Hip Fractures (ICD-10 72.01-72.2)Phase 3NCT04026022
Traumatologic Acute Pain Management With Fentanyl Transdermal Therapeutic System (TTS)
A Phase 3 study testing Fentanyl Transdermal System in people with Hip Fractures (ICD-10 72.01-72.2), run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures (ICD-10 72.01-72.2)
- What is being tested?
- Fentanyl Transdermal System
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 1 siteAustria
- Study dates
- 30 Jun 2019to 6 Mar 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients with hip fractures that have to be operated (ICD S72.01-S72.2)
Who cannot join
- severe liver damage
- ongoing dialysis therapy
- Monoamine oxidase inhibitor intake
- inability to give consent to trial participation
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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).
- Conditions
- Hip Fractures (ICD-10 72.01-72.2)
- Being tested
- Fentanyl Transdermal System, Placebo
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl Transdermal SystemDrug
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.
PlaceboDrug
Placebo plaster in the ER or PACU
| Study group | Role | What they receive |
|---|---|---|
| Standard pain management | Placebo comparator | 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) Receives: Drug: Placebo |
| Modified pain management | Experimental | 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 Receives: Drug: Fentanyl Transdermal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start30 Jun 2019
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip Fractures (ICD-10 72.01-72.2)Studies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026022
- Sponsor's protocol ID
- 2gas
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2019
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of our results, all collected data will be made available in respect of data privacy laws.
Publications
Labmayr V, Rief M, Reinbacher P, Gebauer D, Smigaj J, Sandner-Kiesling A, Papamargaritis V, Michaeli K, Bornemann-Cimenti H, Schittek GA. Simplified Pain Management Including Fentanyl TTS in PACU Patients With Hip Fracture Surgery to Improve Patients' Well-Being: A Double-Blind Randomized Trial. J Perianesth Nurs. 2024 Jun;39(3):461-467. doi: 10.1016/j.jopan.2023.10.004. Epub 2023 Dec 11.
PubMed 38085188
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04026022
- Acronym / sponsor ID
- 2gas
- Conditions
- Hip Fractures (ICD-10 72.01-72.2)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard pain management | Placebo comparator | Drug: PlaceboBesides the standard pain management a placebo TTS (normal wound plaster) will be administered in the Emergency Room (ER) or Post Anaesthesia Care Unit (PACU) |
| Modified pain management | Experimental | Drug: Fentanyl Transdermal SystemPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients with hip fractures that have to be operated (ICD S72.01-S72.2)
Key exclusion criteria (4 listed)
- severe liver damage
- ongoing dialysis therapy
- Monoamine oxidase inhibitor intake
- inability to give consent to trial participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl Transdermal SystemPatients 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. | Drug | Modified pain management |
| PlaceboPlacebo plaster in the ER or PACU | Drug | Standard pain management |
Primary outcome
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.
3 secondary outcomes
Complication rate (delirium, periprosthetic fractures, wound infections etc)
Time frame: Through study completion, an average of 10 days
Efficacy of the pain management in reducing pain
Time frame: Through study completion, an average of 10 days
Interview assessed identification of selfreported parameters influencing patient-wellbeing
Time frame: Through study completion, an average of 72 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Derived from this study: PubMed 38085188Labmayr V, Rief M, Reinbacher P, Gebauer D, Smigaj J, Sandner-Kiesling A, Papamargaritis V, Michaeli K, Bornemann-Cimenti H, Schittek GA. Simplified Pain Management Including Fentanyl TTS in PACU Patients With Hip Fracture Surgery to Improve Patients' Well-Being: A Double-Blind Randomized Trial. J Perianesth Nurs. 2024 Jun;39(3):461-467. doi: 10.1016/j.jopan.2023.10.004. Epub 2023 Dec 11.
- Individual participant dataSharing planned: Yes. After publication of our results, all collected data will be made available in respect of data privacy laws.
Related trials for Hip Fractures (ICD-10 72.01-72.2)
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Not yet recruitingObservational study
Improving Shared DECISion-making in oldEr Hip Fracture Patients Living With Frailty
Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures), Hip Fractures (ICD-10 72.01-72.2)
RecruitingObservational study
Mobility and Activity of Daily Living Outcomes After a Hip Fracture.
Hip Fractures (ICD-10 72.01-72.2)
RecruitingObservational study
Population Pharmacokinetics and Pharmacodynamics of Ciprofol
Hip Fractures (ICD-10 72.01-72.2), Osteoarthritis, Knee and Hip
Recruiting
Pre- and Postoperative Chest Therapy With Positive Expiratory Pressure (PEP) to Prevent Hospital-acquired Pneumonia
Hip Fractures (ICD-10 72.01-72.2)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fentanyl Transdermal System in people with Hip Fractures (ICD-10 72.01-72.2), run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's wellbeing in the awakening room (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04026022, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.