Comparison of Pain Relief Between High Thoracic Erector Spinae Plane Block and Cervical Epidural Injection

NCT ID: NCT05487326

Last Updated: 2023-04-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-07

Study Completion Date

2023-04-30

Brief Summary

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The primary endpoint of this study was to identify whether there is a pain improving effect of high thoracic eretor spinae plane block (ESPB) when compared with cervical epidural injection

Detailed Description

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The erector spinae plane block (ESPB) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. In contrast to common neuraxial techniques such as paravertebral and epidural injections, the ESPB targets an interfascial plane which is far from the spinal cord, root, and pleura. First applied to thoracic neuropathic pain, currently ESPB is being applied to postoperative pain control and includes variable clinical situations. In the abdomen and thoracic wall, thoracic ESPB can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. Recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar ESPB. In addition, ESPB has also been used for chronic pain conditions in the upper and lower extremities. To investigate the possible mechanism of action of the ESPB, many previous studies have focused on examining the physical spread of the injected agent. Commonly, contrast dye injections in human cadavers have been utilized to assess the spread level. Physical spread level was determined using various methods including direct dissection or sectioning, computed tomography (CT), thoracoscopic inspection, or magnetic resonance imaging (MRI) with radiocontrast injection. Apart from human cadaver studies, physical spread level has been evaluated in alive patients using a variable volume of local anesthetics mixed with radiocontrast. However, these studies are limited by the small number of included patients.

Conditions

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Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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high thoracic ESPB group

Group where ESPB is performed at T2 with local anesthetic mixture 20 ml

Group Type ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type PROCEDURE

fascial plane injection guided by ultrasound guidance

cervical epidural group

Group where cervical epidural injection is performed at C6-7 or C7-T1 level

Group Type ACTIVE_COMPARATOR

cervical epidural injection

Intervention Type PROCEDURE

cervical epidural injection by fluoroscopy

Interventions

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Erector spinae plane block

fascial plane injection guided by ultrasound guidance

Intervention Type PROCEDURE

cervical epidural injection

cervical epidural injection by fluoroscopy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* cervical spinal stenosis
* cervical intervertebral disc herniation
* cervical facet arthropathy
* cervical foraminal stenosis

Exclusion Criteria

* Allergy to local anesthetics or contrast medium
* Pregnancy
* Spine deformity
* Patients with coagulation abnormality
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ji Hee Hong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ji H Hong, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Keimyung University

Locations

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Hong ji HEE

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ji H Hong, Ph.D

Role: CONTACT

01046794343

Sung W Jung

Role: CONTACT

01021064343

Facility Contacts

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J Hee Hong

Role: primary

82-53-258-7767

Other Identifiers

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2022-01-026-03

Identifier Type: -

Identifier Source: org_study_id

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