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

Hip Fractures (ICD-10 72.01-72.2) Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026022
• Other study ID #: 2gas
• Status: Completed
• Phase: Phase 3
• Start date: June 30, 2019
• Est. completion date: March 6, 2020

Study information

• Verified date: July 2019
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients with hip fractures that have to be operated (ICD S72.01-S72.2)

Exclusion Criteria:

• severe liver damage

• ongoing dialysis therapy

• Monoamine oxidase inhibitor intake

• inability to give consent to trial participation

Related Conditions & MeSH terms

• Hip Fractures
• Hip Fractures (ICD-10 72.01-72.2)

Intervention

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.
• Placebo
Placebo plaster in the ER or PACU

Locations

Country	Name	City	State
Austria	Medical University Hospital LKH Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's wellbeing in the awakening room	Wellbeing assessed with the "Anaesthesiological Questionnaire" (ANP) which is a self-rating method for the assessment of postoperative complaints and patient wellbeing. The rating scales from 0 to 3, with 0="none" and 3="strongly". Higher wellbeing values represent a better outcome.	1 year
Secondary	Complication rate (delirium, periprosthetic fractures, wound infections etc)	All complications occuring during hospital stay will be statistically evaluated for differences between the two study groups.	Through study completion, an average of 10 days
Secondary	Efficacy of the pain management in reducing pain	Pain will be assessed with the (verbal) Numerical Rating Scale (NRS) and statistically evaluated for differences between the two study groups. NRS scales from 1 to 10, with 1 describing the lowest pain score and 10 the highest pain score. Lower NRS describes a better outcome.	Through study completion, an average of 10 days
Secondary	Interview assessed identification of selfreported parameters influencing patient-wellbeing	Feedback interviews with the patients giving them the opportunity to express what influenced their wellbeing the most.	Through study completion, an average of 72 hours postoperatively