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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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.

Conditions
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Hip Fractures (ICD-10 72.01-72.2)

Intervention / Treatment
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* Drug: Fentanyl Transdermal System
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard pain management<br>Besides the standard pain management a placebo TTS (normal wound plaster) will be administered in the Emergency Room (ER) or Post Anaesthesia Care Unit (PACU) | Drug: Placebo<br>* Placebo plaster in the ER or PACU<br>|
| Experimental: Modified pain management<br>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 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: Fentanyl Transdermal System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |