Actively Recruiting
Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial
Led by Hospital for Special Surgery, New York · Updated on 2026-04-28
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of using topical epidural steroids during surgery for patients undergoing 1- to 2-level lumbar laminectomy. This randomized controlled trial compares the application of 40 mg Depo-Medrol steroid versus sterile normal saline to the surgical wound before closure. The study aims to understand how these treatments affect post-operative opioid use, hospital stay length, return to work, and patient-reported outcomes. Participants are randomly assigned to receive either the steroid Depo-Medrol mixed with a hemostatic matrix or a placebo of sterile normal saline with the matrix applied during surgery. The study includes pre-operative assessment, daily monitoring during hospital stay and for two weeks after discharge, and follow-up visits at 1 and 3 months post-surgery. Both groups are closely observed to compare recovery and pain management outcomes. During the study, participants undergo assessments including opioid consumption tracking, pain rating scales, health surveys, and disability questionnaires before surgery and at multiple points afterward. Researchers also monitor medical complications, hospital readmissions, and return-to-work status. The total participation duration covers pre-surgery evaluation through a three-month follow-up period to capture recovery and treatment effects comprehensively.
CONDITIONS
Brief Title
Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled to undergo 1 to 2 level laminectomy
- Between the ages of 18-85
You will not qualify if you...
- Minimally invasive surgery
- Prior daily opioid usage within 6 months
- Use of concomitant procedures such as spinal fusion or revision at the same level
- History of chronic pain syndrome
- Uncontrolled diabetes defined as A1C > 6.5
- Immunocompromised condition such as active cancer treatment or history of transplant
- Benign prostatic hyperplasia or history of urinary retention
- Conditions requiring chronic steroid therapy or immunosuppressants
- Non-English speakers
- Allergy to Depo-Medrol and/or glucocorticoids or other steroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (surgery day)
Participants undergo posterior lumbar decompression surgery and receive either topical epidural steroid or placebo applied to the surgical wound prior to closure.
1 hospital admission visit
Duration - 2 weeks plus follow-up at 1 and 3 months
Participants are monitored daily for two weeks after surgery, and then assessed at 1 month and 3 months to evaluate recovery, opioid use, pain, and function.
Daily visits for 14 days post-discharge, plus 2 follow-up visits at 1 and 3 months
Trial Site Locations
Total: 1 location
1
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
Research Team
C
Catherine Himo Gang, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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