Acta anaesthesiologica Scandinavica · 2025
The adverse effects with ibuprofen after major orthopedic surgeries: A protocol for the PERISAFE randomized clinical trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Laursen Christina Cleveland Westerdahl, Lunn Troels Haxholdt, Hägi-Pedersen Daniel, Therkelsen Anne Sofie Nautrup, Varnum Claus, Lange Kai Henrik Wiborg, Yilmaz Müjgan, Pedersen Niels Anker, Kappel Andreas, Jakobsen Thomas, Eljaja Salamah Belal, Thougaard Thomas, Graungaard Ben Kristian, Bjerno Thomas, Beck Jacob, Runge Charlotte, Steiness Joakim, Gasbjerg Kasper Smidt, Thybo Kasper Højgaard, Brorson Stig, Lindberg-Larsen Martin, Overgaard Søren, Jakobsen Janus Christian, Mathiesen Ole
Аннотация
INTRODUCTION: Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended for pain treatment after elective hip and knee arthroplasties. However, evidence regarding the incidence of adverse effects with short-term NSAID treatment following surgery is limited. We, therefore, aim to assess the adverse effects with an eight-day postoperative treatment with ibuprofen after elective hip and knee arthroplasties.
METHODS AND ANALYSIS: PERISAFE is a randomized, placebo-controlled, blinded multicenter trial with 90-day and one-year follow-up. Eligible patients undergoing elective hip or knee arthroplasty are allocated 1:1 to either ibuprofen 400 mg ×3/day or identical placebo ×3/day for eight days after surgery. The primary outcome is a composite of either death, acute myocardial infarction, stroke, pulmonary embolism, deep venous thrombosis, renal failure, major bleeding, re-operation, gastrointestinal ulcer, or readmission within 90 days postoperatively. Secondary outcomes are hospital-free days within 90 days postoperatively, a composite of ibuprofen and opioid-related adverse reactions based on eight-day postoperative diary, and health related quality of life after 90 days postoperatively. A total of 2904 patients are needed to demonstrate a relative risk reduction of 33% in the placebo group, accepting a risk of type I error of 5% and type II error of 20% and a proportion of serious adverse events in the ibuprofen group of 8%. The primary analysis will be in the modified intention-to-treat population.
ETHICS AND DISSEMINATION: The trial is approved by the Danish Medicine Agency and the Research Ethics Committee (EU CT no. 2022-502, 502-32-00). We plan to submit for publication in a major international peer-reviewed journal and present results at scientific meetings.
METHODS AND ANALYSIS: PERISAFE is a randomized, placebo-controlled, blinded multicenter trial with 90-day and one-year follow-up. Eligible patients undergoing elective hip or knee arthroplasty are allocated 1:1 to either ibuprofen 400 mg ×3/day or identical placebo ×3/day for eight days after surgery. The primary outcome is a composite of either death, acute myocardial infarction, stroke, pulmonary embolism, deep venous thrombosis, renal failure, major bleeding, re-operation, gastrointestinal ulcer, or readmission within 90 days postoperatively. Secondary outcomes are hospital-free days within 90 days postoperatively, a composite of ibuprofen and opioid-related adverse reactions based on eight-day postoperative diary, and health related quality of life after 90 days postoperatively. A total of 2904 patients are needed to demonstrate a relative risk reduction of 33% in the placebo group, accepting a risk of type I error of 5% and type II error of 20% and a proportion of serious adverse events in the ibuprofen group of 8%. The primary analysis will be in the modified intention-to-treat population.
ETHICS AND DISSEMINATION: The trial is approved by the Danish Medicine Agency and the Research Ethics Committee (EU CT no. 2022-502, 502-32-00). We plan to submit for publication in a major international peer-reviewed journal and present results at scientific meetings.