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NSAID (Non-Steroidal Anti-Inflammatory Drug)PainDrugPhase 3

What this study is

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.

What's being tested

  • Ketorolac

    Intervention · DRUG

    Intravenous ketorolac 15 mg administered every 6 hours for up to 48 hours after surgery.

  • Naproxen

    Intervention · DRUG

    Oral naproxen 500 mg administered twice daily for 7 days after hospital discharge.

  • Standard Postoperative Pain Management

    Intervention · OTHER

    Standard postoperative multimodal pain regimen used at the institution, excluding NSAIDs administered as part of the study intervention.

Study details

Official title
Randomized Controlled Trial of Postoperative Inpatient Ketorolac and Outpatient Naproxen Use Following Elective Lumbar Spine Fusion
Sponsor
Rothman Institute Orthopaedics
Conditions
NSAID (Non-Steroidal Anti-Inflammatory Drug) · Lumbar Spine Fusion · Ketorolac · Postoperative Pain
Enrolling
428 people
Starts
2024-07-08
Est. completion
2028-12-31
Design
Single-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗