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Methadone and Quality of Postoperative Recovery

StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated August 24, 2020 (before its estimated May 25, 2021 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: May 25, 2020 to May 25, 2021
    • Study completion date: Jul 25, 2020 to Jul 25, 2021
    v6
  2. Notable Start date: May 25, 2017 to Dec 25, 2018v5
  3. Notable Primary completion date: May 25, 2019 to May 25, 2020
    • Study completion date: Jul 25, 2019 to Jul 25, 2020
    v4
  4. Minor Re-verified, no change to tracked fieldsv3
  5. Minor Eligibility criteria revised
    • Secondary endpoints revised (8)
    • Study description expanded, about 4 words
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Patients undergoing cardiac surgery often experience moderate to severe pain in the early postoperative period. A number of methods have been used to help control pain after surgery; however, each of these techniques adds additional costs and risks. A simple and effective way to decrease this pain is to administer a long-acting opioid in the operating room. Methadone is a opioid that can produce analgesia (pain relief) that lasts up to 48 hours when given in large doses (0.3 to 0.4 mg/kg). Previous studies have demonstrated that both pain and requirements for analgesic medications are significantly reduced for up to three days after surgery if methadone is given at induction (the start) of anesthesia. In the study that was performed at Evanston Hospital, cardiac surgical patients who were given methadone also appeared to "feel better" after surgery compared to those given a standard or typical intraoperative opioid. The aim of this randomized clinical trial is to determine whether overall quality of postoperative recovery can be enhanced if methadone is given in the operating room. Quality of recovery will be determined by using a validated scoring system, the QoR 40, which will be given to patients to complete on the first three days after surgery.
Trial Details
NCT Number NCT03168958
Lead Sponsor Endeavor Health
Conditions
(from sponsor)
Quality of Recovery Scores
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov