Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-05

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Erector Spinae Plan Block (ESPB) with Dexmedetomidine and Dexamethasone in Lumbar Spine Fusion

NCT06658054

Lumbar Degenerative Disease

NOT_YET_RECRUITING PHASE4

Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy

NCT04182997

Lumbar Disc Herniation

RECRUITING PHASE4

Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain

NCT00370799

Low Back Pain

COMPLETED EARLY_PHASE1

Perioperative Outcome of Corticosteroids in Transforaminal Endoscopic Lumbar Discectomy

NCT03273036

Lumbar Disc Herniation

COMPLETED PHASE4

Epidural Steroid Following Discectomy for Herniated Disc Reduces Morbidity

NCT01499641

Disc Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Use Lumbar Spinal Stenosis Pain, Postoperative Pain, Back

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1: Topical Steroid

Group Type EXPERIMENTAL

Depo-Medrol 40Mg/Ml Suspension for Injection

Intervention Type DRUG

40mg Depo-Medrol mixed with hemostatic matrix

Group 2: Topical Normal Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 mL of sterile normal saline mixed with hemostatic matrix

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Depo-Medrol 40Mg/Ml Suspension for Injection

40mg Depo-Medrol mixed with hemostatic matrix

Intervention Type DRUG

Placebo

1 mL of sterile normal saline mixed with hemostatic matrix

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No