Clinical study

Safety of ibuprofen after major orthopaedic surgeries – the PERISAFE randomized clinical multicenter trial.

  • Research area: Postoperative pain

  • Primary investigator: Christina Cleveland Westerdahl Laursen

  • Co-primary investigator: Anne Sofie Therkelsen

A large randomized clinical trial investigating the safety with ibuprofen treatment for acute postoperative pain in patients undergoing elective total hip and knee arthroplasty surgeries.

Each day millions of patients are treated with non-steroidal anti-inflammatory drugs (NSAIDs) for acute or chronic pain conditions. Efficient pain treatment for acute postoperative pain is crucial for patient’s well-being and improve their postoperative rehabilitation. Total hip and knee arthroplasties are some of the most frequent planned surgical procedures worldwide, and the numbers are increasing.

Multimodal analgesic treatment is considered the current leading treatment principle for managing acute postoperative pain. NSAIDs are the mainstay of most multimodal analgesic regimens, and apart from their well-known pain relieving abilities, NSAIDs are associated with improved short term postoperative rehabilitation, and their anti-inflammatory effects may be important for other post-surgical outcomes. On the opposite, NSAIDs have been associated with a variety of serious adverse events, including gastrointestinal ulcer, bleeding, kidney impairment and cardiovascular morbidity and mortality.

Overall, there have been a general research focus on efficiency data in pain literature, whereas safety data on adverse effects are short in supply. Basically, we do not know whether effective acute perioperative pain treatment with NSAID protects against complications or if NSAID have significant safety issues. Each day the clinicians are challenged by the question: is NSAID safe for my patients?

The PERISAFE trial will enable us to make the best recommendations whether ibuprofen – the most frequently prescribed NSAID – should be included in the surgical pain treatment or not following elective hip and knee arthroplasties.

The PERISAFE trial will be the first large, randomized trial to assess the risk of serious adverse events of a shorter perioperative analgesic treatment with ibuprofen. The trial will investigate the treatment as close to daily clinical life as possible and we expect the results to have major impact of treatment of hip and knee arthroplasty patients in the future.

Further information about the PERISAFE trial: and