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

NCT ID: NCT04876989

Last Updated: 2023-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-21

Study Completion Date

2023-01-16

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

US-SGB

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

US-TPVB

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SMG-SNU Boramae Medical Center

OTHER

Sponsor Role collaborator

Seoul National University

OTHER

Sponsor Role lead

Responsible Party

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Jeeyoun Moon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Youn Moon Jee, MD, PhD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Jeongsoo Kim, MD

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2102-183-120

Identifier Type: -

Identifier Source: org_study_id

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