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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Chronic

Intervention / Treatment
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* Procedure: Erector spinae plane block
* Procedure: cervical epidural injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high thoracic ESPB group<br>Group where ESPB is performed at T2 with local anesthetic mixture 20 ml | Procedure: Erector spinae plane block<br>* fascial plane injection guided by ultrasound guidance<br>|
| Active Comparator: cervical epidural group<br>Group where cervical epidural injection is performed at C6-7 or C7-T1 level | Procedure: cervical epidural injection<br>* cervical epidural injection by fluoroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of numerical rating scale | Changes of 11-point numerical rating scale (0-10) | baseline, 10 min after injection, 1wk after injection, 2 wks after injection, 4 wks after injection, 8 wks after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of neck disability index | Changes of back pain funtional scale | baseline, 8 wks after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, lumbar