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

NCT06130514 | Not Yet Recruiting

• 1 other identifier: 2309-150-1472
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Pain; Neuropathic Pain; Complex Regional Pain Syndromes; Post Herpetic Neuralgia; Post Laminectomy Syndrome

Outcome Measures

Primary Outcomes (1)

• (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 Outcomes (5)

• (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

• (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

• (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

• (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

Study Arms (2)

Ultrasound-guided stellate ganglion block (US-guided SGB)

ACTIVE COMPARATOR

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

Fluoroscopy-guided thoracic sympathetic ganglion block (FS-guided TSGB)

ACTIVE COMPARATOR

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

Interventions

Ultrasound DEVICE

Ultrasound-guided stellate ganglion block with 1% mepivacaine 5 mL

Ultrasound-guided stellate ganglion block (US-guided SGB)

Fluoroscopy DEVICE

Fluoroscopic-guided thoracic sympathetic ganglion block with 1% mepivacaine 3 mL

Fluoroscopy-guided thoracic sympathetic ganglion block (FS-guided TSGB)

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University: lead

Related Publications (6)

• 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.

  PMID: 31561653 BACKGROUND

• 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. 2024 Jul 8;49(7):528-535. doi: 10.1136/rapm-2023-104624.

  PMID: 37726196 BACKGROUND

• 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.

  PMID: 33363406 BACKGROUND

• 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.

  PMID: 21778335 BACKGROUND

• Day M. Sympathetic blocks: the evidence. Pain Pract. 2008 Mar-Apr;8(2):98-109. doi: 10.1111/j.1533-2500.2008.00177.x.

  PMID: 18366465 BACKGROUND

• 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.

  PMID: 25149143 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Neuralgia; Complex Regional Pain Syndromes; Neuralgia, Postherpetic; post laminectomy syndrome

Interventions

Ultrasonography; Fluoroscopy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography

Study Officials

• Jee Youn Moon, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jee Youn Moon, MD, PhD

CONTACT

821052992036; jymoon0901@gmail.com

Jeongsoo Kim, MD

CONTACT

821047346422; dreamsu4@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 14, 2023
• Study Start: July 10, 2024
• Primary Completion: December 10, 2025
• Study Completion: January 10, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-05