Postoperative Pain Therapy With Hydromorphone TCI-PCA vs. Morphine PCA

University of Erlangen-Nürnberg Medical School

Status and phase: Completed; Phase 4

Conditions: Acute Postoperative Pain

Treatments: Drug: Hydromorphone; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02483221

TCI-PCA-002

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

TCI-PCA

Active Comparator group

Treatment:

Drug: Hydromorphone

PCA

Active Comparator group

Treatment:

Drug: Morphine