Clinical Trial of Ultrasound Combined With Computed Tomography Guided Lumbar Sympathetic Ganglion Block

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Pain, Chronic, Sympathetic Disorder, Ultrasound Therapy

Intervention / Treatment
-----------------
* Device: ultrasound and CT


Participation Criteria
=================
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; Pregnancy; The puncture site is infected; Coagulation dysfunction; Allergic to local anesthetic or contrast agent; Cognitive impairment or inability to provide informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ultrasound combined with CT guided<br>ultrasound combined with CT guided lumbar sympathetic ganglion block in patients with intractable pain caused by sympathetic neuropathy of lower extremities | Device: ultrasound and CT<br>* Experimental: ultrasound combined with CT guided Active Comparator: CT guided<br>|
| Sham Comparator: CT guided<br>CT guided lumbar sympathetic ganglion block in patients with intractable pain caused by sympathetic neuropathy of lower extremities | Device: ultrasound and CT<br>* Experimental: ultrasound combined with CT guided Active Comparator: CT guided<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of block | Numerical rating score（NRS） less than 4 | through study completion, an average of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The skin temperature | The skin temperature | 10 minutes | 
| The toe perfusion index | The toe perfusion index | 10 minutes | 
| The number of patients satisfied with the first angiography | The number of patients satisfied with the first angiography | immediately | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lumbar sympathetic, ultrasound