The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Sympathetic Ganglion Block

May 27, 2024 updated by: Jeeyoun Moon, Seoul National University

The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Sympathetic Ganglion Block in Patients With Chronic Upper Extremity Neuropathic Pain: a Prospective Randomized and Comparative Clinical Trial

For patients scheduled to undergo upper limb sympathetic nerve block due to chronic neuropathic pain in the upper limb lasting more than 3 months, the ultrasound-guided stellate ganglion block group (S group) and the fluoroscopy-guided thoracic sympathetic nerve block group (T) Patients are randomly assigned 1:1 to one of the groups, and the procedure is performed. To evaluate the effectiveness of sympathetic nerve blockade, temperature changes in both palms are measured twice, 20 minutes before and 20 minutes after the procedure, using an infrared thermographer. Other variables related to the procedure are surveyed by outpatient visit or telephone before the procedure, after the procedure, before returning home, and 1 week and 1 month after the procedure.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients aged 19 to 85 with upper limb pain are directly informed about the study, recruited, and enrolled at the Seoul National University Hospital Pain Center.

Before and after the procedure, continuous monitoring of electrocardiography, blood pressure, pulse rate, and oxygen saturation is carried out.

Before undergoing thoracic sympathetic ganglion block (TSGB) guided by fluoroscopy or ultrasound-guided stellate ganglion block (SGB), the temperature of both palms is measured using an infrared thermometer. Prior to the procedure, Doppler mode ultrasound equipment is used to measure blood flow velocity in the upper limb arteries (brachial artery).

In the case of ultrasound-guided stellate ganglion block, the patient is placed in a supine position, and the procedure is performed using ultrasound guidance to inject 5 mL of 1% mepivacaine at the level of C6. For fluoroscopy-guided thoracic sympathetic ganglion block, the patient is positioned prone, and 3 mL of 1% mepivacaine is injected at the level of T3. In both cases, the procedure is performed by a specialist with a rank of professor or higher who specializes in pain management.

After the procedure, the palm temperature is measured again 20 minutes later using an infrared thermometer.

Blood flow velocity in the upper limb arteries (brachial artery) is also measured 20 minutes post-procedure using Doppler mode ultrasound equipment.

Additionally, various procedure-related variables are assessed through outpatient visits or telephone surveys conducted before the procedure, at discharge, one week post-procedure, and four weeks post-procedure.

Study Type

Interventional

Enrollment (Estimated)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients with 19 - 85 years
  • Patients with chronic upper extremity pain that lasts for more than 3 months
  • Neuropathic pain conditions such as postherpetic neuralgia, complex regional pain syndrome, post laminectomy syndrome of cervical spine
  • Patients judged to require sympathetic blockade by pain physician

Exclusion Criteria:

  • Patient refusal
  • Presence of upper limb vascular disorders
  • History of previous thoracic sympathetic ganglion removal or neurolysis
  • Abnormal findings in blood coagulation tests
  • Systemic infection or local injection site infection
  • Anatomical deformities at the injection site
  • Allergic reactions to the injected medications
  • Higher baseline hand temperature on the procedure side than the tympanic temperature (36.5°C) on pre-procedure thermography
  • Other cases deemed inappropriate by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound-guided stellate ganglion block (US-guided SGB)
In the case of ultrasound-guided stellate ganglion block, the patient is made to lie down and stellate ganglion block is performed by injecting 5 mL of 1% mepivacaine at the level of the 6th cervical vertebra using ultrasound.
Device: Ultrasound
Ultrasound-guided stellate ganglion block with 1% mepivacaine 5 mL
Active Comparator: Fluoroscopy-guided thoracic sympathetic ganglion block (FS-guided TSGB)
In the case of fluoroscopic device-guided thoracic sympathetic nerve block, place the patient prone and inject 3 mL of 1% mepivacaine at the level of the third thoracic vertebra to perform thoracic sympathetic nerve block.
Device: Fluoroscopy
Fluoroscopic-guided thoracic sympathetic ganglion block with 1% mepivacaine 3 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(1) Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand
Time Frame: 20 minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
[ipsilateral hand temperature after the block - ipsilateral hand temperature before the block] - [contralateral hand temperature after the block - contralateral hand temperature before the block]
20 minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(1) Difference of temperature change (°C) between ipsilateral hand and contralateral hand
Time Frame: 20 minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
[ipsilateral hand temperature after the block - ipsilateral hand temperature before the block] - [contralateral hand temperature after the block - contralateral hand temperature before the block]
20 minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
(3) Patient satisfaction (PGIC scale)
Time Frame: 20 minutes and 1 week and 4 weeks after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
5-point Likert Scale
20 minutes and 1 week and 4 weeks after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
(4) Comparison of Korean version CISS(Cold Intolerance Symptom Severity) Questionnaire
Time Frame: Time before block and 4 weeks after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
Time before block and 4 weeks after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
(5) Blood flow velocity measurement in upper extremity vessel(ipsilateral brachial artery) using ultrasound
Time Frame: Time before block and 20minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
cm/s
Time before block and 20minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
(2) Severity of pain
Time Frame: Time before block and 20 minutes and 1 week and 4weeks after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
11-point numerical rating scale (NRS)
Time before block and 20 minutes and 1 week and 4weeks after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University

Investigators

  • Principal Investigator: Jee Youn Moon, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 10, 2024

Primary Completion (Estimated)

December 10, 2025

Study Completion (Estimated)

January 10, 2026

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 27, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2309-150-1472

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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