Methadone and Quality of Postoperative Recovery

Conditions

• Quality of Recovery Scores

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Methadone — DRUG
  Methadone will be provided at induction of anesthesia
• Saline — DRUG
  Saline will be administered at induction of anesthesia

Study Details

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.

Key Dates

Start date

Dec 25, 2018

Status verified

Aug 2020

Primary completion

May 25, 2021

Completion

Jul 25, 2021

Study Design

Enrollment

130 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Methadone Group
  Patients in this group will receive 0.4 mg/kg of methadone at induction of anesthesia
• Sham Comparator: Saline-Control Group
  Patients in this group will receive an equal volume of saline as the active comparator group at induction of anesthesia

Primary Outcome Measure

Quality of recovery scores (QoR 40) on postoperative day 1 [ Time Frame: 24 hours ]

Central Contacts

• Glenn S Murphy, MD
  847-570-2760
  [email protected]

Locations (1)

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