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

NCT ID: NCT04167956

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Pain, Chronic Sympathetic Disorder Ultrasound Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

ultrasound and CT

Intervention Type DEVICE

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

CT guided

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

Group Type SHAM_COMPARATOR

ultrasound and CT

Intervention Type DEVICE

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

Interventions

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ultrasound and CT

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Yan, Doctor

Role: STUDY_CHAIR

Zhejiang University

Locations

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The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Yan, Doctor

Role: CONTACT

[email protected]
13757118632

Facility Contacts

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Min Yan, Doctor

Role: primary

[email protected]
13757118632 ext. 13252017900

Other Identifiers

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ym20191016

Identifier Type: -

Identifier Source: org_study_id