Clinical trial NCT05487326: Comparison of Pain Relief Between High Thoracic Erector Spinae Plane Block and Cervical Epidural Injection
Official title: Comparison of Pain Relief Between High Thoracic Erector Spinae Plane Block and Cervical Epidural Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Chronic
Keywords: Pain, lumbar
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of numerical rating scale
timeFrame: baseline, 10 min after injection, 1wk after injection, 2 wks after injection, 4 wks after injection, 8 wks after injection
Secondary outcomes:
measure: Changes of neck disability index
timeFrame: baseline, 8 wks after injection
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Hong ji HEE
Study officials:
affiliation: Keimyung University
name: Ji H Hong, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: