RecruitingPhase 3NCT05058287

Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

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


Sponsor

Hospital for Special Surgery, New York

Enrollment

150 participants

Start Date

Nov 5, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether injecting a steroid (Depo-Medrol) into the surgical site during back surgery helps reduce pain and the need for opioid painkillers after a laminectomy — a procedure to relieve pressure on spinal nerves. The goal is to find better pain management options that reduce opioid use. You may be eligible if: - You are between 18 and 85 years old - You are scheduled to undergo a 1 to 2 level laminectomy (spinal decompression surgery) You may NOT be eligible if: - Your surgery will be minimally invasive - You have used opioids daily in the past 6 months - Your procedure includes spinal fusion or a revision surgery at the same level - You have a chronic pain syndrome, poorly controlled diabetes (HbA1c > 6.5), cancer treatment, history of organ transplant, enlarged prostate, or history of urinary retention - You are on chronic steroid therapy or immunosuppressants - You do not speak English - You are allergic to Depo-Medrol, glucocorticoids, or other steroids Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDepo-Medrol 40Mg/Ml Suspension for Injection

40mg Depo-Medrol mixed with hemostatic matrix

DRUGPlacebo

1 mL of sterile normal saline mixed with hemostatic matrix


Locations(1)

Hospital for Special Surgery

New York, New York, United States

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NCT05058287


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