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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06130514
• Other study ID #: 2309-150-1472
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 10, 2024
• Est. completion date: January 10, 2026

Study information

• Verified date: May 2024
• Source: Seoul National University
• Contact: Jee Youn Moon, MD, PhD
• Phone: 821052992036
• Email: jymoon0901[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: January 10, 2026
• Est. primary completion date: December 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Complex Regional Pain Syndromes
• Ganglion Cysts
• Neuralgia
• Neuralgia, Postherpetic
• Neuropathic Pain
• Post Herpetic Neuralgia
• Reflex Sympathetic Dystrophy
• Syndrome

Intervention

Device:
• Ultrasound
Ultrasound-guided stellate ganglion block with 1% mepivacaine 5 mL
• Fluoroscopy
Fluoroscopic-guided thoracic sympathetic ganglion block with 1% mepivacaine 3 mL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University

References & Publications (6)

Day M. Sympathetic blocks: the evidence. Pain Pract. 2008 Mar-Apr;8(2):98-109. doi: 10.1111/j.1533-2500.2008.00177.x. Erratum In: Pain Pract. 2008 Jul-Aug;18(4):335-6. — View Citation

Kim J, Lee HJ, Lee YJ, Lee CS, Yoo Y, Moon JY. Ultrasound-Guided Thoracic Paravertebral Block as a Sympathetic Blockade for Upper Extremity Neuropathic Pain: A Prospective Pilot Study. J Pain Res. 2020 Dec 14;13:3395-3403. doi: 10.2147/JPR.S285998. eCollection 2020. — View Citation

Kim J, Yun M, Han AH, Pauzi MF, Jeong JH, Yoo Y, Moon JY. Thoracic sympathetic ganglion blocks: real-world outcomes in 207 chronic pain patients. Reg Anesth Pain Med. 2023 Sep 19:rapm-2023-104624. doi: 10.1136/rapm-2023-104624. Online ahead of print. — View Citation

Kim YH, Kim SY, Lee YJ, Kim ED. A Prospective, Randomized Cross-Over Trial of T2 Paravertebral Block as a Sympathetic Block in Complex Regional Pain Syndrome. Pain Physician. 2019 Sep;22(5):E417-E424. — View Citation

Rocha Rde O, Teixeira MJ, Yeng LT, Cantara MG, Faria VG, Liggieri V, Loduca A, Muller BM, Souza AC, de Andrade DC. Thoracic sympathetic block for the treatment of complex regional pain syndrome type I: a double-blind randomized controlled study. Pain. 2014 Nov;155(11):2274-81. doi: 10.1016/j.pain.2014.08.015. Epub 2014 Aug 19. — View Citation

Yoo HS, Nahm FS, Lee PB, Lee CJ. Early thoracic sympathetic block improves the treatment effect for upper extremity neuropathic pain. Anesth Analg. 2011 Sep;113(3):605-9. doi: 10.1213/ANE.0b013e3182274803. Epub 2011 Jul 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(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	(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
Secondary	(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
Secondary	(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
Secondary	(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
Secondary	(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