Methadone and Quality of Postoperative Recovery

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorEndeavor Health

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Methadone

    Drug

    Methadone will be provided at induction of anesthesia

  • Saline

    Drug

    Saline will be administered at induction of anesthesia

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Methadone GroupActive comparator 1 intervention
Group B: Saline-Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality of recovery scores (QoR 40) on postoperative day 1

The QoR 40 scoring system will be used to assess postoperative quality of recovery

Time frame
24 hours

Secondary outcomes

1

Quality of recovery scores (QoR 40) on postoperative day 2

The QoR 40 scoring system will be used to assess postoperative quality of recovery

Time frame
48 hours
2

Quality of recovery scores (QoR 40) on postoperative day 3

The QoR 40 scoring system will be used to assess postoperative quality of recovery

Time frame
72 hours
3

Pain scores on on postoperative day 1

Assessment of pain on 11-point verbal analogue scale (0=no pain, 10=worst pain imaginable)

Time frame
24 hours
4

Pain scores on on postoperative day 1

Assessment of pain on 11-point verbal analogue scale (0=no pain, 10=worst pain imaginable)

Time frame
48 hours

Other outcomes

Sponsors and contacts

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