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

Not Applicable

Recruiting

• Conditions: Pain, Chronic
• Interventions: Procedure: Erector spinae plane block; Procedure: cervical epidural injection

• Registration Number: NCT05487326
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-04
• Study Start: 2022-08-07
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-02
• Last Update Posted: 2023-04-05
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high thoracic ESPB group	Erector spinae plane block	Group where ESPB is performed at T2 with local anesthetic mixture 20 ml
cervical epidural group	cervical epidural injection	Group where cervical epidural injection is performed at C6-7 or C7-T1 level

Primary Outcome Measures

Name	Time	Method
Changes of numerical rating scale	baseline, 10 min after injection, 1wk after injection, 2 wks after injection, 4 wks after injection, 8 wks after injection	Changes of 11-point numerical rating scale (0-10)

Secondary Outcome Measures

Name	Time	Method
Changes of neck disability index	baseline, 8 wks after injection	Changes of back pain funtional scale

Trial Locations

Locations (1)

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