Using epidural steroids during surgery for lumbar disc herniation
Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy for Herniated Lumbar Discs Is There a Role? - A Randomized Control Trial
PHASE4 · University of Missouri-Columbia · NCT04182997
This study is testing if giving steroids during back surgery for a herniated disc can help reduce inflammation and improve recovery compared to a placebo.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Missouri-Columbia (other) |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT04182997 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a grading system for inflammation in patients undergoing discectomy for lumbar disc herniation and to evaluate the effectiveness of intraoperative epidural steroid administration. Patients will be randomly assigned to receive either dexamethasone or saline during surgery. Intraoperative images of the spinal cord and nerve roots will be analyzed postoperatively to assign an inflammation grade. The study will assess whether higher inflammation grades correlate with better outcomes from steroid administration compared to lower grades.
Who should consider this trial
Good fit: Ideal candidates are individuals presenting with lumbar disc herniation who have failed conservative treatments and exhibit radiculopathy.
Not a fit: Patients with conditions such as spinal stenosis, previous surgeries at the affected level, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and recovery outcomes for patients undergoing discectomy for lumbar disc herniation.
How similar studies have performed: Previous studies on intraoperative steroid administration have shown mixed results, indicating that this approach is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Columbia, Missouri
- Missouri Orthopaedic Institute — Columbia, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Don Kim Moore, MD — Missouri Orthopaedic Institute
- Study coordinator: Vickci Jones, MEd, CCRP
- Email: jonesvicki@health.missouri.edi
- Phone: (573) 882-7583
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lumbar Disc Herniation