Methadone and Quality of Postoperative Recovery

• Status: Recruiting
• Trial end date: 2021-07-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NorthShore University HealthSystem; NorthShore University HealthSystem Research Institute
• Treatments: Anesthetics; Methadone

Criteria

Inclusion Criteria:

• All patients presenting for elective cardiac surgery with CPB will be eligible for enrollment

Exclusion Criteria:

• Preoperative renal failure requiring dialysis or severe renal dysfunction (serum creatinine > 2.0 mg/dL)

• Significant hepatic dysfunction (liver function tests > 2 times upper normal limit)

• Pulmonary disease necessitating home oxygen therapy

• Preoperative requirement for inotropic agents or intraaortic balloon pump to maintain hemodynamic stability

• Allergy to methadone or fentanyl

• Significant preoperative pain requiring treatment with opioids or recent history of opioid abuse

• Inability to speak or read the English language or neurologic conditions that may impair the ability to complete the QoR 40 questionnaire.