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

ConditionsPostoperative PainRecovery
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexandre P. Joosten

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Elective intermediate-risk noncardiac surgery under general anesthesia

ASA physical status I-III

Expected hospital stay ≥24 hours

Disqualifiers

Severe hepatic dysfunction (Child-Pugh C)

Severe renal impairment (eGFR <30 mL/min/1.73 m²)

Known allergy to methadone or opioids

Pregnancy or breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravenous Methadone

    Drug

    Intervention Description - Intravenous Methadone A single intravenous dose of methadone (0.25 mg/kg based on ideal body weight) administered at induction of anesthesia to provide sustained intraoperative and early postoperative analgesia. Additional short-acting opioids are discouraged but may be administered if clinically required. A supplemental dose of methadone (2 mg) may be given at emergence in case of significant nociceptive signs.

  • Short-acting Opioids Intraoperative analgesia

    Drug

    ntervention Description - Short-acting Opioids Intraoperative analgesia using short-acting opioids (e.g., fentanyl and/or hydromorphone) administered at induction and throughout surgery according to clinician judgment and institutional practice. This approach reflects usual care, with dosing and timing determined pragmatically based on intraoperative needs.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Experimental Arm: Methadone-Based AnesthesiaExperimental treatment 1 intervention
Group B: Active Comparator Arm: Standard Opioid-Based AnesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality of Recovery (QoR-15) score on postoperative day 1

Quality of recovery assessed using the validated 15-item QoR-15 questionnaire. Scores range from 0 to 150, with higher scores indicating better recovery.

Time frame
Postoperative Day 1 (24 hours after surgery)

Secondary outcomes

1

QoR-15 score on postoperative day 2

Time frame
Time Frame: Postoperative Day 2
2

Cumulative opioid consumption (MME)

Time frame
Time Frame: 0-24 hours and 24-48 hours postoperatively
3

Maximum pain scores (Numeric Rating Scale)

Time frame
Time Frame: Postoperative day 1 and 2
4

Opioid-free days

Time frame
Time Frame: Within 7 days postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandre P. Joosten

Lead sponsor

University of California, Los Angeles

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: