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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04167956

Collaborator

China-Japan Friendship Hospital (Other), First People's Hospital of Hangzhou (Other)

246

Enrollment

Location

Arms

15.5

Anticipated Duration (Months)

15.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Chronic Sympathetic Disorder Ultrasound Therapy	Device: ultrasound and CT	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

246 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 15, 2020

Anticipated Primary Completion Date :

Oct 31, 2021

Anticipated Study Completion Date :

Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ultrasound combined with CT guided 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 Experimental: ultrasound combined with CT guided Active Comparator: CT guided
Sham Comparator: CT guided CT guided lumbar sympathetic ganglion block in patients with intractable pain caused by sympathetic neuropathy of lower extremities	Device: ultrasound and CT Experimental: ultrasound combined with CT guided Active Comparator: CT guided

Arm

Intervention/Treatment

Experimental: ultrasound combined with CT guided

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

Experimental: ultrasound combined with CT guided Active Comparator: CT guided

Sham Comparator: CT guided

CT guided lumbar sympathetic ganglion block in patients with intractable pain caused by sympathetic neuropathy of lower extremities

Device: ultrasound and CT

Experimental: ultrasound combined with CT guided Active Comparator: CT guided

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

The skin temperature [10 minutes]
The skin temperature
The toe perfusion index [10 minutes]
The toe perfusion index
The number of patients satisfied with the first angiography [immediately]
The number of patients satisfied with the first angiography

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

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

Investigators

Study Chair: Min Yan, Doctor, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT04167956

Other Study ID Numbers:

ym20191016

First Posted:

Nov 19, 2019

Last Update Posted:

Oct 28, 2020

Last Verified:

Jan 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University

lumbar sympathetic

ultrasound

Additional relevant MeSH terms:

Chronic Pain

Study Results

No Results Posted as of Oct 28, 2020