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NCT05058287PHASE3Recruiting

Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

Hospital for Special Surgery, New York

Start Date

11/5/2021

Completion Date

12/31/2026

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.

Eligibility Criteria

Age Range: 18 years to 85 years

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

Interventions

DRUG

Depo-Medrol 40Mg/Ml Suspension for Injection

DRUG

Placebo

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Conditions

Opioid UseLumbar Spinal StenosisPain, PostoperativePain, Back

Locations

Hospital for Special Surgery

New York, New York 10021

United States