Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Catherine Himo Gang, MPH; Phone Number: (917) 623-5416; Email: gangh@hss.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Hospital for Special Surgery
      • Contact: Matthew Cunningham, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Topical Steroid	Drug: Depo-Medrol 40Mg/Ml Suspension for Injection; 40mg Depo-Medrol mixed with hemostatic matrix
Placebo Comparator: Group 2: Topical Normal Saline	Drug: Placebo; 1 mL of sterile normal saline mixed with hemostatic matrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Pain Scale [Both Groups]	Baseline pain as measured through the NRS 0: None; 1,2,3: Mild; 4,5,6: Moderate; 7,8,9,10: Severe	pre-operative
Numeric Rating Pain Scale [Both Groups]	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;	every day for 14 days post-op
Numeric Rating Pain Scale [Both Groups]	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	6-week
Numeric Rating Pain Scale [Both Groups]	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	3-month follow up
Veterans Rand 12-Item Health Survey [Both Groups]	Baseline pain as measured through VR-12	pre-operative
Veterans Rand 12-Item Health Survey [Both Groups]	Change in baseline pain as measured through VR-12	2 week post-op
Veterans Rand 12-Item Health Survey [Both Groups]	Change in baseline pain as measured through VR-12	6 week post-op
Veterans Rand 12-Item Health Survey [Both Groups]	Change in baseline pain as measured through VR-12	3 month post-op
Oswestry Low Back Pain Disability Questionnaire [Both Groups]	Baseline pain as measured through ODI	pre-operative
Oswestry Low Back Pain Disability Questionnaire [Both Groups]	Change in baseline pain as measured through ODI	2 week
Oswestry Low Back Pain Disability Questionnaire [Both Groups]	Change in baseline pain as measured through ODI	6 week
Oswestry Low Back Pain Disability Questionnaire [Both Groups]	Change in baseline pain as measured through ODI	3 month follow up
Return to Work [Both Groups]	Date participant returned to work	2 week
Return to Work [Both Groups]	Date participant returned to work	6 week
Return to Work [Both Groups]	Date participant returned to work	3 month follow up
Medical Complications [Both Groups]	Any medical complications	2 week
Medical Complications [Both Groups]	Any medical complications	6 week
Medical Complications [Both Groups]	Any medical complications	3 month follow up
Re-admissions [Both Groups]	Any re-admissions	2 Week
Re-admissions [Both Groups]	Any re-admissions	6 Week
Re-admissions [Both Groups]	Any re-admissions	3 Month

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Spinal Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Pain, Postoperative; Spinal Stenosis; Pharmaceutical Preparations; Therapeutics; Dosage Forms; Drug Administration Routes; Drug Therapy; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Complex Mixtures; Colloids; Methylprednisolone; Prednisolone; Methylprednisolone Acetate; Injections; Suspensions
• Other Study ID Numbers: 2020-0041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to share de-identified data after all study related activities are completed.
• IPD Sharing Time Frame: We plan to share de-identified data after all study related activities are completed for a minimum of 1 year.
• IPD Sharing Access Criteria: The data will be posted through PRS
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes