Using steroids during lumbar surgery to reduce pain and opioid use
Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial
This study tests if using steroids during back surgery can help reduce pain and the need for opioids in patients recovering from the procedure.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Hospital for Special Surgery, New York Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05058287 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of intra-operative topical epidural steroid application in patients undergoing 1- to 2-level lumbar laminectomies. Participants will be randomly assigned to receive either 40 mg of Depo-Medrol or a placebo saline solution applied to the surgical site before closure. The study will track post-operative opioid consumption, length of hospital stay, return to work, and patient-reported outcomes over a three-month period. Assessments will occur pre-operatively, during hospitalization, and at follow-up intervals of two weeks, one month, and three months post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 scheduled for 1-2 level lumbar laminectomy.
Not a fit: Patients with a history of chronic pain syndromes or those requiring chronic steroid therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative pain and opioid dependency in patients undergoing lumbar surgery.
How similar studies have performed: Previous studies have shown promising results with steroid use in similar surgical contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled to undergo 1 to 2 level laminectomy * Between the ages of 18-85 Exclusion Criteria: * Minimally invasive surgery * Prior daily opioid usage within 6 months. * Use of concomitant procedures such as spinal fusion, revision procedure at the same level. * History of a chronic pain syndrome, uncontrolled diabetes defined as A1C \> 6.5, immunocompromised condition such as active cancer treatment, history of transplant, benign prostatic hyperplasia or history of urinary retention, and other conditions which require chronic steroid therapy or immunosuppressants. * Non-English speakers * Patients allergic to Depo-Medrol and/or glucocorticoids, or other steroids
Where this trial is running
New York, New York
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Catherine Himo Gang, MPH
- Email: gangh@hss.edu
- Phone: (917) 623-5416
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.