Spine Fusion, NSAID (Non-Steroidal Anti-Inflammatory Drug), Postoperative Pain
Conditions
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.
Interventions
DRUGNaproxen 500 Mg
participants will receive Naproxen (500 mg) to take for 7 days after surgery as needed
DRUGKetorolac
participants will receive Ketorolac (15 mg) immediately after surgery
participants will receive OxyCODONE (5 mg) to take for 7 days after surgery as needed
DRUGMetaxalone 800 MG
participants will receive Metaxalone (800 MG) to take for 7 days after surgery as needed
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fusion failure | 2 years | Failure of fusion surgery will be measured by the rate of revisions as demonstrated by participant x-rays |
Countries
United States
Outcome results
None listed