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

Seoul National University

Status: Completed

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

Treatments: Procedure: US-SGB; Procedure: US-TPVB

Study type: Interventional

Funder types: Other

Identifiers

NCT04876989

2102-183-120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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69 participants in 2 patient groups

US-SGB

Active Comparator group

Description:

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

Treatment:

Procedure: US-SGB

US-TPVB

Active Comparator group

Description:

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

Treatment:

Procedure: US-TPVB