drugset / Trial / NCT07565870

Methadone for Enhanced Postoperative Analgesia in Intermediate-Risk Noncardiac Surgery (MELODY)

NCT07565870

Phase 3 Not yet recruiting 400 enrolled Alexandre P. Joosten
RandomizedParallel-groupSingle-blindTreatment

Summary

Postoperative pain control remains suboptimal for a large proportion of surgical patients and is frequently associated with slower recovery and higher reliance on opioids after surgery. Current intraoperative analgesic approaches predominantly use short-acting opioids, whose rapid pharmacokinetics can lead to variable drug exposure and inconsistent control of nociceptive stimuli. Methadone has a different pharmacologic profile, combining prolonged μ-opioid receptor activity with N-methyl-D-aspartate receptor antagonism, allowing sustained analgesia following a single intraoperative administration and potentially enhancing postoperative recovery. The MELODY trial is a multicentre, randomized, patient-blinded clinical study designed to compare a single intravenous dose of methadone given at induction with conventional short-acting opioid-based anesthesia in adults undergoing intermediate-risk noncardiac surgery. The primary aim is to evaluate whether this strategy leads to improved quality of recovery on the first postoperative day.

Timeline

Start
2026-07-01
Primary completion
2026-12-31
Completion
2027-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Methadone Other / unclassified 0.25 mg/kg Intravenous
Comparator Fentanyl Other / unclassified
Comparator Hydromorphone Other / unclassified

Indications

No indication recorded.