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.

Perioperative off-label application (from admission up to 72 hours postoperatively) of Fentanyl TTS as part of a pain management in comparison to a certified pain medication management in adult patients with a hip fracture - a randomised, controlled, doubleblind clinical drug investigation phase III according (austrian) drug law. - Traumatologic acute pain management with Fentanyl TTS - A Phase III Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000178-50-AT

Enrollment

150

Registered

2019-05-22

Start date

2019-06-19

Completion date

Unknown

Last updated

2024-03-12

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

Conditions

Elderly Patientens with hip-fracture (ICD-10 72.01-72.2)

Interventions

Product Name: modifiziertes Schema/modifed pain management Pharmaceutical Form: Product Name: standard schema/standard pain management Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Severe liver damage, ongoing dialysis therapy, Monoamine oxidase inhibitor intake,

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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) 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)	—

Measure

Time frame

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) 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)

—

Countries

Austria

Contacts

Public ContactDepartment of Gen. Anaesthesia

Medical University of Graz

00433163851490

Outcome results

None listed

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