Erector Spinae Plane Block vs Transforaminal Epidural Injection

Not Applicable

• Conditions: Discogenic Low Back Pain
• Interventions: Drug: Bupivacaine;Dexamethasone Solution for Injection; Device: Fluoroscopy; Device: Ultrasound

• Registration Number: NCT04212845
• Lead Sponsor: Ataturk University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-25
• Study First Submitted QC: 2019-12-25
• Study First Posted: 2019-12-30
• Status Verified: 2020-01
• Study Start: 2020-01-02
• Last Update Submitted: 2020-01-04
• Last Update Posted: 2020-01-07
• Primary Completion: 2020-06-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group TF	Bupivacaine;Dexamethasone Solution for Injection	Fluoroscopy-guided transforaminal injection with 4 ml of 0.25% bupivacaine and 8 mg dexamethasone
Group TF	Fluoroscopy	Fluoroscopy-guided transforaminal injection with 4 ml of 0.25% bupivacaine and 8 mg dexamethasone
Group ESP	Bupivacaine;Dexamethasone Solution for Injection	Ultrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine and 8 mg dexamethasone
Group ESP	Ultrasound	Ultrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine and 8 mg dexamethasone

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index	Post injection first, third and sixth month	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.

Trial Locations

Locations (1)

Ataturk University; 🇹🇷 Erzurum, Turkey