Safety of Ibuprofen After Major Orthopaedic Surgeries — PERISAFE  

Postoperative Pain Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

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:

• One-year follow-up on the composite primary outcome.

• Subgroup analysis on predictors of chronic pain and opioid consumption at 90-days, and one-year after surgery.

• Coherence of preoperative use of diuretics, ACE-inhibitors or Angiotensin-II-antagonists and postoperative risk of renal failure. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05575700
• Study type: Interventional
• Source: Naestved Hospital
• Contact: Daniel Hägi-Pedersen, Assoc. Prof
• Phone: +45 21517167
• Email: dhag@regionsjaelland.dk
• Status: Recruiting
• Phase: Phase 4
• Start date: April 17, 2023
• Completion date: December 31, 2026