Recruiting
Phase 3

Lumbar Steroid

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT05058287

Conditions

Opioid Use

Lumbar Spinal Stenosis

Pain, Postoperative

Pain, Back

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Depo-Medrol 40Mg/Ml Suspension for Injection

Placebo

Study Details

Brief 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.

Conditions

Opioid Use

Lumbar Spinal Stenosis

Pain, Postoperative

Pain, Back

Study ID

NCT05058287

Start date

Nov 5, 2021

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: Topical Steroid

placebo comparator: Group 2: Topical Normal Saline

Interventions

Depo-Medrol 40Mg/Ml Suspension for Injection

40mg Depo-Medrol mixed with hemostatic matrix

Placebo

1 mL of sterile normal saline mixed with hemostatic matrix

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Catherine Himo Gang, MPH

(917) 623-5416gangh@hss.edu

Locations

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Apr 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2026-04-28.