Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

Phase 3RecruitingNCT05058287

Hospital for Special Surgery, New York150 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Opioid Use Lumbar Spinal Stenosis Pain, Postoperative Pain, Back

Interventions

Depo-Medrol 40Mg/Ml Suspension for InjectionDRUG

40mg Depo-Medrol mixed with hemostatic matrix

PlaceboDRUG

1 mL of sterile normal saline mixed with hemostatic matrix

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital for Special Surgery

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

Opioid use total [Both Groups]

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

Time frame: In hospital, pre-discharge

Opioid use total [Both Groups]

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

Time frame: Every day for 14 days post- discharge

Opioid consumption [Both Groups]

Is participant still taking post-op opioids

Time frame: 6-Week Post-Op

Opioid consumption [Both Groups]

Is participant still taking post-op opioids

Time frame: 3-Months Post-Op

Secondary Outcomes

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

Time frame: 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;

Time frame: 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

Time frame: 6-week

Numeric Rating Pain Scale [Both Groups]

Central Contacts

Catherine Himo Gang, MPH

CONTACT

(917) 623-5416 gangh@hss.edu

Data from ClinicalTrials.gov

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