Postoperative Pain Therapy With Hydromorphone Using TCI-PCA

University of Erlangen-Nürnberg Medical School

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Hydromorphone

Study type: Interventional

Funder types: Other

Identifiers

NCT02035709

2013-002875-16 (EudraCT Number)

TCI-PCA-001

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

TCI-PCA

Active Comparator group

Description:

Intravenous Patient-Controlled Analgesia with Target-Controlled Infusion

Treatment:

Drug: Hydromorphone

PCA

Active Comparator group

Description:

Intravenous Patient-Controlled Analgesia

Treatment:

Drug: Hydromorphone