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Recruiting NCT05058287

Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

Phase III Interventional Opioid Use Lumbar Spinal Stenosis Pain, Postoperative Pain, Back

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Depo-Medrol 40Mg/Ml Suspension for Injection, Placebo.
Who it may be relevant to
Registry conditions: Opioid Use, Lumbar Spinal Stenosis, Pain, Postoperative, Pain, Back. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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.

Interventions

  • 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

Primary outcome measures

  • Opioid use total [Both Groups] [Time frame: In hospital, pre-discharge]
  • Opioid use total [Both Groups] [Time frame: Every day for 14 days post- discharge]
  • Opioid consumption [Both Groups] [Time frame: 6-Week Post-Op]
  • Opioid consumption [Both Groups] [Time frame: 3-Months Post-Op]
Secondary outcome measures (12)
  • Numeric Rating Pain Scale [Both Groups] [Time frame: pre-operative]
  • Numeric Rating Pain Scale [Both Groups] [Time frame: every day for 14 days post-op]
  • Numeric Rating Pain Scale [Both Groups] [Time frame: 6-week]
  • Numeric Rating Pain Scale [Both Groups] [Time frame: 3-month follow up]
  • Veterans Rand 12-Item Health Survey [Both Groups] [Time frame: pre-operative]
  • Veterans Rand 12-Item Health Survey [Both Groups] [Time frame: 2 week post-op]
  • Veterans Rand 12-Item Health Survey [Both Groups] [Time frame: 6 week post-op]
  • Veterans Rand 12-Item Health Survey [Both Groups] [Time frame: 3 month post-op]
  • Oswestry Low Back Pain Disability Questionnaire [Both Groups] [Time frame: pre-operative]
  • Oswestry Low Back Pain Disability Questionnaire [Both Groups] [Time frame: 2 week]
  • Oswestry Low Back Pain Disability Questionnaire [Both Groups] [Time frame: 6 week]
  • Oswestry Low Back Pain Disability Questionnaire [Both Groups] [Time frame: 3 month follow up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Hospital for Special Surgery — New York

Identifiers

NCT: NCT05058287 · 2020-0041

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗