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

Not Applicable

• Conditions: Pain, Chronic; Ultrasound Therapy; Sympathetic Disorder
• Interventions: Device: ultrasound and CT

• Registration Number: NCT04167956
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-19
• Status Verified: 2020-01
• Study Start: 2020-10-15
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-28
• Primary Completion: 2021-10-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 246

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

1. Body mass index> 30 kg / m2;
2. History of internal fixation in posterior lumbar laminectomy or any serious anatomic variation, such as scoliosis and tumors;
3. History of lumbar sympathetic neurochemistry or thermal neurolysis;
4. Pregnancy;
5. The puncture site is infected;
6. Coagulation dysfunction;
7. Allergic to local anesthetic or contrast agent;
8. Cognitive impairment or inability to provide informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasound combined with CT guided	ultrasound and CT	ultrasound combined with CT guided lumbar sympathetic ganglion block in patients with intractable pain caused by sympathetic neuropathy of lower extremities
CT guided	ultrasound and CT	CT guided lumbar sympathetic ganglion block in patients with intractable pain caused by sympathetic neuropathy of lower extremities

Primary Outcome Measures

Name	Time	Method
The success rate of block	through study completion, an average of 7 days	Numerical rating score（NRS） less than 4

Secondary Outcome Measures

Name	Time	Method
The skin temperature	10 minutes	The skin temperature
The number of patients satisfied with the first angiography	immediately	The number of patients satisfied with the first angiography
The toe perfusion index	10 minutes	The toe perfusion index

Trial Locations

Locations (1)

The second affiliated hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China