The Adverse Effects Associated With Ibuprofen Use After Major Orthopaedic Surgeries-A Detailed Statistical Analysis...

Area of Science:

• Orthopedic Surgery
• Pharmacology
• Clinical Trials

Background:

• Postoperative pain management after hip and knee arthroplasty often involves non-steroidal anti-inflammatory drugs (NSAIDs).
• Ibuprofen is commonly used, but its safety profile, particularly concerning major adverse events, requires thorough investigation in this patient population.

Purpose of the Study:

• To assess the safety and adverse effects of an 8-day postoperative ibuprofen treatment following hip and knee arthroplasties.
• To outline the detailed statistical analysis plan for the PERISAFE trial's primary data.

Main Methods:

• A randomized, placebo-controlled, blinded multicentre trial involving 2904 patients undergoing hip or knee arthroplasty.
• Patients received either ibuprofen (400 mg three times daily) or placebo for 8 days postoperatively.
• The primary outcome is a composite of major adverse events within 90 days, including death, cardiovascular events, bleeding, and re-operation.

Main Results:

• The statistical analysis plan details methods for primary and secondary outcomes, including mixed-effects models and the win ratio calculation.
• An interim analysis will be performed after 1400 patients are included.
• All analyses will be adjusted for the multicentre nature of the trial.

Conclusions:

• The PERISAFE trial is designed to provide high-quality data on the safety of postoperative ibuprofen use after elective hip and knee arthroplasty.
• The predefined methodology ensures robust evaluation of potential adverse effects.