Overview

Postoperative Pain Therapy With Hydromorphone Using TCI-PCA

Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Collaborator:
German Federal Ministry of Education and Research
Treatments:
Hydromorphone
Criteria
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