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

NCT04876989 | Completed

• 1 other identifier: 2102-183-120
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of ultrasound-guided thoracic paravertebral block (TPVB) when performing sympathetic block for upper limb pain control.

Conditions

Complex Regional Pain Syndromes; Postherpetic Neuralgia; Phantom Limb Pain; Chronic Post Surgical Pain; Post-Traumatic Neuralgia; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand

  Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger.

  20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block

Secondary Outcomes (5)

• Difference of temperature change (°C) between ipsilateral hand and contralateral hand

  20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block

• Severity of pain

  Time before block and 20 minutes and 1 week and 4weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block

• Patient global impression change (PGIC)

  Time 20 minutes and 1 week and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block

• Comparison of Korean version CISS(Cold Intolerance Symptom Severity) Questionnaire

  Time before block and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block

• Blood flow velocity measurement in upper extremity vessel(ipsilateral brachial artery) using ultrasound

  Time before block and 20minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block

Study Arms (2)

US-SGB

ACTIVE COMPARATOR

5 ml of 1% mepivacaine is injected for stellate ganglion block using the Ultrasound(US)-guided lateral approach at the sixth cervical vertebral level.

Procedure: US-SGB

US-TPVB

ACTIVE COMPARATOR

10 ml of 1% mepivacaine is injected for thoracic paravertebral block using the Ultrasound(US)-guided sagittal approach at the second thoracic paravertebral space.

Procedure: US-TPVB

Interventions

US-SGB PROCEDURE

Well trained pain physician performs all the ultrasound(US)-guided stellate ganglion block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 5 ml of 1% mepivacaine is injected for the US-SGB group.

US-SGB

US-TPVB PROCEDURE

Well trained pain physician performs all the ultrasound(US)-guided thoracic paravertebral block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For US-guided TPVB, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at T2 paravertebral space. 10 ml of 1% mepivacaine is injected for the US-TPVB group.

US-TPVB

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of complex regional pain syndrome
• Clinical diagnosis of postherpetic neuralgia
• Clinical diagnosis of phantom limb pain
• Clinical diagnosis of chronic post-surgical pain
• Clinical diagnosis of post-traumatic pain syndrome
• Upper extremity pain lasting more than 3 months
• Patients with a new or known diagnosis of chronic neuropathic pain lasting more than 3 months in the upper extremity

You may not qualify if:

• Refusal of a patient
• Any vascular disease in the upper extremities
• Previous history of thoracic sympathetic or stellate ganglion neurolysis (e.g. -thermocoagulation, radiofrequency neuromodulation, and/or chemical neurolysis)
• Coagulopathy
• Systemic infection or local infection at the needle injection site
• Major deformation at the level of the neck (radiotherapy, surgery, etc.)
• Known allergy to local anesthetics of amide type
• Inability to understand a numeric rating pain scale (cognitive dysfunction)
• Patients whose palm temperature on the ipsilateral side is ≥ 36.5℃ in the thermography before the procedure

Sponsors & Collaborators

• Seoul National University: lead
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Neuralgia, Postherpetic; Phantom Limb; Pain, Postoperative; Neuralgia

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Postoperative Complications; Pathologic Processes

Study Officials

• Youn Moon Jee, MD, PhD

  Seoul National University Hospital

  STUDY DIRECTOR

• Jeongsoo Kim, MD

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 7, 2021
• Study Start: July 21, 2021
• Primary Completion: December 19, 2022
• Study Completion: January 16, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)