Safety of ibuprofen after major orthopaedic surgeries - the PERISAFE randomized clinical multicentre trial
This research study, called PERISAFE, is checking the safety of ibuprofen for people who have had major hip or knee replacement surgery. We want to understand if taking ibuprofen after these operations increases the risk of certain health problems. These could include issues like heart attacks, strokes, blood clots, kidney problems, serious bleeding, or needing another operation or hospital stay within 90 days. Over 90 days, we're comparing a standard ibuprofen dose (400 mg) with a dummy pill in a large group of patients. This helps us ensure that ibuprofen, a common painkiller, is a safe option for managing pain after these important surgeries, ultimately improving patient care.
At a glance
What is this study about?
This study, called PERISAFE, is looking closely at how safe a common painkiller, ibuprofen, is for people who have recently had a major hip or knee replacement operation. Many people take ibuprofen for pain, but we want to make sure it's a good and safe choice for pain relief after big surgeries like these. We're doing this study to find out if ibuprofen might cause any serious health problems in the 90 days after surgery.
The main things we're watching out for are serious events like heart attacks, strokes, blood clots, kidney problems, major bleeding, needing another operation, stomach ulcers, or having to go back to hospital. By comparing people who take ibuprofen with those who take a 'dummy' pill (one with no medicine in it), we can get a clear picture of ibuprofen's safety. This kind of research is really important because it helps doctors make the best decisions about which pain medicines to give patients after surgery to help them recover well and safely.
We also want to understand other things, like how many days people spend out of hospital, if ibuprofen causes any common side effects like stomach upset or reflux, and if other pain medicines (opioids) cause problems like nausea or constipation. We'll also look at how people's quality of life changes after surgery. This detailed information will help us understand the full impact of ibuprofen on people's recovery and overall well-being.
Key takeaways
- The study investigates the safety of ibuprofen after hip or knee replacement surgery.
- It aims to prevent serious adverse events like heart issues, blood clots, or stomach problems.
- Participants will receive either ibuprofen or a dummy pill for pain relief.
- Your health will be monitored for 90 days, with follow-up until one year.
- The findings will help improve pain management for future patients.
- This research focuses on ensuring pain relief is both effective and safe.
Who may be eligible?
To take part in this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.
Specifically, you would be considered if you are having either a hip or a knee replacement surgery. The study is focusing on people recovering from these types of major operations. More detailed eligibility requirements would be discussed with you by the study team.
If you're interested, the study team would check your general health and medical history to make sure taking part is safe and suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you scheduled for a hip replacement surgery?
- Are you scheduled for a knee replacement surgery?
- Are you generally in good health and able to participate in a study?
- Are you willing to complete a daily diary for 8 days after surgery?
- Are you able to attend follow-up assessments for up to one year?
What does participation involve?
If you decide to join this study, you would receive either ibuprofen 400 mg or a matching dummy pill (called a placebo) after your hip or knee replacement surgery. You wouldn't know which one you're taking, and neither would your doctors, to keep the results fair. You would take this medication for a set period. You would also be asked to keep a daily diary for the first eight days after your operation, noting down any pain or side effects you might experience, such as stomach upset or nausea.
The research team will closely monitor your health for 90 days after your surgery to check for any serious health events or if you need to be readmitted to the hospital. You will also complete a questionnaire about your quality of life at 90 days and again one year after your surgery. The full duration of your participation, including follow-up, would be about one year.
Potential risks and benefits
Locations (1)
- —UnverifiedDenmark
Common questions
What kind of surgery is this study for?
This study is for people having major hip or knee replacement surgery.
What is ibuprofen 400 mg?
It's a common painkiller often used to relieve pain and reduce inflammation.
What is a 'dummy pill'?
A 'dummy pill' looks exactly like the medicine but doesn't contain any active drug. It helps compare the real medicine's effects fairly.
Will I know if I'm getting ibuprofen or the dummy pill?
No, you won't know, and neither will your doctors. This is called 'blinding' and helps keep the study unbiased.
How long will I be involved in the study?
You'll be monitored for 90 days, and complete a quality of life questionnaire after 90 days and again at one year after your surgery.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.