Evaluating the safety of ibuprofen after hip and knee surgeries
Safety of Ibuprofen After Major Orthopaedic Surgeries. The PERISAFE Randomized Clinical Multicentre Trial
This study is testing whether taking ibuprofen for eight days after hip and knee surgeries is safe for patients and how it compares to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 2904 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Naestved Hospital Academic / other |
| Locations | 11 sites (Brøndby and 10 other locations) |
| Trial ID | NCT05575700 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety of an eight-day treatment with ibuprofen for postoperative pain management in patients undergoing elective primary hip and knee arthroplasties. Participants will be randomly assigned to receive either ibuprofen or a placebo, with both groups monitored for adverse events. The study aims to determine the balance between the benefits of pain relief and the potential risks associated with ibuprofen use in this context. A total of 2904 patients will be enrolled to ensure robust results.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older scheduled for elective primary hip or knee arthroplasty.
Not a fit: Patients with allergies to ibuprofen or contraindications against its use will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safe use of ibuprofen for pain management after major orthopedic surgeries.
How similar studies have performed: Previous studies have explored the use of NSAIDs for postoperative pain management, but this specific investigation into the safety of ibuprofen after hip and knee arthroplasties is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for elective primary hip and knee arthroplasty. * Age ≥ 18 years. * Planned postoperative treatment with NSAID. * Negative pregnancy test for women in the fertile age. * Informed consent. Exclusion Criteria: * Unable to understand or speak Danish. * Allergy to or contraindications against ibuprofen.
Where this trial is running
Brøndby and 10 other locations
- Private Hospital Gildhøj — Brøndby, Denmark (Not_yet_recruiting)
- Bispebjerg Hospital — Copenhagen NV, Denmark (Not_yet_recruiting)
- Aalborg University Hospital — Farsø, Denmark (Not_yet_recruiting)
- Gentofte Hospital — Hellerup, Denmark (Recruiting)
- Nordsjællands Hospital Hillerød — Hillerød, Denmark (Not_yet_recruiting)
- Zealand University Hospital — Køge, Denmark (Not_yet_recruiting)
- Næstved Hospital — Næstved, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Not_yet_recruiting)
- Silkeborg Regional Hospital — Silkeborg, Denmark (Not_yet_recruiting)
- Svendborg Hospital — Svendborg, Denmark (Not_yet_recruiting)
- Vejle Sygehus — Vejle, Denmark (Not_yet_recruiting)
Study contacts
- Study coordinator: Daniel Hägi-Pedersen, Assoc. Prof
- Email: dhag@regionsjaelland.dk
- Phone: +45 21517167
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.