Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy (Intra-Op)

March 25, 2024 updated by: Don Moore, MD, University of Missouri-Columbia

Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy for Herniated Lumbar Discs Is There a Role? - A Randomized Control Trial

The purpose of this study is to determine a grading system for inflammation in lumbar disc herniation and which groups, if any, benefit most from the administration of an intra-operative epidural steroid.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Intraoperative epidural administration of steroids following discectomy for herniated lumbar disc has been the topic of multiple studies in the literature. The results have been mixed, with the majority of the studies finding some benefit, but outcomes have varied drastically amongst the many studies. The aim of this study is to develop a grading scale for intraoperative assessment of nerve root inflammation to determine if this subjective assessment is an adequate indicator for response to epidural steroids following discectomy. Patients will be allocated randomly preoperatively to the intervention group versus control group. Pictures of the spinal cord and associated nerve root will be captured intraoperatively. These pictures will be scrutinized postoperatively and an inflammation grade will be assigned. The investigators will then identify if nerve roots with a higher-grade of inflammation respond differently to epidural steroid administration when compared to lesser-grades of inflammation. This will be measured with the a variety of outcome measures.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65202
        • Recruiting
        • Missouri Orthopaedic Institute
        • Principal Investigator:
          • Don Moore, MD
        • Sub-Investigator:
          • Theodore Choma, MD
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Presenting to the University of Missouri hospital system - including the University of Missouri Hospital and Missouri Orthopaedic Institute - with a clinical assessment indicative of a lumbar disc herniation
  • Failed conservative treatment - rest, anti-inflammatory medications, physical therapy
  • Radiculopathy present - positive tension signs or sensory/motor neurologic deficits present
  • Recent MRI confirming single-level lumbar disc herniation corresponding to clinical evaluation

Exclusion Criteria:

  • Concomitant spinal stenosis, segmental instability, or spondylolisthesis
  • Previous surgery at the affected level or recurrent herniation
  • Underlying disease that may affect response to steroids - immunocompromise, use of chronic steroids or immunosuppression
  • Pregnancy - qualitative human chorionic gonadotropin (hCG) testing will be performed prior to enrollment
  • Diagnosis of or symptoms concerning for cauda equina syndrome

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
Placebo Comparator: Placebo Group
Patients in this group will be given the placebo (sterile saline).
Drug: saline 0.9%
Patients included in the placebo group will have their surgical site lavaged with sterile saline at the end of their surgery.
Other Names:
  • sterile saline
Active Comparator: Dexamethasone Group
Patients in this group will be given the study drug (dexamethasone).
Drug: Dexamethasone
Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.
Other Names:
  • Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative Pain Scores
Time Frame: Until final follow up (up to 8 weeks)
Comparing post operative pain scores between treatment and placebo group. Using Visual Analogue Scale (VAS) pain score with scale 0 to 10 with 0 being no pain and 10 being the worst pain of your life.
Until final follow up (up to 8 weeks)
Post Operative Oswestry Disability Index
Time Frame: Until final follow up (up to 8 weeks
Comparing post operative disability scores between treatment and placebo group. Using Oswestry Disability Index (ODI) to measure a patient's permanent functional disability and low back functional outcome tools.
Until final follow up (up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: Until final follow up (up to 8 weeks)
Determining how long patient is in hospital
Until final follow up (up to 8 weeks)
Post Operative Opioid Usage
Time Frame: Until final follow up (up to 8 weeks)
comparing opioid usage post operatively
Until final follow up (up to 8 weeks)
Post Operative Complications
Time Frame: Until final follow up (up to 8 weeks)
comparing rate of post-op infections
Until final follow up (up to 8 weeks)

Collaborators and Investigators

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

Sponsor

University of Missouri-Columbia

Investigators

  • Principal Investigator: Don Kim Moore, MD, Missouri Orthopaedic Institute

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)

November 21, 2019

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

November 25, 2019

First Submitted That Met QC Criteria

November 29, 2019

First Posted (Actual)

December 2, 2019

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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