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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04167956

Enrollment

246

Registered

2019-11-19

Start date

2020-10-15

Completion date

2022-01-31

Last updated

2020-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Chronic, Sympathetic Disorder, Ultrasound Therapy

Keywords

lumbar sympathetic, ultrasound

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.

Interventions

DEVICEultrasound and CT

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
The success rate of block	through study completion, an average of 7 days	Numerical rating score（NRS） less than 4

Secondary

Measure	Time frame	Description
The skin temperature	10 minutes	The skin temperature
The toe perfusion index	10 minutes	The toe perfusion index
The number of patients satisfied with the first angiography	immediately	The number of patients satisfied with the first angiography

Countries

China

Contacts

Primary ContactMin Yan, Doctor

zryanmin@zju.edu.cn13757118632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026