Clinical Trial

Methadone and Quality of Postoperative Recovery

Recruiting Phase 4
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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.
Summary
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2017-05-25; most recent amendment 2023-06-13.
Status change: Recruiting → Terminated 2023-06-13
Trial Details
NCT Number NCT03168958
Lead Sponsor Endeavor Health
Conditions Quality of Recovery Scores
Enrollment 130 participants
Start Date 2018-12-25
Primary Completion 2021-05-25 (estimated)
Study Completion 2021-07-25 (estimated)
Updated on ClinicalTrials.gov 2020-08-24