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

Primary Purpose

Pain, Chronic, Sympathetic Disorder, Ultrasound Therapy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ultrasound and CT
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic focused on measuring lumbar sympathetic, ultrasound

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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:

  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.

Sites / Locations

  • The second affiliated hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ultrasound combined with CT guided

CT guided

Arm Description

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

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

Outcomes

Primary Outcome Measures

The success rate of block
Numerical rating score（NRS） less than 4

Secondary Outcome Measures

The skin temperature
The skin temperature
The toe perfusion index
The toe perfusion index
The number of patients satisfied with the first angiography
The number of patients satisfied with the first angiography

Full Information

First Posted
October 17, 2019
Last Updated
October 26, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
China-Japan Friendship Hospital, First People's Hospital of Hangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT04167956
Brief Title
Clinical Trial of Ultrasound Combined With Computed Tomography Guided Lumbar Sympathetic Ganglion Block
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
China-Japan Friendship Hospital, First People's Hospital of Hangzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Sympathetic Disorder, Ultrasound Therapy
Keywords
lumbar sympathetic, ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
246 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ultrasound combined with CT guided
Arm Type
Experimental
Arm Description
ultrasound combined with CT guided lumbar sympathetic ganglion block in patients with intractable pain caused by sympathetic neuropathy of lower extremities
Arm Title
CT guided
Arm Type
Sham Comparator
Arm Description
CT guided lumbar sympathetic ganglion block in patients with intractable pain caused by sympathetic neuropathy of lower extremities
Intervention Type
Device
Intervention Name(s)
ultrasound and CT
Intervention Description
Experimental: ultrasound combined with CT guided Active Comparator: CT guided
Primary Outcome Measure Information:
Title
The success rate of block
Description
Numerical rating score（NRS） less than 4
Time Frame
through study completion, an average of 7 days
Secondary Outcome Measure Information:
Title
The skin temperature
Description
The skin temperature
Time Frame
10 minutes
Title
The toe perfusion index
Description
The toe perfusion index
Time Frame
10 minutes
Title
The number of patients satisfied with the first angiography
Description
The number of patients satisfied with the first angiography
Time Frame
immediately

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Yan, Doctor
Phone
13757118632
Email
zryanmin@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Yan, Doctor
Organizational Affiliation
Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
The second affiliated hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Yan, Doctor
Phone
13757118632
Ext
13252017900
Email
zryanmin@zju.edu.cn

12. IPD Sharing Statement

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

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