Erector Spinae Plane Block vs Transforaminal Epidural Injection

Study Overview
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Brief Summary
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Lumbar disc herniation is the main cause of low back pain and radicular leg pain. Steroids administered to the epidural area reduce the inflammatory response and pain by inhibiting the synthesis of proinflammatory agents. Epidural steroid injections are used in the treatment of lumbosacral radicular pain with various techniques including fluoroscopy-guided transforaminal and interlaminar injection. Ultrasound-guided erector spina plan block (ESPB) was first described in 2016 and has been used for postoperative analgesia in many surgeries including thoracic and lumbar dermatomes. The distribution of local anesthesia in the ESPB from the paravertebral area to the transforaminal and epidural space has been shown in studies. The aim of this study was to compare the efficacy of ultrasound-guided ESPB and fluoroscopic guided transforaminal epidural steroid injection in chronic discogenic low back pain.

Official Title
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Erector Spinae Plane Block Versus Transforaminal Epidural Injection in Chronic Discogenic Low Back Pain

Conditions
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Discogenic Low Back Pain

Intervention / Treatment
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* Drug: Bupivacaine;Dexamethasone Solution for Injection
* Device: Fluoroscopy
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-III patients Patients with unilateral radicular pain and low back pain persisting despite medical treatment. Exclusion Criteria: Spinal cord disease or spinal mechanical instability, Previous low back surgery, More than two levels of lumbar disc hernia, Allergic to local anesthetic drugs to be used, Use of oral anticoagulants, Uncontrolled diabetes mellitus type I and II

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group ESP<br>Ultrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine and 8 mg dexamethasone | Drug: Bupivacaine;Dexamethasone Solution for Injection<br>* 8 mg Dexamethasone and %0.25 bupivacaine<br>Device: Ultrasound<br>* Ultrasound-guided erector spinae plane block<br>|
| Active Comparator: Group TF<br>Fluoroscopy-guided transforaminal injection with 4 ml of 0.25% bupivacaine and 8 mg dexamethasone | Drug: Bupivacaine;Dexamethasone Solution for Injection<br>* 8 mg Dexamethasone and %0.25 bupivacaine<br>Device: Fluoroscopy<br>* Fluoroscopy-guided transforaminal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain score | Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) | Post injection sixth month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index | 0% -20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms. | Post injection first, third and sixth month |