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Erector Spinae Plane Block vs Transforaminal Epidural Injection

Primary Purpose

Discogenic Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine;Dexamethasone Solution for Injection
Fluoroscopy
Ultrasound
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Discogenic Low Back Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ataturk UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group ESP

Group TF

Arm Description

Ultrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine and 8 mg dexamethasone

Fluoroscopy-guided transforaminal injection with 4 ml of 0.25% bupivacaine and 8 mg dexamethasone

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
December 25, 2019
Last Updated
January 4, 2020
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT04212845
Brief Title
Erector Spinae Plane Block vs Transforaminal Epidural Injection
Official Title
Erector Spinae Plane Block Versus Transforaminal Epidural Injection in Chronic Discogenic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discogenic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group ESP
Arm Type
Active Comparator
Arm Description
Ultrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine and 8 mg dexamethasone
Arm Title
Group TF
Arm Type
Active Comparator
Arm Description
Fluoroscopy-guided transforaminal injection with 4 ml of 0.25% bupivacaine and 8 mg dexamethasone
Intervention Type
Drug
Intervention Name(s)
Bupivacaine;Dexamethasone Solution for Injection
Intervention Description
8 mg Dexamethasone and %0.25 bupivacaine
Intervention Type
Device
Intervention Name(s)
Fluoroscopy
Intervention Description
Fluoroscopy-guided transforaminal injection
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound-guided erector spinae plane block
Primary Outcome Measure Information:
Title
Visual analog pain score
Description
Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)
Time Frame
Post injection sixth month
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
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.
Time Frame
Post injection first, third and sixth month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmet Yayik, MD
Phone
00905544259287
Email
m_yayik@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ahiskalioglu, MD
Phone
00905444424831
Email
aliahiskalioglu@hotmail.com
Facility Information:
Facility Name
Ataturk University
City
Erzurum
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmet Murat Yayik, MD
Phone
00905544259287
Email
m_yayik@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
30992410
Citation
Celik M, Tulgar S, Ahiskalioglu A, Alper F. Is high volume lumbar erector spinae plane block an alternative to transforaminal epidural injection? Evaluation with MRI. Reg Anesth Pain Med. 2019 Apr 16:rapm-2019-100514. doi: 10.1136/rapm-2019-100514. Online ahead of print. No abstract available.
Results Reference
background
PubMed Identifier
31775403
Citation
Makkar JK, Gourav KKP, Jain K, Singh PM, Dhatt SS, Sachdeva N, Bhadada S. Transforaminal Versus Lateral Parasagittal Versus Midline Interlaminar Lumbar Epidural Steroid Injection for Management of Unilateral Radicular Lumbar Pain: A Randomized Double-Blind Trial. Pain Physician. 2019 Nov;22(6):561-573.
Results Reference
background

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Erector Spinae Plane Block vs Transforaminal Epidural Injection

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