Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

Phase 3

Recruiting

• Conditions: Pain, Back; Lumbar Spinal Stenosis; Opioid Use; Pain, Postoperative
• Interventions: Drug: Placebo; Drug: Depo-Medrol 40Mg/Ml Suspension for Injection

• Registration Number: NCT05058287
• Lead Sponsor: Hospital for Special Surgery, New York

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.

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.

Study Timeline

• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-27
• Study Start: 2021-11-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Topical Normal Saline	Placebo	-
Group 1: Topical Steroid	Depo-Medrol 40Mg/Ml Suspension for Injection	-

Primary Outcome Measures

Name	Time	Method
Opioid use total [Both Groups]	Every day for 14 days post- discharge	Number \& dose of opioid taken converted to oral morphine equivalents post-operatively post-discharge
Opioid consumption [Both Groups]	3-Months Post-Op	Is participant still taking post-op opioids

Secondary Outcome Measures

Name	Time	Method
Re-admissions [Both Groups]	3 Month	Any re-admissions
Veterans Rand 12-Item Health Survey [Both Groups]	3 month post-op	Change in baseline pain as measured through VR-12
Oswestry Low Back Pain Disability Questionnaire [Both Groups]	3 month follow up	Change in baseline pain as measured through ODI
Numeric Rating Pain Scale [Both Groups]	3-month follow up	Change in baseline pain as measured through the NRS Scale: 0-10 0: None; 1,2,3: Mild; 4,5,6: Moderate; 7,8,9,10: Severe
Medical Complications [Both Groups]	3 month follow up	Any medical complications
Return to Work [Both Groups]	3 month follow up	Date participant returned to work

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States