NSAIDS Following Elective Lumbar Spine Fusion
Enrolling by invitation · Phase 3 · Has a placebo group
Conditions studied: NSAID (Non-Steroidal Anti-Inflammatory Drug), Lumbar Spine Fusion, Ketorolac, Postoperative Pain
In brief
This study will compare two common approaches to pain control after lumbar spinal fusion surgery. Participants will be randomly assigned to receive either standard pain medication alone or standard pain medication plus a short course of nonsteroidal anti-inflammatory drugs (NSAIDs), including intravenous ketorolac while in the hospital and oral naproxen for one week after discharge. The main goal is to determine whether taking NSAIDs after surgery affects how well the spine heals by increasing the chance of needing another surgery because the bones did not fuse properly within 2 years. The study will also evaluate pain medication use, recovery, hospital readmissions, complications, physical therapy progress, patient-reported pain and function, and overall healing. The results will help determine whether NSAIDs can be used safely as part of pain management after lumbar spinal fusion surgery while potentially reducing the need for opioid medications.
Key facts
- Study ID
- NCT07743606
- Run by
- Rothman Institute Orthopaedics
- People needed
- 428
- Starts
- 2024-07-08
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- ≥18 years of age, ≥1-level planned lumbar spinal fusion
- Capacity to enroll
- English speaking
You may not qualify if…
- 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
Where it is running
- Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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