Treatment of postoperative pain after planned cardiac surgery using hydromorphone patient-controlled analgesia with target concentrations in blood compared to morphine patient-controlled analgesia

Phase 1

Conditions: Postoperative pain treatment after elective cardiac surgery
MedDRA version: 18.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-004088-19-DE

Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Written informed consent.
Age between 40 and 85 years, both genders.
Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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 or morphine in the period between secreening and admission to the ICU.
Severe hepatic or renal impairment in medical history.
BMI =35 kg/m².
ASA =4.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparison in analgetic efficiency of hydromorphone TCI-PCA vs. conventional morphine PCA in the early postoperative period.;Secondary Objective: ?Comparison of amount and consumption profiles between treatment groups.<br>?Peak concentrations of hydromorphone and morphine under TCI-PCA and conventional PCA, respectively.<br>?Description and comparison of safety and tolerability of early postoperative pain treatment using hydromorphone TCI-PCA vs. conventional morphine PCA.;Primary end point(s): Comparison of the course over time of the NRS-11 values between the treatment groups.;Timepoint(s) of evaluation of this end point: During treatment visit (visit 2).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Comparison of amounts of hydromrophone and morphine administered by TCI-PCA and conventional PCA, respectively, in morphine equivalents.<br>Comparison of frequency and amount of analgetic rescue medication between treatment groups.<br>CMax of hydromorphone and morphine using TCI-PCA and conventional PCA, respectively.<br>Comparison of number of AEs and SAEs between treatment groups.<br>Comparison of frequency and duration of MOAA/s values =3 between treatment groups.;Timepoint(s) of evaluation of this end point: During treatment visit (visit 2).