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Safety of Ibuprofen After Major Orthopaedic Surgeries

NCT ID: NCT05575700

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2904 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-17

Study Completion Date

2025-08-19

Brief Summary

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

Detailed Description

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Hip and knee arthroplasty surgeries are some of the most frequently performed planned procedures in the western world. Multimodal analgesic treatment is the leading analgesic treatment principle, with NSAIDs as an essential part. Ibuprofen, the most frequently prescribed NSAID, is effective in reducing acute postoperative pain. However, ibuprofen may be associated with various serious adverse events, including death, cardiovascular morbidity, gastrointestinal ulcer, and renal impairment. The balance between beneficial and harmful effects of a short-term postoperative treatment with ibuprofen after elective hip and knee arthroplasty is unknown.

Objectives: to assess the adverse events of an eight-day treatment of postoperative pain with ibuprofen in patients undergoing elective primary hip or knee arthroplasty.

Intervention: the participants will be randomized in two groups: a) oral ibuprofen 400 mg 3 times daily for eight days. b) identical oral placebo 3 times daily for eight days.

Design and trial size: PERISAFE is a randomized, placebo-controlled multicentre trial with centralized computer-generated allocation sequence and allocation concealment with unknown block size. Patients, investigators, assessors, caregivers, data-managers, writers of the manuscript, and statisticians will be blinded. A total of 2904 eligible patients are needed to detect or discard an effect corresponding to a relative risk reduction of 1/3 with an acceptable risk of type I error of 5 % and of type II error of 20 %, and a proportion of the composite outcome of serious adverse events of 8% in the experimental group.

Sub-studies:

* Serious adverse events relating to the renal system
* Serious adverse events relating to the cardiovascular system
* Serious adverse events relating to the gastrointestinal system, including major bleeding
* Persistent pain and opioid consumption at 90 days and one year postoperatively. Predictive co-factors include preoperative analgesic treatment, type of anesthesia, gender, age, ASA-classification, diabetes, and type of surgery
* Bayesian re-analysis of the primary and secondary outcomes up to 90 days postoperatively. Further details will appear in the statistical analysis plan
* Health-related quality of life via EQ-5D-5L questionnaire 90-days and one year postoperatively

Conditions

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Safety Issues Analgesia Analgesic Adverse Reaction Postoperative Pain Postoperative Complications Knee Arthropathy Pain, Acute Hip Arthropathy

Keywords

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PERISAFE Hip Arthroplasty Knee Arthroplasty Postoperative pain Analgesia Safety Non-steroidal Anti-inflammatory drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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

Study Groups

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Ibuprofen

Participants received ibuprofen 400 mg tablet administered orally three times daily, with eight hour intervals, for eight days after surgery.

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

400 mg tablet three times daily

Placebo

Participants received identical placebo tablet administered orally three times daily, with eight hour intervals, for eight days after surgery.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

tablet three times daily

Interventions

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Ibuprofen

400 mg tablet three times daily

Intervention Type DRUG

Placebo

tablet three times daily

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Naestved Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ole Mathiesen, Professor

Role: STUDY_CHAIR

Zealand University Hospital

Locations

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Private Hospital Gildhøj

Brøndby, , Denmark

Site Status

Bispebjerg Hospital

Copenhagen NV, , Denmark

Site Status

Aalborg University Hospital

Farsø, , Denmark

Site Status

Gentofte Hospital

Hellerup, , Denmark

Site Status

Nordsjællands Hospital Hillerød

Hillerød, , Denmark

Site Status

Zealand University Hospital

Køge, , Denmark

Site Status

Næstved Hospital

Næstved, , Denmark

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Silkeborg Regional Hospital

Silkeborg, , Denmark

Site Status

Svendborg Hospital

Svendborg, , Denmark

Site Status

Vejle Sygehus

Vejle, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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001CCWL2022

Identifier Type: -

Identifier Source: org_study_id