Randomized Controlled Trial of Postoperative Inpatient Ketorolac and Outpatient Naproxen Use Following Elective Lumbar Spine Fusion
Overview
- Phase
- Phase 4
- Intervention
- Naproxen 500 Mg
- Conditions
- Spine Fusion
- Sponsor
- Rothman Institute Orthopaedics
- Enrollment
- 428
- Locations
- 1
- Primary Endpoint
- Fusion failure
- Status
- Enrolling by Invitation
- Last Updated
- last year
Overview
Brief Summary
The purpose of this randomized controlled trial is to determine if patients who receive non-steroidal anti-inflammatory medications (NSAIDs) following elective lumbar spinal fusion have increased rates of symptomatic nonunion requiring revision spinal surgery at two-years follow-up, compared to those who do not receive NSAIDs.
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥18 years of age, ≥1-level planned lumbar spinal fusion
- •Capacity to enroll
- •English speaking
Exclusion Criteria
- •Chronic kidney disease (preoperative creatinine ≥1.4)
- •History of gastrointestinal bleed or peptic ulcer disease
- •History of spinal fusion nonunion
- •Non-steroidal anti-inflammatory drug allergy
- •Previously diagnosed coagulopathy
- •Preoperative thrombocytopenia (platelets \<100,000)
- •Connective tissue disease
- •Operative indication due to infection, neoplasm, or trauma
- •Currently pregnant
Arms & Interventions
Group 1: NSAID Group
Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery
Intervention: Naproxen 500 Mg
Group 1: NSAID Group
Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery
Intervention: Ketorolac
Group 1: NSAID Group
Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery
Intervention: OxyCODONE 5 mg Oral Tablet
Group 1: NSAID Group
Participants in the NSAID group will receive NSAIDs in addition to our standard postoperative regimen after their Lumbar spine fusion surgery
Intervention: Metaxalone 800 MG
Group 2: Control Group
Participants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery
Intervention: OxyCODONE 5 mg Oral Tablet
Group 2: Control Group
Participants in the control group will only receive our standard postoperative regimen after their Lumbar spine fusion surgery
Intervention: Metaxalone 800 MG
Outcomes
Primary Outcomes
Fusion failure
Time Frame: 2 years
Failure of fusion surgery will be measured by the rate of revisions as demonstrated by participant x-rays