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Analysis of Injectate Spread During Erector Spinae Block

NCT ID: NCT05280847

Last Updated: 2022-12-20

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

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-21

Study Completion Date

2022-10-30

Brief Summary

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The primary purpose of this study was to identify the ESPB spread level in the craniocaudal direction when performed at the T2 level. The secondary purpose was to determine the incidence of spread into epidural, paravertebral, intercostal, and intravascular injections with ESPB

Detailed Description

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The ESPB requires ultrasound guidance which enables visible local anesthetic spread underneath the erector spinae muscles. The spinalis, longissimus thoracis, and iliocostalis muscles comprise the ES muscles, which run vertically along both sides of the vertebral column from the sacrum up to the skull base. The ESPB can be performed in the cervical, thoracic, and lumbar regions. Among them, upper or mid thoracic ESPB has been used more widely compared to cervical and lumbar regions. Previous cadaveric studies on the ESPB at the T5 level using computed tomography (CT) reconstruction or direct dissection demonstrated the extensive craniocaudal distribution of methylene blue ranging from T1 to T8 vertebral segments deep to the ES muscles and variable involvement of epidural, paravertebral, and intercostal spaces. The ESPB performed at the T2 level of the cadaver demonstrated an injected dye distribution ranging from C4 to T10. Also, 36% of cadavers showed the spread of an injected dye to the ventral, dorsal ramus, paravertebral space, and even the contralateral side. The exact mechanism of action of ESPB remains unclear. A recent study suggested that the analgesic effect of ESPB could be obtained by blocking the ventral and dorsal ramus of the spinal nerves by passing through the costotransverse foramen. However, in clinical practice, we can encounter highly variable clinical outcomes or sensory block after the ESPB. The study of the physical spread of the injected agent can be used to predict the clinical result and elucidate the possible mechanism of action of ESPB.

Conditions

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Pain Cervical

Keywords

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Pain Cervical Spread

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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10 ml ESP group

ESP group using 10 ml mixture of local anesthetics and contrast medium using ultrasound and fluoroscopy

Group Type EXPERIMENTAL

Erector spinae plane block

Intervention Type PROCEDURE

fascial plane injection using ultrasound and fluoroscopic guidance

20 ml ESP group

ESP group using 20 ml mixture of local anesthetics and contrast medium using ultrasound and fluoroscopy

Group Type EXPERIMENTAL

Erector spinae plane block

Intervention Type PROCEDURE

fascial plane injection using ultrasound and fluoroscopic guidance

Interventions

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Erector spinae plane block

fascial plane injection using ultrasound and fluoroscopic guidance

Intervention Type PROCEDURE

Other Intervention Names

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ESP

Eligibility Criteria

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Inclusion Criteria

* Cervical facet joint arthrosis
* Cervical foraminal stenosis
* Cervical herniated intervertebral disc
* myofascial pain syndrome of upper back muscle

Exclusion Criteria

* Allergy to local anesthetics or contrast medium
* Pregnancy
* Prior history of cervical spine surgery
* 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

Role: PRINCIPAL_INVESTIGATOR

Keimyung University

Locations

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Hong ji HEE

Daegu, , South Korea

Site Status

Ji Hee Hong

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Keimyung University

Identifier Type: -

Identifier Source: org_study_id