Opioid Use, Postoperative Pain, Side Effect of Drug
Conditions
Brief summary
* Single centre observational cohort study. * 20 older patients undergoing cardiac surgery who receive standard of care pain treatment. * Postoperative ICU: blood sampling to determine morphine and metabolite (M3G, M6G, noroxycodone and oxymorphone) pharmacokinetics * After ICU discharge on general ward: blood sampling to determine morphine, oxycodone and metabolite (M3G, M6G, noroxycodone and oxymorphone) pharmacokinetics * During study monitoring of pain scores, total opioid consumption, side effects (e.g. nausea, vomiting, pruritus), sedation and delirium scores.
Detailed description
Postoperative pain after cardiac surgery in elderly patients is common and leads to postoperative complications. Opioids play an important role in treatment of postoperative pain after cardiac surgery. In frail elderly after cardiac surgery however dosing schemes for opioids are still unknown, potentially leading to inadequate treatment of pain and/or safety issues. * Single center observational cohort study * The study population includes frail patients ≥70 years undergoing elective cardiac surgery. * Primary endpoints of this study is the concentration of morphine, oxycodone and metabolites in blood over time on behalf of pharmacokinetic modelling. * Secondary endpoints of this study are the pharmacodynamic parameters of morphine, oxycodone and metabolites (M3G, M6G, noroxycodone and oxymorphone) in blood in frail patients; such as pain scores, postoperative opioid consumption, vital signs, side effects of opioids and the influence of covariates such as frailty, serum creatinine, Glomerular Filtration Rate (GFR) on the pharmacokinetics and pharmacodynamics of morphine and oxycodone.
Interventions
DRUGMorphine & Oxycodone
Morphine and Oxycodone are used in daily practice as part of standard care. Morphine and Oxycodone will be acquired through the clinical pharmacy of St Antonius and administered according to the standard postoperative pain protocol.
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
St. Antonius Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥70 years undergoing elective cardiac surgery.
Exclusion criteria
* Patients undergoing transcatheter aortic valve replacement or mitral valve repair * Contra-indication for morphine and/or oxycodone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| M3G concentration in blood over time | Until three consecutive days after ICU discharge | Analysis of serum concentrations of M3G, metabolite of morphine, for pharmacokinetic modelling |
| M6G concentration in blood over time | Until three consecutive days after ICU discharge | Analysis of serum concentrations of M6G, metabolite of morphine, for pharmacokinetic modelling |
| Noroxycodone concentration in blood over time | Until three consecutive days after ICU discharge | Analysis of serum concentrations of Noroxycodone, metabolite of oxycodone, for pharmacokinetic modelling |
| Oxymorphone concentration in blood over time | Until three consecutive days after ICU discharge | Analysis of serum concentrations of Oxymorphone, metabolite of oxycodone, for pharmacokinetic modelling |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vital sign observation: heartrate (in beats/minute) by nurse | Until three consecutive days after ICU discharge | Heartrate (HR) reported by nurse in standard care for pharmacodynamic modelling |
| Numeric Rating Scale (NRS; 0-10, 0 = none, 10 = severe) | Until three consecutive days after ICU discharge | NRS as pain measurement scale, reported by nurse in standard care, for pharmacodynamic modelling |
| Vital sign observation: saturation (in %) by nurse | Until three consecutive days after ICU discharge | Saturation (SpO2), reported by nurse in standard care for pharmacodynamic modelling |
| Postoperative opioid consumption | Until three consecutive days after ICU discharge | Postoperative opioid consumption, mg per 24 hour, for pharmacodynamic modelling |
| Side effects of opioids | Until three consecutive days after ICU discharge | Side effects of opioids (pruritis, vomiting, constipation, nausea), dichotomous (yes/no) each day by nurse/researcher, for pharmacodynamic modelling |
| Vital sign observation: bloodpressure (in mmHg) by nurse | Until three consecutive days after ICU discharge | Systolic and diastolic bloodpressure (SBP, DBP), reported by nurse in standard care for pharmacodynamic modelling |
Countries
Netherlands
Outcome results
None listed