Perioperative medicine & outcomes
The Adverse Effects Associated With Ibuprofen Use After Major Orthopaedic Surgeries—A Detailed Statistical Analysis Plan for the PERISAFE Randomized Clinical Trial
Study context
- Population
- Hip- or knee-arthroplasty patientsplanned
- Participants
- 2,904 participants
- Planned comparison
- Ibuprofen vs Placebo
- Primary endpoint
- Composite of:
- Death
- Acute MI
- Stroke
- PE
- DVT
- Renal failure
- Major bleeding
- Re-operation
- Gastrointestinal ulcer
- Readmission
- Follow-up
- Within 90 days postoperatively
Methodological detailsplacebo-controlled, blinded, multicentre, 1:1 allocation, one interim analysis after 1400 patients, Win ratio calculated for the primary outcome, All randomised patients who undergo surgery included in all analyses, Binary data: mixed-effects generalized linear model; count data: van Elteren test; continuous data: mixed-effects linear regression; all adjusted for site, Secondary outcomes: hospital-free days within 90 days, composite of ibuprofen and opioid-related adverse reactions (8-day diary), health-related quality of life after 90 days
- Placebo-controlled
- Blinded
- Multicentre
- 1:1 allocation
- One interim analysis after 1400 patients
- Win ratio calculated for the primary outcome
- All randomised patients who undergo surgery included in all analyses
- Binary data: mixed-effects generalized linear model; count data: van Elteren test; continuous data: mixed-effects linear regression; all adjusted for site
- Secondary outcomes: hospital-free days within 90 days, composite of ibuprofen and opioid-related adverse reactions (8-day diary), health-related quality of life after 90 days
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
The Adverse Effects Associated With Ibuprofen Use After Major Orthopaedic Surgeries—A Detailed Statistical Analysis Plan for the PERISAFE Randomized Clinical Trial. Acta Anaesthesiol Scand. Published 28 May 2025. doi:10.
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