protocolSection identificationModule nctId: NCT06387303, orgStudyIdInfo id: HSR230492, briefTitle: Pain Control and Quality of Recovery After Intravenous Methadone Versus Intrathecal Morphine in Major Abdominal Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-12, primaryCompletionDateStruct date: 2026-05-11, completionDateStruct date: 2026-05-11, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Virginia, class: OTHER, descriptionModule briefSummary: Moderate to severe postoperative pain is relatively common after major abdominal surgery and is associated with less than optimal surgical experience, poor quality of recovery, and development of persistent postsurgical pain. Opioids remain a major component of postoperative pain management. Side effects of opioids used for treatment of postoperative pain include constipation, pruritus, nausea, and vomiting.1,2 Enhanced recovery after surgery (ERAS) protocols involve utilization of multimodal analgesia. Analgesic techniques used include epidural analgesia, nerve blocks, and Intrathecal (IT) administration of morphine. IT morphine reduces postoperative opioid requirement for 18-24 hours after major abdominal surgery and reduces hospital length of stay (LOS) compared with epidural analgesia.3,4 Significant number of patients that receive IT morphine still experience moderate to severe postoperative pain.5 Additionally, many patients refuse the invasive procedure or cannot receive IT morphine due to procedure contraindications; thrombocytopenia and/or coagulopathy.6Intravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties.7-9 It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients that underwent orthopedic, abdominal, complex spine, and cardiac surgery.10-13 Similar findings have been shown in obstetric patients that underwent caesarean delivery under general anesthesia as well as patients that underwent gynecologic surgery.14,15 IV methadone has, however, never been compared with IT morphine as a postoperative analgesic.Our hypothesis is that intravenous (IV) methadone is non-inferior to IT morphine in patients who undergo major abdominal surgery. It offers the advantage of being a noninvasive analgesic, modality that may contribute to decreasing opioid consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving quality of recovery after surgery., conditionsModule conditions: Pain, Postoperative, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: a single blind study, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 218, type: ESTIMATED, armsInterventionsModule interventions name: Methadone, interventions name: Morphine, outcomesModule primaryOutcomes measure: Quality of Recovery 15 score, primaryOutcomes measure: Overall Benefits of Analgesic Score (OBAS), primaryOutcomes measure: morphine milligram equivalent, primaryOutcomes measure: Verbal Rating Scale (VRS) pain scores, secondaryOutcomes measure: McGill Pain questionnaire score, secondaryOutcomes measure: Verbal Rating Scale (VRS) pain scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Virginia, city: Charlottesville, state: Virginia, zip: 22908-0710, country: United States, geoPoint lat: 38.02931, lon: -78.47668, hasResults: False