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Enrolling By Invitation NCT07743606

NSAIDS Following Elective Lumbar Spine Fusion

Conditions: NSAID (Non-Steroidal Anti-Inflammatory Drug), Lumbar Spine Fusion, Ketorolac, Postoperative Pain

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 428
Sponsor: Rothman Institute Orthopaedics

Location: Rothman Orthopaedic Institute Philadelphia Pennsylvania

Summary

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.

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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07743606). StuddyBuddy aggregates publicly available trial information.