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Status unknownNCT04167956Updated Oct 28, 2020

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

An interventional study of ultrasound and CT in Pain, Chronic, Sympathetic Disorder and Ultrasound Therapy, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-28.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
246
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain, Chronic
  • Sympathetic Disorder
  • Ultrasound Therapy

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Keywords

  • lumbar sympathetic
  • ultrasound
03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's planned enrollment of 246 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
246 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Deviceultrasound and CT

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

06

What researchers measure

Primary outcomes

  1. The success rate of block

    Numerical rating score(NRS) less than 4

    Time frame: through study completion, an average of 7 days

Secondary outcomes

  1. The skin temperature

    The skin temperature

    Time frame: 10 minutes

  2. The toe perfusion index

    The toe perfusion index

    Time frame: 10 minutes

  3. The number of patients satisfied with the first angiography

    The number of patients satisfied with the first angiography

    Time frame: immediately

07

Study locations

1 of 1 sites recruiting
  • The second affiliated hospital of Zhejiang University
    Hangzhou, Zhejiang 310000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04167956
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
China-Japan Friendship Hospital, First People's Hospital of Hangzhou
Responsible party
Sponsor
First posted
Nov 19, 2019
Start date
Oct 15, 2020
Primary completion
Oct 31, 2021 (estimated)
Completion
Jan 31, 2022 (estimated)
Last update
Oct 28, 2020

Study contacts

Min Yan, Doctor
Contact
zryanmin@zju.edu.cn
13757118632
Min Yan, Doctor
study chair · Zhejiang University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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