Acute Postoperative Pain
Conditions
Brief summary
Treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target-controlled infusion compared to conventional patient-controlled analgesia with morphine after elective cardiac surgery
Interventions
DRUGHydromorphone
Hydromorphone is given intravenously by TCI-PCA. The TCI-PCA system steer the hydromorphone infusion pump to achieve plasma and effect-site concentrations of hydromorphone in predefined increasing steps on patient request and in predefined decreasing steps on lack of patient request within predefined plasma and effect-site concentration range, lockout times and infusion speed.
DRUGMorphine
Morphine is given intravenously by PCA. The PCA pump administers a predefined bolus dose on patient request considering the predefined lockout time and infusion speed.
Sponsors
German Federal Ministry of Education and Research
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay
Exclusion criteria
* Administration of other analgesics or sedatives, if not administered in stable dosages for at least 14 days or if not used for premedication and surgery * Administration of hydromorphone or morphine in the period between screening and surgery * Severe hepatic or renal impairment in medical history * BMI\>= 35 ASA\>= 4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Score | up to 17 hours after extubation | Comparison of pain analgetic efficacy between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Observer's Assessment of Alertness/Sedation Scale | up to 17 hours after extubation | Comparison of opioid induced sedation level between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage |
| Postoperative Nausea and Vomiting | day of surgery | Comparison of opioid associated nausea and vomiting between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage |
| Respiratory Frequency | up to 17 hours after extubation | Comparison of opioid induced respiratory depression between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage |
Countries
Germany
Outcome results
None listed