E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Elderly Patientens with hip-fracture (ICD-10 72.01-72.2) |
Ältere Patienten mit einer Hüftnahenfraktur (ICD-10 72.01-72.2) |
|
E.1.1.1 | Medical condition in easily understood language |
Elderly Patientens with thigh fractures near the hip. |
Ältere Patienten mit einer hüftnahen Knochenbruch. |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
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 |
Examination whether a modified perioperative pain management system utilising Fentanyl TTS can improve Patient's wellbeing. |
Untersuchung ob durch ein modifiziertes perioperatives Schmerzmittelschema, welches Fentanyl TTS verwendet, das Wohlbefinden der Patienten gesteigert werden kann. |
|
E.2.2 | Secondary objectives of the trial |
Examination whether a modified pain management system utilising a plaster slowly releasing medication leads to a higher Patient's wellbeing-rate. |
Untersuchung ob durch ein modifiziertes Schmerzmittelschema, in dem ein Schmerzmittelpflaster mit konstanter Mediakementenfreisetzung verwendet wird, das Wohlbefinden der Patienten gesteigert werden kann. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult Patients presenting with hip fractures that must be sheduled for emergency operation (ICD S72.01-S72.2) |
Erwachsene Patienten mit Hüftnahen-Frakturen die akut operativ versorgt werden müssen (ICD S72.01-S72.2) |
|
E.4 | Principal exclusion criteria |
Severe liver damage, ongoing dialysis therapy, Monoamine oxidase inhibitor intake, |
Schwere Leberinsuffizienz, terminale Niereninsuffizienz mit Dialysetherapie, Monoaminoxidase-Dauertherapie, |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Patient's wellbeing in the awakening room before transportation to the normal ward |
Wohlbefinden der Patienten im Aufwachraum vor Rückverlegung auf Normalstation |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
in the awakening room before transportation to the normal ward, approximately 2-4 hours postoperatively |
im Aufwachraum vor Rückverlegung auf Normalstation, ungefähr 2-4 Stunden nach der Operation |
|
E.5.2 | Secondary end point(s) |
Complicationrates (delirium, periprothetic fractures, Woundinfections etc), efficacy of the pain managements in reducing pain, identification of parametes influencing patient-wellbeing |
Komplikationserfassung (Delir, periprothethische Frakturen, Wundinfektionen etc), Effizienz in der Schmerzkompensation im Vergleich zur Standardtherapie, Identifikation von Einflussparametern des Wohlbefindens |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Ongoing until hospital discharge (complications and efficacy of the pain management) before operation and 12h after admission (Patients wellbeing and questionaire about parametes influencing patient-wellbeing) Approximately 72 h after Operation (Patients wellbeing and questionaire about parametes influencing patient-wellbeing)
|
Tägliche Erfassung der Komplikationen und Effizienz der Schmerztherapie Erhebung des Wohlbefindens und Identifikation von Einflussparametern auf das Wohlbefinden vor Operation (mind. 12 Stunden nach Aufnahme) sowie ca. 72 Stunden nach der Operation. |
|
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 | Yes |
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 | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
standard Schmerzmittelschema, mit einem wirkstoffreien Placebopflaster |
Standard pain management in addition to a medication free placebo plaster |
|
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
|
LVLS (follow up) |
LVLS (follow up) |
|
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 |