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

Sponsor

Seoul National University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06130514

Collaborator

(none)

118

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain Neuropathic Pain Complex Regional Pain Syndromes Post Herpetic Neuralgia Post Laminectomy Syndrome	Procedure: Stellate Ganglion Block (SGB) Procedure: Thoracic Sympathetic Ganglion Block (TSGB)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 10, 2023

Anticipated Primary Completion Date :

Dec 10, 2025

Anticipated Study Completion Date :

Jan 10, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: Stellate Ganglion Block (SGB) Ultrasound-guided stellate ganglion block
Active Comparator: 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.	Procedure: Thoracic Sympathetic Ganglion Block (TSGB) Fluoroscopic-guided thoracic sympathetic ganglion block

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: Stellate Ganglion Block (SGB)

Ultrasound-guided stellate ganglion block

Active Comparator: 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.

Procedure: Thoracic Sympathetic Ganglion Block (TSGB)

Fluoroscopic-guided thoracic sympathetic ganglion block

Outcome Measures

Primary Outcome Measures

(1) Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand [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]

Secondary Outcome Measures

(1) Difference of temperature change (°C) between ipsilateral hand and contralateral hand [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]
(2) Severity of pain [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 NRS
(3) Patient satisfaction (PGIC scale) [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
(4) Comparison of Korean version CISS(Cold Intolerance Symptom Severity) Questionnaire [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 before block and 20minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block]
cm/s

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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