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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain, Chronic
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 246
- Locations
- 1
- Primary Endpoint
- The success rate of block
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The success rate of block
Time Frame: through study completion, an average of 7 days
Numerical rating score（NRS） less than 4
Secondary Outcomes
- The skin temperature(10 minutes)
- The number of patients satisfied with the first angiography(immediately)
- The toe perfusion index(10 minutes)