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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Chronic; Ultrasound Therapy; Sympathetic Disorder
• Intervention / Treatment: Device: ultrasound and CT

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 Type: Interventional
• Enrollment (Anticipated): 246
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: First People's Hospital of Hangzhou; China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2020
• Primary Completion (ANTICIPATED): October 31, 2021
• Study Completion (ANTICIPATED): January 31, 2022

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (ACTUAL): November 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: ultrasound; lumbar sympathetic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: ym20191016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No