The Effect of Choice of Intraoperative Opioid on Postoperative Pain

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NorthShore University HealthSystem; NorthShore University HealthSystem Research Institute
• Treatments: Analgesics, Opioid; Fentanyl; Methadone

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Preoperative renal failure requiring dialysis

2. Significant hepatic dysfunction (liver function tests > 2 times upper normal limit)

3. Preoperative ejection fraction < 30%

4. Pulmonary disease necessitating home oxygen therapy

5. Preoperative requirement for inotropic agents or intraaortic balloon pump to maintain hemodynamic stability

6. Allergy to methadone or fentanyl

7. Preoperative pain, use of preoperative opioids, or recent history of opioid abuse