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Completed

NCT Number: NCT04026022

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

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.

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Key information

Conditions

Hip Fractures (ICD-10 72.01-72.2) Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University Hospital LKH Graz

Graz, 8036, Austria

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl Transdermal System

Drug

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

Drug

Placebo plaster in the ER or PACU

Primary outcomes

  1. Patient's wellbeing in the awakening room

    Time frame: 1 year

    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.

Secondary outcomes

  1. Complication rate (delirium, periprosthetic fractures, wound infections etc)

    Time frame: Through study completion, an average of 10 days

    All complications occuring during hospital stay will be statistically evaluated for differences between the two study groups.

  2. Efficacy of the pain management in reducing pain

    Time frame: Through study completion, an average of 10 days

    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.

  3. Interview assessed identification of selfreported parameters influencing patient-wellbeing

    Time frame: Through study completion, an average of 72 hours postoperatively

    Feedback interviews with the patients giving them the opportunity to express what influenced their wellbeing the most.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 19, 2019
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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