Topical Epidural Steroid Usage in Patients Undergoing Posterior Lumbar Decompression: A Randomized Control Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Opioid use total [Both Groups]
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 2: Topical Normal Saline
Intervention: Placebo (Drug)
Group 1: Topical Steroid
Intervention: Depo-Medrol 40Mg/Ml Suspension for Injection (Drug)
Outcomes
Primary Outcomes
Opioid use total [Both Groups]
Time Frame: 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]
Time Frame: 3-Months Post-Op
Is participant still taking post-op opioids
Opioid use total [Both Groups]
Time Frame: In hospital, pre-discharge
Number \& dose of opioid taken converted to oral morphine equivalents post-operatively in hospital
Opioid consumption [Both Groups]
Time Frame: 6-Week Post-Op
Is participant still taking post-op opioids
Secondary Outcomes
- Re-admissions [Both Groups](3 Month)
- Veterans Rand 12-Item Health Survey [Both Groups](3 month post-op)
- Oswestry Low Back Pain Disability Questionnaire [Both Groups](3 month follow up)
- Numeric Rating Pain Scale [Both Groups](3-month follow up)
- Medical Complications [Both Groups](3 month follow up)
- Return to Work [Both Groups](3 month follow up)
- 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)
- Veterans Rand 12-Item Health Survey [Both Groups](pre-operative)
- Veterans Rand 12-Item Health Survey [Both Groups](2 week post-op)
- Veterans Rand 12-Item Health Survey [Both Groups](6 week post-op)
- Oswestry Low Back Pain Disability Questionnaire [Both Groups](pre-operative)
- Oswestry Low Back Pain Disability Questionnaire [Both Groups](2 week)
- Oswestry Low Back Pain Disability Questionnaire [Both Groups](6 week)
- Return to Work [Both Groups](2 week)
- Return to Work [Both Groups](6 week)
- Medical Complications [Both Groups](2 week)
- Medical Complications [Both Groups](6 week)
- Re-admissions [Both Groups](2 Week)
- Re-admissions [Both Groups](6 Week)