Comparison of the standard pain medication management versus a modified one, in which a painmedication liberating plaster is utilised, for adult patients with a fracture of the thigh near to the hip.
Phase 1
- Conditions
- Elderly Patientens with hip-fracture (ICD-10 72.01-72.2)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2019-000178-50-AT
- Lead Sponsor
- Medical University of Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Adult Patients presenting with hip fractures that must be sheduled for emergency operation (ICD S72.01-S72.2)
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Severe liver damage, ongoing dialysis therapy, Monoamine oxidase inhibitor intake,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Examination whether a modified perioperative pain management system utilising Fentanyl TTS can improve Patient's wellbeing.;Secondary Objective: Examination whether a modified pain management system utilising a plaster slowly releasing medication leads to a higher Patient's wellbeing-rate.;Primary end point(s): Patient's wellbeing in the awakening room before transportation to the normal ward;Timepoint(s) of evaluation of this end point: in the awakening room before transportation to the normal ward, approximately 2-4 hours postoperatively
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Complicationrates (delirium, periprothetic fractures, Woundinfections etc), efficacy of the pain managements in reducing pain, identification of parametes influencing patient-wellbeing;Timepoint(s) of evaluation of this end point: Ongoing until hospital discharge (complications and efficacy of the pain management)<br>before operation and 12h after admission (Patients wellbeing and questionaire about parametes influencing patient-wellbeing)<br>Approximately 72 h after Operation (Patients wellbeing and questionaire about parametes influencing patient-wellbeing)<br>