Comparison of Pain Relief After Upper and Lower Lumbar Erector Spinae Plane Block

Study Overview
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Brief Summary
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The primary endpoint of this study was to identify if eretor spinae plane block (ESPB) has any effect in relieving low back pain or leg pain in lumbar radiculopathy. The secondary endpoint was to compare the number of spread level when upper or lower lumbar ESPB was performed.

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. Therefore, the exact spread level of injected local anesthetics remains unclear and a study on a large number of patients is still required

Official Title
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Comparison of Pain Relief and Spread Level in Upper and Lower Lumbar Erector Spinae Plane Block

Conditions
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Pain, Chronic

Intervention / Treatment
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* Procedure: Erector spinae plane block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lumbar disc herniation lumbar foraminal stenosis lumbar central stenosis lumbar spondylolisthesis severe level of spine at L3-4 numerical rating scale > 4 back pain functional scale < 45 duration of pain > 1 month patients who can fully understand all items described in BPFS Exclusion Criteria: Allergy to local anesthetics or contrast medium Pregnancy Spine deformity Prior history of lumbar spine surgery No previous lumbar MRI or CT Patients with coagulation abnormality Incorrect level of ESPB

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: upper lumbar ESPB group<br>Group where ESPB is performed at L2 with local anesthetic mixture 20 ml | Procedure: Erector spinae plane block<br>* fascial plane injection guided by fluoroscopy device<br>|
| Active Comparator: lower lumbar ESPB group<br>Group where ESPB is performed at L4 with local anesthetic mixture 20 ml | Procedure: Erector spinae plane block<br>* fascial plane injection guided by fluoroscopy device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical rating scale changes among 5 times period | numerical rating scale changes after ESPB among 5 times period | baseline, 10 minutes after ESPB, 1 week after ESPB, 2 weeks after ESPB, 4 weeks after ESPB | 
| back pain function scale changes among 2 times period | back pain function scale changes after ESPB among 2 times period | baseline, 4 weeks after ESPB | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spread level in the cranio-caudal direction | fluoroscopic contrast medium spread level in the cranio-caudal direction | baseline, 1 minute after ESPB | 

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