Clinical trial

Safety of Ibuprofen After Major Orthopaedic Surgeries. The PERISAFE Randomized Clinical Multicentre Trial

NCT05575700

Name

001CCWL2022

Description

Safety of an eight-day treatment with ibuprofen after primary hip and knee arthroplasties.

Trial arms

Trial start

2023-04-17

Estimated PCD

2025-07-01

Trial end

2026-12-31

Status

Recruiting

Phase

Early phase I

Treatment

Ibuprofen

400 mg tablet three times daily

Arms:

Ibuprofen

Placebo

tablet three times daily

Arms:

Placebo

Size

2904

Primary endpoint

A composite outcome 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.

Postoperative day 0 to 90.

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': "The study medication will be masked by the pharmacy. The experimental medicine will be packed and labelled by Region Hovedstadens Pharmacy in accordance with the Good Manufacturing Practice regulations. The sponsor has a set of sealed, opaque envelopes with the participants' allocation, and these will only be revealed for the investigators when the data has been analysed and abstracts and conclusions covering the different possibilities for interpreting the trial results, have been agreed upon by the steering committee", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2904, 'type': 'ESTIMATED'}}

Updated at

2023-04-28

1 organization

1 product

1 drug

9 indications

Organization

Naestved Hospital

Product

Ibuprofen

Indication

Pain