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

NCT04167956 | Unknown

• 1 other identifier: ym20191016
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic; Sympathetic Disorder; Ultrasound Therapy

Keywords

lumbar sympathetic; ultrasound

Outcome Measures

Primary Outcomes (1)

• The success rate of block

  Numerical rating score（NRS） less than 4

  through study completion, an average of 7 days

Secondary Outcomes (3)

• The skin temperature

  10 minutes

• The toe perfusion index

  10 minutes

• The number of patients satisfied with the first angiography

  immediately

Study Arms (2)

ultrasound combined with CT guided

EXPERIMENTAL

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

CT guided

SHAM COMPARATOR

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

Device: ultrasound and CT

Interventions

ultrasound and CT DEVICE

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

CT guided; ultrasound combined with CT guided

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Autonomic Nervous System Diseases

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Min Yan, Doctor

  Zhejiang University

  STUDY CHAIR

Central Study Contacts

Min Yan, Doctor

CONTACT

13757118632; zryanmin@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: November 19, 2019
• Study Start: October 15, 2020
• Primary Completion: October 31, 2021
• Study Completion: January 31, 2022
• Last Updated: October 28, 2020

Record last verified: 2020-01

Locations

CN (1)