Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Group 1: Topical Steroid
|
Drug: Depo-Medrol 40Mg/Ml Suspension for Injection
40mg Depo-Medrol mixed with hemostatic matrix
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Placebo Comparator: Group 2: Topical Normal Saline
|
Drug: Placebo
1 mL of sterile normal saline mixed with hemostatic matrix
|
Outcome Measures
Primary Outcome Measures
- Opioid use total [Both Groups] [In hospital, pre-discharge]
Number & dose of opioid taken converted to oral morphine equivalents post-operatively in hospital
- Opioid use total [Both Groups] [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] [6-Week Post-Op]
Is participant still taking post-op opioids
- Opioid consumption [Both Groups] [3-Months Post-Op]
Is participant still taking post-op opioids
Secondary Outcome Measures
- Numeric Rating Pain Scale [Both Groups] [pre-operative]
Baseline pain as measured through the NRS 0: None; 1,2,3: Mild; 4,5,6: Moderate; 7,8,9,10: Severe
- Numeric Rating Pain Scale [Both Groups] [every day for 14 days post-op]
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;
- Numeric Rating Pain Scale [Both Groups] [6-week]
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
- Numeric Rating Pain Scale [Both Groups] [3-month follow up]
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
- Veterans Rand 12-Item Health Survey [Both Groups] [pre-operative]
Baseline pain as measured through VR-12
- Veterans Rand 12-Item Health Survey [Both Groups] [2 week post-op]
Change in baseline pain as measured through VR-12
- Veterans Rand 12-Item Health Survey [Both Groups] [6 week post-op]
Change in baseline pain as measured through VR-12
- Veterans Rand 12-Item Health Survey [Both Groups] [3 month post-op]
Change in baseline pain as measured through VR-12
- Oswestry Low Back Pain Disability Questionnaire [Both Groups] [pre-operative]
Baseline pain as measured through ODI
- Oswestry Low Back Pain Disability Questionnaire [Both Groups] [2 week]
Change in baseline pain as measured through ODI
- Oswestry Low Back Pain Disability Questionnaire [Both Groups] [6 week]
Change in baseline pain as measured through ODI
- Oswestry Low Back Pain Disability Questionnaire [Both Groups] [3 month follow up]
Change in baseline pain as measured through ODI
- Return to Work [Both Groups] [2 week]
Date participant returned to work
- Return to Work [Both Groups] [6 week]
Date participant returned to work
- Return to Work [Both Groups] [3 month follow up]
Date participant returned to work
- Medical Complications [Both Groups] [2 week]
Any medical complications
- Medical Complications [Both Groups] [6 week]
Any medical complications
- Medical Complications [Both Groups] [3 month follow up]
Any medical complications
- Re-admissions [Both Groups] [2 Week]
Any re-admissions
- Re-admissions [Both Groups] [6 Week]
Any re-admissions
- Re-admissions [Both Groups] [3 Month]
Any re-admissions
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients scheduled to undergo 1 to 2 level laminectomy
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Between the ages of 18-85
Exclusion Criteria:
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Minimally invasive surgery
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Prior daily opioid usage within 6 months.
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Use of concomitant procedures such as spinal fusion, revision procedure at the same level.
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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.
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Non-English speakers
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Patients allergic to Depo-Medrol and/or glucocorticoids, or other steroids
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hospital for Special Surgery | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Hospital for Special Surgery, New York
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-0041