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

Postoperative pain treatment after elective cardiac surgery using patient-controlled target-controlled infusion (TCI-PCA) with hydromorphone vs. patient-controlled analgesia (PCA) with morphine - TCI-PCA Hydromorphon vs. PCA Morphin

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004088-19-DE

Enrollment

Unknown

Registered

2014-11-20

Start date

2014-12-12

Completion date

Unknown

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain treatment after elective cardiac surgery MedDRA version: 18.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865

Interventions

Trade Name: Palladon Pharmaceutical Form: Solution for injection INN or Proposed INN: HYDROMORPHONE HYDROCHLORIDE CAS Number: 71-68-1 Other descriptive name: HYDROMORPHONE HYDROCHLORIDE Concentration

Eligibility

Sex/Gender

All

Inclusion 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. 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

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.

Design outcomes

Primary

Measure	Time frame
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. ? Peak concentrations of hydromorphone and morphine under TCI-PCA and conventional PCA, respectively. ? 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).	—

Measure

Time frame

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. ? Peak concentrations of hydromorphone and morphine under TCI-PCA and conventional PCA, respectively. ? 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).

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Secondary

Measure	Time frame
Secondary end point(s): Comparison of amounts of hydromrophone and morphine administered by TCI-PCA and conventional PCA, respectively, in morphine equivalents. Comparison of frequency and amount of analgetic rescue medication between treatment groups. CMax of hydromorphone and morphine using TCI-PCA and conventional PCA, respectively. Comparison of number of AEs and SAEs between treatment groups. 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).	—

Measure

Time frame

Secondary end point(s): Comparison of amounts of hydromrophone and morphine administered by TCI-PCA and conventional PCA, respectively, in morphine equivalents. Comparison of frequency and amount of analgetic rescue medication between treatment groups. CMax of hydromorphone and morphine using TCI-PCA and conventional PCA, respectively. Comparison of number of AEs and SAEs between treatment groups. 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).

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Countries

Germany

Contacts

Public ContactAnästhesiologische Klinik

Universitätsklinikum Erlangen

christian.jeleazcov@kfa.imed.uni-erlangen.de+4991318542363

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026