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

The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Paravertebral Block in Patients With Chronic Upper Extremity Neuropathic Pain: a Prospective Randomized and Comparative Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Complex Regional Pain Syndromes; Neuropathic Pain; Phantom Limb Pain; Postherpetic Neuralgia; Post-Traumatic Neuralgia; Chronic Post Surgical Pain
• Intervention / Treatment: Procedure: US-SGB; Procedure: US-TPVB

Detailed Description

Well-trained pain physicians performs all US-guided stellate ganglion block(SGB)s or US-guided thoracic paravertebrl block(TPVB)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 SGB group. Syringes are prepared by one nurse who do not involved in other steps of this study.

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 TPVB group. Syringes are prepared by one nurse who do not involved in other steps of this study.

Temperature measurement is conducted 2 times (before US-guided SGB or TPVB and after 20 minutes) at both hands by one person who's not involved in other measuring in the study.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: US-SGB; 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; 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.
Active Comparator: US-TPVB; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of temperature change (°C) between ipsilateral hand and 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
Severity of pain	The severity of the pain will be evaluated before the block and 20 minutes, 1 week and 4 weeks after the block using an 11-pointed NRS (numerical rating scale) pain score.	Time before block and 20 minutes and 1 week and 4weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Comparison of Korean version CISS(Cold Intolerance Symptom Severity) Questionnaire	Check the CISS before the procedure and 4 weeks after the procedure.	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	The blood flow velocity in the ipsilateral brachial artery will be measured before the block and 20 minutes after the block using a Doppler mode ultrasound device.	Time before block and 20minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Patient global impression change (PGIC)	The PGIC will be evaluated 20 minutes, 1 week and 4 weeks after the block using a 5-point Likert scale.	Time 20 minutes and 1 week and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block

Collaborators and Investigators

• Sponsor: Seoul National University
• Collaborators: SMG-SNU Boramae Medical Center
• Investigators: Study Director: Youn Moon Jee, MD, PhD, Seoul National University Hospital; Principal Investigator: Jeongsoo Kim, MD, SMG-SNU Boramae Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): January 16, 2023

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Perceptual Disorders; Pain, Postoperative; Neuralgia; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Phantom Limb; Neuralgia, Postherpetic
• Other Study ID Numbers: 2102-183-120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No