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

Sponsor

Seoul National University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04876989

Collaborator

SMG-SNU Boramae Medical Center (Other)

Enrollment

Location

Arms

11.3

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complex Regional Pain Syndromes Postherpetic Neuralgia Phantom Limb Pain Chronic Post Surgical Pain Post-Traumatic Neuralgia Neuropathic Pain	Procedure: US-SGB Procedure: US-TPVB	N/A

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. 6ml 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. 10ml 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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 21, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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 satisfaction [Time before block and 20 minutes and 1 week and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block]
The patient satisfaction will be evaluated before the block and 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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 > 35°C in the thermography before the procedure