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

Pain, Chronic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04167956
• Other study ID #: ym20191016
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: January 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Yan, Doctor
• Phone: 13757118632
• Email: zryanmin[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: January 31, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic
• Sympathetic Disorder
• Ultrasound Therapy

Intervention

Device:
• ultrasound and CT
Experimental: ultrasound combined with CT guided Active Comparator: CT guided

Locations

Country	Name	City	State
China	The second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	China-Japan Friendship Hospital, First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of block	Numerical rating score(NRS) less than 4	through study completion, an average of 7 days
Secondary	The skin temperature	The skin temperature	10 minutes
Secondary	The toe perfusion index	The toe perfusion index	10 minutes
Secondary	The number of patients satisfied with the first angiography	The number of patients satisfied with the first angiography	immediately