Clinical Trial

Intraoperative Methadone for the Prevention of Postoperative Pain

Recruiting Phase 3
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Record status
This record was last updated February 7, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The pain felt after orthopedic surgery in the absence of adequate locoregional anesthesia is often insufficiently controlled, especially during the first 24 hours postoperatively. Methadone, due to its long half-life, may provide better pain control after orthopedic surgery when associated locoregional anesthesia cannot be performed. It may be impossible to perform loco-regional anesthesia in various contexts: patient refusal, pre-existing neurological impairment, infection at the injection site, coagulopathies, inability to cooperate, total language barrier, allergy to anesthetics, unavailability of equipment (ultrasound, etc.) or equipped room, lack of experience of nursing staff in performing the block and in the postoperative management of the patient. Intraoperative administration of methadone in these settings may be superior to sufentanil for pain control during the 24 hours post orthopedic surgery, and the pain control provided by methadone does not appear to imply a higher likelihood of adverse events related to opioids.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-04-25; most recent amendment 2025-02-05.
Trial Details
NCT Number NCT05831345
Lead Sponsor Brugmann University Hospital
Conditions Orthopedic Surgery
Enrollment 80 participants
Start Date 2023-02-28
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-02-07