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Methadone and Quality of Postoperative Recovery

NCT03168958 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2020-08-24

No results posted yet for this study

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

Interventions

DRUG

Methadone

Methadone will be provided at induction of anesthesia

DRUG

Saline

Saline will be administered at induction of anesthesia

Sponsors & Collaborators

  • Endeavor Health

    lead OTHER

Principal Investigators

  • Glenn S Murphy, MD · Endeavor Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-25
Primary Completion
2021-05-25
Completion
2021-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03168958 on ClinicalTrials.gov