NCT05058287

Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to evaluate the impact of intra-operative topical epidural steroid usage in patients undergoing 1-2 level lumbar laminectomy. The study will examine post-operative opioid usage, length of stay, return to work, and patient reported outcomes following these procedures.

Detailed description

This is a randomized controlled trial seeking to evaluate the impact of intra-operative topical epidural steroid usage in patients undergoing 1- to 2- level lumbar laminectomies. Subjects enrolled in this study will be randomized to one of two treatments: either 40 mg Depo-Medrol or 1 mL of sterile normal saline will be applied to the surgical wound prior to closure. The study will examine post-operative opioid usage, length of stay, return to work, and patient reported outcomes following these procedures. Subjects will be assessed pre-operatively, while admitted for surgery, and postoperatively daily for two weeks, then again at 1- and 3- months.

Conditions

• Opioid Use
• Lumbar Spinal Stenosis
• Pain, Postoperative
• Pain, Back

Interventions

Type	Name	Description
DRUG	Depo-Medrol 40Mg/Ml Suspension for Injection	40mg Depo-Medrol mixed with hemostatic matrix
DRUG	Placebo	1 mL of sterile normal saline mixed with hemostatic matrix

Timeline

• Start date: 2021-11-05
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-09-27
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study