Pain Relief After High Thoracic Eretor Spinae Block

NCT ID: NCT05487313

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-12
• Study Completion Date: 2023-03-21

Brief Summary

The primary endpoint of this study was to identify if the ESPB in the patients of cervical radiculopathy has the effect of pain relief. The secondary endpoint of this study was to identify the spread level in the craniocaudal direction when performed at the T2 level.

Detailed Description

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 (1,10). 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

Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

10 ml ESP group

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

Group Type: ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type: PROCEDURE

fascial plane injection guided by fluoroscopic device after ultrasound guidance

20 ml ESP group

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

Group Type: ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type: PROCEDURE

fascial plane injection guided by fluoroscopic device after ultrasound guidance

Interventions

Erector spinae plane block

fascial plane injection guided by fluoroscopic device after ultrasound guidance

Intervention Type: PROCEDURE

Eligibility Criteria

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

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ji Hee Hong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ji H Hong, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Keimyung University

Locations

Hong ji HEE

Daegu, , South Korea

Countries

South Korea

Other Identifiers

2022-01-026-02

Identifier Type: -

Identifier Source: org_study_id