Postoperative Pain
Conditions
Keywords
Therapy
Brief summary
Treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target concentrations in blood compared to conventional patient-controlled analgesia after planed cardiac surgery
Interventions
DRUGHydromorphone
Hydromorphone is given by PCA or TCI-PCA. The TCI-PCA System steer the hydromorphone infusion pump to achieve plasma concentrations of hydromorphone in predefined increasing steps on patient request and in predefined decreasing steps on lack of patient request within predefined plasma concentration range, lock times 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
Yes
Inclusion criteria
* Written informed consent * Age between 40 and 85 years, both genders * Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay
Exclusion criteria
* Administration of other analgesics or sedatives, if not administered in stable dosage for at least 14 days or if not used for premedication and surgery * Administration of hydromorphone in the period between screening and surgery * Severe hepatic or renal impairment in medical history * BMI ≥35 kg/m² * ASA ≥4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hydromorphone Plasma Concentrations | Day 0 (Visit 2 on day of surgery): -1, 3, 30, 90, 91, 93, 95, 97, 100 min after start of hydromorphone infusion but before extubation; one sample each hour for the following 17 hours after extubation | Predictive accuracy of the Erlanger pharmacokinetic model of hydromorphone administered via TCI, TCI-PCA and conventional PCA during the early postoperative stage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Score | Day 0 (Visit 2 on day of surgery): -1, 3, 30, 90, 91, 93, 95, 97, 100 min after start of hydromorphone infusion but before extubation; one sample each hour for the following 17 hours after extubation | Comparison between hydromorphone TCI-PCA and conventional hydromorphone PCA during the early postoperative stage regarding analgetic efficiency |
Other
| Measure | Time frame | Description |
|---|---|---|
| Amount of Hydromorphone Administered | Day 1 (Visit 3 on first day after surgery) | Comparison between hydromorphone TCI-PCA and conventional hydromorphone PCA during the early postoperative stage regarding the amount of hydromorphone administered |
Countries
Germany
Outcome results
None listed