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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Procedure: US-SGB
* Procedure: US-TPVB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: US-SGB<br>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<br>* 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.<br>|
| Active Comparator: US-TPVB<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 
| 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 | 
| 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 |