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Effect of nonsteroidal anti-inflammatory drugs in the management of postoperative pain after cardiac surgery: A multicentre, randomised, placebo-controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506299-28-00
Enrollment
238
Registered
2024-03-27
Start date
2024-12-02
Completion date
Unknown
Last updated
2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain after cardiac surgery

Brief summary

Postoperative pain at rest will be assessed at 24 hours using a numerical rating scale (NRS) graded from 0 to 10

Detailed description

During chest physiotherapy, postoperative pain will be assessed as for the primary endpoint using the NRS, Postoperative pain every day from the 1st to the 7th day between 8 a.m. and 12 p.m. as for the primary endpoint using the EN and the pain trajectory will be assessed taking into account the NRS between day 3 and day 7, Nausea will be recorded according to a verbal scale (none, moderate, severe), postoperative pulmonary complications will be looked for in the first 7 days after surgery according to the European consensus definitions, Chronic pain will be assessed at 48 hours and at 3 months by completing a concise pain questionnaire using the DN4 scale, Neuropathic pain will be assessed at 48 hours, Quality of life at 3 months will be assessed by the quality of life scale of the EQ-5D-5L questionnaire compared to the assessment the day before surgery

Interventions

DRUGNEFOPAM
DRUGKETOPROFEN
DRUGTRAMADOL
DRUGPARACETAMOL
DRUGSODIUM CHLORIDE

Sponsors

Centre Hospitalier Universitaire Amiens Picardie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Postoperative pain at rest will be assessed at 24 hours using a numerical rating scale (NRS) graded from 0 to 10

Secondary

MeasureTime frame
During chest physiotherapy, postoperative pain will be assessed as for the primary endpoint using the NRS, Postoperative pain every day from the 1st to the 7th day between 8 a.m. and 12 p.m. as for the primary endpoint using the EN and the pain trajectory will be assessed taking into account the NRS between day 3 and day 7, Nausea will be recorded according to a verbal scale (none, moderate, severe), postoperative pulmonary complications will be looked for in the first 7 days after surgery according to the European consensus definitions, Chronic pain will be assessed at 48 hours and at 3 months by completing a concise pain questionnaire using the DN4 scale, Neuropathic pain will be assessed at 48 hours, Quality of life at 3 months will be assessed by the quality of life scale of the EQ-5D-5L questionnaire compared to the assessment the day before surgery

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026