Actively Recruiting
Methadone and Quality of Postoperative Recovery
Led by Endeavor Health · Updated on 2020-08-24
130
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Methadone and Quality of Postoperative Recovery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for elective cardiac surgery with cardiopulmonary bypass
You will not qualify if you...
- 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 requiring home oxygen therapy
- Need for inotropic agents or intraaortic balloon pump before surgery to maintain hemodynamic stability
- Allergy to methadone or fentanyl
- Significant preoperative pain requiring opioid treatment or recent opioid abuse
- Inability to speak or read English or neurologic conditions affecting ability to complete the QoR-40 questionnaire
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Actively Recruiting
Research Team
G
Glenn S Murphy, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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