The Effect of Choice of Intraoperative Opioid on Postoperative Pain

Completed · Phase 4

Conditions studied: Pain, Postoperative, Chronic Pain

In brief

The primary aim of this randomized, double-blind study is to examine the effect of a single intraoperative dose of methadone on postoperative pain and analgesic requirements in patients undergoing cardiac surgery with cardiopulmonary bypass. These patients will be compared to subjects receiving a standard dose of the "traditional" intraoperative opioid (fentanyl). Secondary outcome measures to be assessed will include standard recovery variables (such as length of postoperative intubation, ICU length of stay, incidence of nausea or vomiting, level of sedation). In addition, patients will be assessed for the development of chronic postoperative pain.

Key facts

Study ID

NCT01542645

Run by

Endeavor Health

People needed

164

Starts

2010-09-01

Expected to finish

2014-09-01

Last updated by the study team

2019-09-30

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients presenting for elective cardiac surgery with CPB will be eligible for enrollment.

You may not qualify if…

• Preoperative renal failure requiring dialysis
• Significant hepatic dysfunction (liver function tests > 2 times upper normal limit)
• Preoperative ejection fraction < 30%
• Pulmonary disease necessitating home oxygen therapy
• Preoperative requirement for inotropic agents or intraaortic balloon pump to maintain hemodynamic stability
• Allergy to methadone or fentanyl
• Preoperative pain, use of preoperative opioids, or recent history of opioid abuse

Where it is running

• NorthShore University HealthSystem — Evanston, Illinois, United States

Full record on ClinicalTrials.gov

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