Clinical trial NCT06130514: The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Sympathetic Ganglion Block
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Neuropathic Pain
Complex Regional Pain Syndromes
Post Herpetic Neuralgia
Post Laminectomy Syndrome
Lead sponsor: Seoul National University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 118
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: (1) Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand
timeFrame: 20 minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
Secondary outcomes:
measure: (1) Difference of temperature change (°C) between ipsilateral hand and contralateral hand
timeFrame: 20 minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
measure: (2) Severity of pain
timeFrame: Time before block and 20 minutes and 1 week and 4weeks after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
measure: (3) Patient satisfaction (PGIC scale)
timeFrame: 20 minutes and 1 week and 4 weeks after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
measure: (4) Comparison of Korean version CISS(Cold Intolerance Symptom Severity) Questionnaire
timeFrame: Time before block and 4 weeks after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
measure: (5) Blood flow velocity measurement in upper extremity vessel(ipsilateral brachial artery) using ultrasound
timeFrame: Time before block and 20minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Jee Youn Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. 2024 Jul 8;49(7):528-535. doi: 10.1136/rapm-2023-104624.
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.
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.
citation: Day M. Sympathetic blocks: the evidence. Pain Pract. 2008 Mar-Apr;8(2):98-109. doi: 10.1111/j.1533-2500.2008.00177.x.
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.