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

Not Applicable

Completed

• Conditions: Chronic Post Surgical Pain; Post-Traumatic Neuralgia; Complex Regional Pain Syndromes; Phantom Limb Pain; Postherpetic Neuralgia; Neuropathic Pain
• Interventions: Procedure: US-TPVB; Procedure: US-SGB

• Registration Number: NCT04876989
• Lead Sponsor: Seoul National University

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.

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 Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-07
• Study Start: 2021-07-21
• Primary Completion: 2022-12-19
• Study Completion: 2023-01-16
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
US-TPVB	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.
US-SGB	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand	20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block	Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger.

Secondary Outcome Measures

Name	Time	Method
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	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.
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	Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger.
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	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.
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	The PGIC will be evaluated 20 minutes, 1 week and 4 weeks after the block using a 5-point Likert scale.
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	Check the CISS before the procedure and 4 weeks after the procedure.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of