Chronic Pain Clinical Trial
Official title:
The Effect of Choice of Intraoperative Opioid on Postoperative Pain
Verified date | September 2019 |
Source | NorthShore University HealthSystem |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 164 |
Est. completion date | September 2014 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | NorthShore University HealthSystem | Evanston | Illinois |
Lead Sponsor | Collaborator |
---|---|
NorthShore University HealthSystem |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Opioid Consumption in the Postoperative Period | Total intravenous morphine used first three days (72 hours after ICU admission) | First 3 days after surgery | |
Secondary | Postoperative Pain Scores | Pain was assessed on a 11-point verbal analogue scale with 0=no pain, 10=worst pain imaginable | 2 hours after cardiac surgery | |
Secondary | Chronic Postoperative Pain Scores-Weekly Frequency of Pain | 0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant | 1 months after surgery | |
Secondary | Marker of Myocardial Injury (Troponin I) | In a cohort of patients undergoing only coronary artery bypass graft surgery (n=75), serum troponins will be measured postoperatively to determine whether methadone has a potential cardioprotective effect. | 12 hours after surgery | |
Secondary | 3 Months-Chronic Pain-weekly Frequency of Pain | 0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant | 3 months | |
Secondary | 6 Months-Chronic Pain-weekly Frequency of Pain | 0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant | 6 months | |
Secondary | 12 Months-Chronic Pain-weekly Frequency of Pain | 0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant | 12 months |
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