Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

Part of paid clinical trials in New York, New York.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT05058287
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 5, 2021
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Topical Steroid
  • Placebo Comparator: Group 2: Topical Normal Saline

Primary Outcome Measure

Opioid use total [Both Groups] [ Time Frame: In hospital, pre-discharge ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital for Special SurgeryNew YorkNew York10021
Matthew Cunningham, MD, PhD

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