Precision Analgesia for Cardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-110
SponsorKathirvel Subramaniam
About this trial
The proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research. This research focuses on two of the most commonly used oral opioid analgesics, oxycodone, and methadone in elderly adults undergoing cardiac surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Elderly cardiac surgical patients over 60 years of age
Disqualifiers
Methadone allergy
Morbid obesity (BMI >40kg/cm2)
Severe sleep apnea
Severe pulmonary disease requiring oxygen therapy
Trial population
Elderly cardiac surgical patients over 60 years of age Both genders are included All races and ethnic groups undergoing elective open cardiac surgery through midline sternotomy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Determine Genetic Factors - Opioid Related Adverse Events (RD)
Respiratory depression will be measured with binary yes/no responses obtained either via self-report from the patient or reported by the clinical care staff.
Time frame
Immediately post-surgery during hospital stay2
Determine Genetic Factors - Opioid Related Adverse Events (PONV)
Post-operative nausea and vomiting will be measured with binary yes/no responses obtained either via self-report from the patient or reported by the clinical care staff.
Time frame
Immediately post-surgery during hospital stay3
Determine Genetic Factors - Opioid Related Adverse Events (Excessive Sedation)
Excessive sedation will be measured with binary yes/no responses obtained either via self-report from the patient or reported by the clinical care staff.
Time frame
Immediately post-surgery during hospital stay4
Determine Genetic Factors - Uncontrolled severe pain
We postulate that specific CYP2B6, ABCB1, OPRM1, FAAH, and ORM1 genetic variants identify patients at risk for poor pain relief and ORADE with methadone in the immediate post-surgical period. Pain will be measured by the Numerical Rating Scale (NRS) in which 0 = no pain at all and 10 = worst pain imaginable. This will be self-reported responses by the patient.
Time frame
Immediately post-surgery during hospital staySecondary outcomes
1
Opioid use post-operatively
Opioid usage will be recorded via SOAPP-R, a 24-item validated opioid assessment. A score of 18 or higher is considered positive.
Time frame
Post-operative Day 5 to 6-months post-operative2
Patient-Reported Outcomes Measurement Information System
The PROMIS-29 v2.0 will be collected for this outcome measure. The PROMIS survey is scored by the following T-Score Cut Points: 20-55 = better health, 55-60 = mild, 61-69 = moderate, and 71+ = worse health. The general population mean = 50 (SD = 10).
Time frame
Post-operative Day 5 to 6-months post-operative3
Incidence of Chronic Persistent Surgical Pain (CPSP)
CPSP will be obtained via patient-self report as yes/no responses for follow-up assessments. This measure will be reported as mean(SD) for positive CPSP subjects.
Time frame
Post-operative Day 5 to 6-months post-operativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kathirvel Subramaniam
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov
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