E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative pain treatment after elective cardiac surgery |
Postoperative Schmerztherapie nach elektiven kardiochirurgischen Eingriffen |
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E.1.1.1 | Medical condition in easily understood language |
Pain treatment after planned cardiac surgery |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Comparison in analgetic efficiency of hydromorphone TCI-PCA vs. conventional morphine PCA in the early postoperative period. |
Vergleich der Hydromorphon-TCI-PCA vs. konventioneller Morphin-PCA in der frühen postoperativen Phase hinsichtlich der analgetischen Effizienz. |
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E.2.2 | Secondary objectives of the trial |
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. |
Vergleich der verbrauchte Mengen und Anforderungsprofile zwischen den beiden Behandlungsgruppen.
Spitzenkonzentrationen von Hydromorphon und Morphin unter TCI-PCA bzw. konventioneller PCA.
Beschreibung und Vergleich der Sicherheit und Verträglichkeit der frühen postoperativen Schmerztherapie mittels Hydromorphon-TCI-PCA vs. konventioneller Morphin-PCA.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Written informed consent.
Age between 40 and 85 years, both genders.
Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay. |
Schriftliche Zustimmung zur Studienteilnahme.
Männliche oder weibliche Person im Alter von 40 bis 85 Jahren.
Elektiver kardiochirurgischer Eingriff mit Thorakotomie und anschließendem Aufenthalt auf der Intensivstation. |
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E.4 | Principal 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. |
Einnahme von Analgetika oder Sedativa, soweit sie nicht seit mindestens 14 Tagen in unveränderter Dosierung oder zur Prämedikation oder Durchführung des kardiochirurgischen Eingriffs angewendet werden.
Gabe von Hydromorphon oder Morphin im Zeitraum zwischen Screening-Termin (Visite 1, Tag -3 bis -1) bis zu Beginn von Visite 2 (Tag 1).
BMI ≥35 kg/m².
ASA ≥4. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of the course over time of the NRS-11 values between the treatment groups. |
Vergleich des Verlaufs der NRS-11-Werte zwischen den beiden Behandlungsgruppen. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During treatment visit (visit 2). |
Während der Behandlungsphase (Visite 2). |
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E.5.2 | 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. |
Vergleich der applizierten Mengen an Hydromorphon und Morphin unter TCI-PCA bzw. konventioneller PCA in Morphinäquivalenten.
Vergleich der Häufigkeit und Menge an analgetischer Rescue-Medikation zwischen den beiden Behandlungsgruppen.
CMax von Hydromorphon und Morphin unter TCI-PCA bzw. konventioneller PCA nach entsprechender Normierung auf dem beobachteten Wertintervall.
Vergleich der Zahl von AEs und SAEs zwischen den beiden Behandlungsgruppen.
Vergleich der Häufigkeit und Dauer von MOAA/S-Werten ≤3 zwischen den beiden Behandlungsgruppen.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During treatment visit (visit 2). |
Während der Behandlungsphase (Visite 2). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
Letzte Visite des letzten Studienteilnehmers |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |