Recruiting

Methadone

Sponsor:

Endeavor Health

Code:

NCT03168958

Conditions

Quality of Recovery Scores

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Methadone

Saline

Study Details

Brief 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.

Conditions

Quality of Recovery Scores

Study ID

NCT03168958

Start date

Dec 25, 2018

Status verified date

Aug, 2020

Completion date

Jul 25, 2021

Anticipated

Primary completion date

May 25, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Methadone

Methadone will be provided at induction of anesthesia

Saline

Saline will be administered at induction of anesthesia

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

NorthShore University HealthSystem

Recruiting

Evanston, Illinois, United States, 60201

Contacts

More Information

Sponsor

Endeavor Health

Last update posted

Aug 24, 2020

Last verified

Aug, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2020-08-24.