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Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

Recruiting
18-85 years
All
Phase 3

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Overview

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.

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

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

Study details
    Opioid Use
    Lumbar Spinal Stenosis
    Pain
    Postoperative
    Pain
    Back

NCT05058287

Hospital for Special Surgery, New York

13 April 2024

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