Hip Fractures (ICD-10 72.01-72.2)
Conditions
Brief 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).
Interventions
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.
DRUGPlacebo
Placebo plaster in the ER or PACU
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's wellbeing in the awakening room | 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
| Measure | Time frame | Description |
|---|---|---|
| Complication rate (delirium, periprosthetic fractures, wound infections etc) | 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. |
| Efficacy of the pain management in reducing pain | 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. |
| Interview assessed identification of selfreported parameters influencing patient-wellbeing | 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. |
Countries
Austria
Outcome results
None listed