Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Opioid Use, Lumbar Spinal Stenosis, Pain, Postoperative, Pain, Back

Intervention / Treatment
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* Drug: Depo-Medrol 40Mg/Ml Suspension for Injection
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |