NCT04026022

Traumatologic Acute Pain Management With Fentanyl Transdermal Therapeutic System (TTS)

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aim of the study is an examination whether a modified perioperative pain management system, that integrates the 2017 European Society of Anaesthesiology (ESA) guidelines for treatment of postoperative Delirium, can improve patient's wellbeing in comparison to the current certified standard management.

Detailed description

Aim of the study is to evaluate whether the integration of the 2017 ESA guidelines for treatment of postoperative Delirium in a pain management, can improve patient's wellbeing in comparison to the current certified standard management. Adherence to the modified management includes minimizing nil per os time, renouncing benzodiazepines, 1.8 ltr crystalloid infusion per day, simplified standard medication option and postoperative 12µg/h Fentanyl TTS for 72h (for wound pain).

Conditions

• Hip Fractures (ICD-10 72.01-72.2)

Interventions

Type	Name	Description
DRUG	Fentanyl Transdermal System	Patients will be treated perioperatively with a new pain management, that has been modified to integrate the 2017 ESA guidelines on prevention/treatment of postoperative delirium. Moreover patients will be administered a 12µg/h Fentanyl TTS in the ER or PACU. The ER TTS will only be administered if the patients still has mild to intense pain after initial intravenous (i.v.) treatment as well as reposition of the fractured hip. Further aspects of the modified management are: avoiding benzodiazepines, allowing oral fluids up to 2 hours before surgery, intraoperative monitoring of anaesthesia depth and at least 1,8 ltr crystalloid infusion per day.
DRUG	Placebo	Placebo plaster in the ER or PACU

Timeline

• Start date: 2019-06-30
• Primary completion: 2020-03-06
• Completion: 2020-03-06
• First posted: 2019-07-19
• Last updated: 2020-07-22

Locations

1 site across 1 country: Austria