About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients presenting for elective cardiac surgery with CPB will be eligible for enrollment
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Methadone
DrugMethadone will be provided at induction of anesthesia
Saline
DrugSaline will be administered at induction of anesthesia
Treatment groups
Trial outcomes
Primary outcomes
Quality of recovery scores (QoR 40) on postoperative day 1
The QoR 40 scoring system will be used to assess postoperative quality of recovery
Secondary outcomes
Quality of recovery scores (QoR 40) on postoperative day 2
The QoR 40 scoring system will be used to assess postoperative quality of recovery
Quality of recovery scores (QoR 40) on postoperative day 3
The QoR 40 scoring system will be used to assess postoperative quality of recovery
Pain scores on on postoperative day 1
Assessment of pain on 11-point verbal analogue scale (0=no pain, 10=worst pain imaginable)
Pain scores on on postoperative day 1
Assessment of pain on 11-point verbal analogue scale (0=no pain, 10=worst pain imaginable)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.