NCT04212845

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

January 2, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

December 25, 2019

Last Update Submit

January 4, 2020

Conditions

Discogenic Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Oswestry Disability Index

    Post injection first, third and sixth month

Study Arms (2)

Group ESP

ACTIVE COMPARATOR

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

Drug: Bupivacaine;Dexamethasone Solution for InjectionDevice: Ultrasound

Group TF

ACTIVE COMPARATOR

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

Drug: Bupivacaine;Dexamethasone Solution for InjectionDevice: Fluoroscopy

Interventions

Bupivacaine;Dexamethasone Solution for InjectionDRUG

8 mg Dexamethasone and %0.25 bupivacaine

Group ESPGroup TF
FluoroscopyDEVICE

Fluoroscopy-guided transforaminal injection

Group TF
UltrasoundDEVICE

Ultrasound-guided erector spinae plane block

Group ESP

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologist's physiologic state I-III patients
  • Patients with unilateral radicular pain and low back pain persisting despite medical treatment.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 30992410BACKGROUND

  • 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.

    PMID: 31775403BACKGROUND

MeSH Terms

Interventions

InjectionsFluoroscopyUltrasonography

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Ahmet Yayik, MD

CONTACT

00905544259287m_yayik@hotmail.com

Ali Ahiskalioglu, MD

CONTACT

00905444424831aliahiskalioglu@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 25, 2019

First Posted

December 30, 2019

Study Start

January 2, 2020

Primary Completion

June 1, 2020

Study Completion

September 1, 2020

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

TU(1)