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

Trial Title: The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Sympathetic Ganglion Block

NCT ID: NCT06130514

Condition: Chronic Pain
Neuropathic Pain
Complex Regional Pain Syndromes
Post Herpetic Neuralgia
Post Laminectomy Syndrome

Conditions: Official terms:
Ganglion Cysts
Neuralgia
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Neuralgia, Postherpetic
Syndrome
Chronic Pain

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Device
Intervention name: Ultrasound
Description: Ultrasound-guided stellate ganglion block with 1% mepivacaine 5 mL
Arm group label: Ultrasound-guided stellate ganglion block (US-guided SGB)

Intervention type: Device
Intervention name: Fluoroscopy
Description: Fluoroscopic-guided thoracic sympathetic ganglion block with 1% mepivacaine 3 mL
Arm group label: Fluoroscopy-guided thoracic sympathetic ganglion block (FS-guided TSGB)

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.

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 19 Years

Maximum age: 85 Years

Healthy volunteers: No

Start date: July 10, 2024

Completion date: January 10, 2026

Lead sponsor:
Agency: Seoul National University
Agency class: Other

Source: Seoul National University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06130514