Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

NCT05058287 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 2020-0041
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Opioid use total [Both Groups]

  Number \& dose of opioid taken converted to oral morphine equivalents post-operatively in hospital

  In hospital, pre-discharge

• Opioid use total [Both Groups]

  Number \& dose of opioid taken converted to oral morphine equivalents post-operatively post-discharge

  Every day for 14 days post- discharge

• Opioid consumption [Both Groups]

  Is participant still taking post-op opioids

  6-Week Post-Op

• Opioid consumption [Both Groups]

  Is participant still taking post-op opioids

  3-Months Post-Op

Secondary Outcomes (21)

• Numeric Rating Pain Scale [Both Groups]

  pre-operative

• Numeric Rating Pain Scale [Both Groups]

  every day for 14 days post-op

• Numeric Rating Pain Scale [Both Groups]

  6-week

• Numeric Rating Pain Scale [Both Groups]

  3-month follow up

• Veterans Rand 12-Item Health Survey [Both Groups]

  pre-operative

Study Arms (2)

Group 1: Topical Steroid

EXPERIMENTAL

Drug: Depo-Medrol 40Mg/Ml Suspension for Injection

Group 2: Topical Normal Saline

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Depo-Medrol 40Mg/Ml Suspension for Injection DRUG

40mg Depo-Medrol mixed with hemostatic matrix

Group 1: Topical Steroid

Placebo DRUG

1 mL of sterile normal saline mixed with hemostatic matrix

Group 2: Topical Normal Saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo 1 to 2 level laminectomy
• Between the ages of 18-85

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis; Pain, Postoperative; Back Pain

Interventions

Methylprednisolone Acetate; Suspensions; Injections

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Catherine Himo Gang, MPH

CONTACT

(917) 623-5416; gangh@hss.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: September 27, 2021
• Study Start: November 5, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: We plan to share de-identified data after all study related activities are completed for a minimum of 1 year.
• Access Criteria: The data will be posted through PRS

Locations

US (1)