Non-steroidal Anti-inflammatory in Cardiac Surgery

Phase 3

Recruiting

• Conditions: Non-steroidal Anti-inflammatory Drugs; Cardiac Surgery; Multimodal Pain Management; Pain Intensity; Acute Postoperative Pain
• Interventions: Drug: pain management; Drug: PLacebo; Drug: ketoprofen

• Registration Number: NCT06381063
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Non-steroidal anti-inflammatory drugs (NSAID) are part the multimodal strategy in pain management after surgery. However, major concerns are raised in cardiac surgery given the potential side effects of NSAID with more bleeding and acute kidney injury. The investigators hypothesized that NSAID are safe in the early postoperative course after cardiac surgery with respect to contraindication.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-27
• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Primary Completion: 2027-03
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

• scheduled for cardiac surgery (aortic valve replacement, coronary artery bypass graft, mitral valve repair or replacement, intracardiac tumor, aortic root repair)
• under cardiopulmonary bypass
• Affiliation to the French national healthcare system
• Written consent obtained

Exclusion Criteria

• age<18
• weight<50 kg
• chronic use of NSAID
• mini-invasive surgery
• NSAID contraindication
• NSAID allergy
• Nefopam contraindication
• Paracetamol contraindication
• Tramadol contraindication
• Urgent surgery
• Endocarditis
• Immunosuppressive drug
• HIV infection with CD4<200 mm3
• Organ transplantation
• Stage 4 or 5 chronic kidney disease
• Gastro duodenal ulcer
• Pregnancy
• Depression
• Auto immune disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	PLacebo	Placebo twice a day, during 48 h after surgery, intravenous administration
Ketoprofen	pain management	Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration
Placebo	pain management	Placebo twice a day, during 48 h after surgery, intravenous administration
Ketoprofen	ketoprofen	Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration

Primary Outcome Measures

Name	Time	Method
NSAIDs reduce postoperative at rest at 24 hours from the end of surgery	at 24 hours	Pain intensity will be assessed at rest at 24 hours from the end surgery using the numerous rating scale (NRS) graded from 1 (no pain) to 10 (high pain intensity)
reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery	at 24 hours	Pain intensity will be assessed using the NRS at 24 hours from the end of surgery during chest physiotherapy

Secondary Outcome Measures

Name	Time	Method
Change in pain trajectory during the first 7 days after cardiac surgery	7 days	Pain trajectory will be assessed every day using NRS and trajectory will be defined as following
Change in cumulative opioid within 48 hours after surgery	48 hours	Total dose of oxynorm or morphine will be recorded from the end of surgery to 48 h after and expressed in milligram
Change in pulmonary postoperative complications within 7 days after surgery	7 days	Postoperative pulmonary complications will be defined by the occurrence of at least one item among following: atelectasis, pneumonia, acute respiratory distress syndrome, acute respiratory failure, bronchospasm

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, France