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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Chronic Pain, Neuropathic Pain, Complex Regional Pain Syndromes, Post Herpetic Neuralgia, Post Laminectomy Syndrome

Intervention / Treatment
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* Device: Ultrasound
* Device: Fluoroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound-guided stellate ganglion block (US-guided SGB)<br>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<br>* Ultrasound-guided stellate ganglion block with 1% mepivacaine 5 mL<br>|
| Active Comparator: Fluoroscopy-guided thoracic sympathetic ganglion block (FS-guided TSGB)<br>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<br>* Fluoroscopic-guided thoracic sympathetic ganglion block with 1% mepivacaine 3 mL<br>|

What is the study measuring?
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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 | [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 | [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 | 
| (2) Severity of pain | 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 | 
| (3) Patient satisfaction (PGIC scale) | 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 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 | cm/s | Time before block and 20minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block |