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

Primary Purpose

Complex Regional Pain Syndromes, Postherpetic Neuralgia, Phantom Limb Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
US-SGB
US-TPVB
Sponsored by
Seoul National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndromes

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

US-SGB

US-TPVB

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Comparison of Korean version CISS(Cold Intolerance Symptom Severity) Questionnaire
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
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.

Full Information

First Posted
May 3, 2021
Last Updated
October 16, 2023
Sponsor
Seoul National University
Collaborators
SMG-SNU Boramae Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04876989
Brief Title
The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Paravertebral Block
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
December 19, 2022 (Actual)
Study Completion Date
January 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University
Collaborators
SMG-SNU Boramae Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndromes, Postherpetic Neuralgia, Phantom Limb Pain, Chronic Post Surgical Pain, Post-Traumatic Neuralgia, Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
US-SGB
Arm Type
Active Comparator
Arm 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.
Arm Title
US-TPVB
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
US-SGB
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
US-TPVB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand
Description
Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger.
Time Frame
20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Secondary Outcome Measure Information:
Title
Difference of temperature change (°C) between ipsilateral hand and contralateral hand
Description
Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger.
Time Frame
20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Title
Severity of pain
Description
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 Frame
Time before block and 20 minutes and 1 week and 4weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Title
Patient global impression change (PGIC)
Description
The PGIC will be evaluated 20 minutes, 1 week and 4 weeks after the block using a 5-point Likert scale.
Time Frame
Time 20 minutes and 1 week and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Title
Comparison of Korean version CISS(Cold Intolerance Symptom Severity) Questionnaire
Description
Check the CISS before the procedure and 4 weeks after the procedure.
Time Frame
Time before block and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Title
Blood flow velocity measurement in upper extremity vessel(ipsilateral brachial artery) using ultrasound
Description
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 Frame
Time before block and 20minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youn Moon Jee, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jeongsoo Kim, MD
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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