Pain Relief After High Thoracic Eretor Spinae Block

Not Applicable

Completed

• Conditions: Pain, Chronic
• Interventions: Procedure: Erector spinae plane block

• Registration Number: NCT05487313
• Lead Sponsor: Keimyung University Dongsan Medical Center

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.

Study Timeline

• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-04
• Study Start: 2022-08-12
• Status Verified: 2023-03
• Primary Completion: 2023-03-21
• Study Completion: 2023-03-21
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 ml ESP group	Erector spinae plane block	ESP group using 10 ml mixture of local anesthetics and contrast medium
20 ml ESP group	Erector spinae plane block	ESP group using 20 ml mixture of local anesthetics and contrast medium

Primary Outcome Measures

Name	Time	Method
Neck disability scale changes	baseline, 8 weeks after ESPB	Neck disability scale changes after T2 ESPB among 2 times period
numerical rating scale changes among 5 times period	baseline, 10 minutes after ESPB, 1 week after ESPB, 2 weeks after ESPB, 4 weeks after ESPB, 8 weeks after ESPB	numerical rating scale changes after T2 ESPB among 5 times period

Secondary Outcome Measures

Name	Time	Method
spread level in the cranio-caudal direction	baseline, 1 minute after erector spinae plane block	fluoroscopic contrast medium spread level in the cranio-caudal direction

Trial Locations

Locations (1)

Hong ji HEE; 🇰🇷 Daegu, Korea, Republic of