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

29. april 2026 opdateret af: Alexandre P. Joosten

Methadone for Enhanced Postoperative Analgesia in Intermediate-Risk Noncardiac Surgery: A Multicentre Randomized Controlled Trial (MELODY 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Acute postoperative pain remains insufficiently controlled in a substantial proportion of surgical patients, with more than half reporting moderate-to-severe pain after surgery. Standard intraoperative opioid strategies rely on short-acting agents such as fentanyl or hydromorphone, which are associated with rapid clearance and fluctuating plasma concentrations that may contribute to variability in nociceptive control and increased postoperative opioid requirements.

Methadone offers a pharmacologic profile that may address these limitations. It provides prolonged analgesic effect due to its long elimination half-life, rapid effect-site equilibration, and additional N-methyl-D-aspartate receptor antagonism, potentially reducing central sensitization and improving postoperative pain control.

The MELODY trial is a multicentre, patient-blinded, randomized, parallel-group superiority trial conducted across University of California hospitals. Participants are randomized in a 1:1 ratio to receive either intravenous methadone at induction or standard short-acting opioid-based anesthesia.

All patients receive a standardized multimodal analgesic regimen to isolate the effect of the intraoperative opioid strategy. The primary outcome is quality of recovery on postoperative day 1, assessed using the validated Quality of Recovery-15 (QoR-15) questionnaire. Secondary outcomes include opioid consumption, pain scores, opioid-related adverse events, and health-related quality of life.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

400

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria

  • Age ≥18 years
  • Elective intermediate-risk noncardiac surgery under general anesthesia
  • ASA physical status I-III
  • Expected hospital stay ≥24 hours
  • Ability to provide informed consent

Exclusion Criteria

  • 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
  • Chronic opioid use or opioid use disorder
  • Planned use of epidural or regional analgesia
  • Inability to complete study assessments

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental Arm: Methadone-Based Anesthesia

Intervention: Drug: Methadone

Intravenous methadone 0.25 mg/kg (ideal body weight) administered at induction Optional supplemental dose (2 mg) at emergence if clinically indicated Additional intraoperative short-acting opioids discouraged
Medicin: Intravenous Methadone

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.
Aktiv komparator: Active Comparator Arm: Standard Opioid-Based Anesthesia

Intervention: Drug: Short-acting opioids

Fentanyl and/or hydromorphone administered intraoperatively according to clinician judgment Reflects usual care practice
Medicin: Short-acting Opioids Intraoperative analgesia

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of Recovery (QoR-15) score on postoperative day 1
Tidsramme: Postoperative Day 1 (24 hours after surgery)
Quality of recovery assessed using the validated 15-item QoR-15 questionnaire. Scores range from 0 to 150, with higher scores indicating better recovery.
Postoperative Day 1 (24 hours after surgery)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
QoR-15 score on postoperative day 2
Tidsramme: Time Frame: Postoperative Day 2
Time Frame: Postoperative Day 2
Cumulative opioid consumption (MME)
Tidsramme: Time Frame: 0-24 hours and 24-48 hours postoperatively
Time Frame: 0-24 hours and 24-48 hours postoperatively
Maximum pain scores (Numeric Rating Scale)
Tidsramme: Time Frame: Postoperative day 1 and 2
Time Frame: Postoperative day 1 and 2
Opioid-free days
Tidsramme: Time Frame: Within 7 days postoperatively
Time Frame: Within 7 days postoperatively
Opioid-related adverse events
Tidsramme: Time Frame: Up to 48 hours postoperatively
Includes nausea, vomiting, sedation, respiratory depression
Time Frame: Up to 48 hours postoperatively
Health-related quality of life (EQ-5D-5L)
Tidsramme: 30 days post-surgery

The EQ-5D-5L (EuroQol 5-Dimension 5-Level Version) is a health-related quality of life assessment tool that measures quality of life across five dimensions:

Mobility: 1 = No problems, 5 = Extreme problems Self-care: 1 = No problems, 5 = Extreme problems Usual activities: 1 = No problems, 5 = Extreme problems Pain/discomfort: 1 = No problems, 5 = Extreme problems Anxiety/depression: 1 = Not at all, 5 = Extremely severe Each dimension is scored on a 5-level scale, allowing for a detailed assessment of health status.
30 days post-surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alexandre P. Joosten

Efterforskere

  • Studieleder: Joseph Szokol, MD PhD, University of California, Los Angeles
  • Studieleder: EVAN KARASCH, MD PhD, Duke

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

30. marts 2027

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB-25-2394

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

we will decide later

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ja

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produkt fremstillet i og eksporteret fra U.S.A.

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