympathetic block were observed to understand whether ultrasound combined with CT guidance is a way to reduce radiation exposure. Under the premise of the dose, the method of blocking the success rate can still be guaranteed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18~80 years old; 2.Pain disorders requiring lumbar sympathetic block（Such as,Lower limb vascular disfunction,Diabetic polyneuropathy,Postherpetic neuralgia,Complex regional pain syndrome I and II,Cancer related neuropathic pain including Peripheral neuropathy caused by chemotherapy or other lower extremity sympathetic neuropathy）,conservative treatment for 3 months or longer can not be cured; 3.Numerical rating score≥4.
排除标准
- •Body mass index> 30 kg / m2;
- •History of internal fixation in posterior lumbar laminectomy or any serious anatomic variation, such as scoliosis and tumors;
- •History of lumbar sympathetic neurochemistry or thermal neurolysis;
- •The puncture site is infected;
- •Coagulation dysfunction;
- •Allergic to local anesthetic or contrast agent;
- •Cognitive impairment or inability to provide informed consent.
结局指标
主要结局
The success rate of block
时间窗: through study completion, an average of 7 days
Numerical rating score（NRS） less than 4
次要结局
- The skin temperature(10 minutes)
- The number of patients satisfied with the first angiography(immediately)
- The toe perfusion index(10 minutes)