Erector Spinae Plane Block vs Transforaminal Epidural Injection

January 4, 2020 updated by: Ahmet Murat Yayik, Ataturk University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey
        • Recruiting
        • Ataturk University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog pain score
Time Frame: 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)
Post injection sixth month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: 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.
Post injection first, third and sixth month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2020

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

December 25, 2019

First Submitted That Met QC Criteria

December 25, 2019

First Posted (Actual)

December 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 4, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESPB vs TF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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