Back to resultsTraumatologic Acute Pain Management With Fentanyl Transdermal Therapeutic System (TTS)
Primary Purpose
Hip Fractures (ICD-10 72.01-72.2)
Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Fentanyl Transdermal System
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures (ICD-10 72.01-72.2)
Eligibility Criteria
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
Sites / Locations
- Medical University Hospital LKH Graz
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Standard pain management
Modified pain management
Arm Description
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)
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04026022
First Posted
July 17, 2019
Last Updated
July 21, 2020
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT04026022
Brief Title
Traumatologic Acute Pain Management With Fentanyl Transdermal Therapeutic System (TTS)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 30, 2019 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures (ICD-10 72.01-72.2)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard pain management
Arm Type
Placebo Comparator
Arm Description
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)
Arm Title
Modified pain management
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fentanyl Transdermal System
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo plaster in the ER or PACU
Primary Outcome Measure Information:
Title
Patient's wellbeing in the awakening room
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Complication rate (delirium, periprosthetic fractures, wound infections etc)
Description
All complications occuring during hospital stay will be statistically evaluated for differences between the two study groups.
Time Frame
Through study completion, an average of 10 days
Title
Efficacy of the pain management in reducing pain
Description
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.
Time Frame
Through study completion, an average of 10 days
Title
Interview assessed identification of selfreported parameters influencing patient-wellbeing
Description
Feedback interviews with the patients giving them the opportunity to express what influenced their wellbeing the most.
Time Frame
Through study completion, an average of 72 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical University Hospital LKH Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication of our results, all collected data will be made available in respect of data privacy laws.
Learn more about this trial
Traumatologic Acute Pain Management With Fentanyl Transdermal Therapeutic System (TTS)
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