Phase 4
N=164
The Effect of Choice of Intraoperative Opioid on Postoperative Pain
Pain, Postoperative · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT01542645 ↗Enrolled (actual)
164
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Total Opioid Consumption in the Postoperative Period — 8; 14 milligrams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methadone (Drug); Fentanyl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endeavor Health
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Consumption in the Postoperative Period |
8; 14 | — |
| SECONDARY Postoperative Pain Scores |
3; 4.5 | — |
| SECONDARY Chronic Postoperative Pain Scores-Weekly Frequency of Pain |
0; 2 | — |
| SECONDARY Marker of Myocardial Injury (Troponin I) |
5.4; 4.6 | — |
| SECONDARY 3 Months-Chronic Pain-weekly Frequency of Pain |
0; 0.5 | — |
| SECONDARY 6 Months-Chronic Pain-weekly Frequency of Pain |
0; 0 | — |
| SECONDARY 12 Months-Chronic Pain-weekly Frequency of Pain |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- All patients presenting for elective cardiac surgery with CPB will be eligible for enrollment.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01542645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.