Femur FractureNCT06531564
Emergency Department Management of Femur Fractures
An observational study of Femur Fracture and Pain, Joint, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Comparison of emergency department management of patients presenting with isolated hip fracture: comparison of methods used in pain management, monitoring, and treatment; comparison of hospitalization durations; comparison of mortality Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femur Fracture, Pain, Joint, Analgesia
- Type of treatment
- Injection or infusion
- How many people
- 155 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Adult, Older adult
Study population: patients over the age of 18 years administered to emergency department with isolated femur fracture receving analgesia
Who may be able to join
- Patients over the age of 18 years
Who cannot join
- Forensic cases Patients who do not have follow-up in our healthcare system or cannot be followed up Patients with allergies to opioids or local anesthetics Patients with suspected neuropathy among defined complications of diabetes mellitus Patients requiring treatment for ≥2 different types of fractures upon emergency department admission
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik City Hospital
Ankara, Yenimahalle, 06110
About this study
Official title: Emergency Department Management of Isolated Femur Fracture Patients
Comparison of emergency department management of patients presenting with isolated hip fracture: comparison of methods used in pain management, monitoring, and treatment; comparison of hospitalization durations; comparison of mortality
Read the detailed description
Patient demographics, mechanism of injury, femur fracture classification, associated treatments, pre-procedural pain scoring, post-procedural pain scoring, orthopedic consultation, and patient outcomes (discharge, admission to ward or ICU, mortality) will be recorded on the data form.
For acute pain management, the timing of treatment administration, effectiveness of the applied method based on pre- and post-procedural pain scoring systems will be assessed. Post-procedural pain scores will be collected at 30, 60, and 120 minutes.
Long-term complications as a result of hospitalization following emergency department follow-ups will include monitoring on days 7 and 21 for mortality and morbidity.
The patients will be analyzed in 5 groups based on the treatments administered in the emergency department.
- IV Opioid
- IV NSAID
- IV acetaminophen
- Femoral nerve block
- PENG block The researcher will not interfere with the treatment decision made by the responsible physician or the treatment process
- Conditions
- Femur Fracture, Pain, Joint, Analgesia
- Keywords
- isolated femur fracture, analgesia, emergency department, nerve block
- Medical subject headings
- Femoral Fractures, Arthralgia, Agnosia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Opioid group | patients receiving intravenous opioid agents after femur fracture | |
| NSAID | patients receiving intravenous NSAID agents after femur fracture | |
| acetaminophen | patients receiving intravenous acetaminophen after femur fracture | |
| Femoral nerve block | patients receiving femoral nerve blocking treatment after femur fracture | |
| PENG block | patients receiving PENG blocking treatment after femur fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
effective analgesia after receiving treatment
patients will be evaluated before and after analgesic treatments according to pain scales ( visual analogue scale, verbal pain intensity scale, PAINAD ( pain assessment in advanced dementia) scale andvisual analogue scale), effective pain management will be primary outcome
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Aug 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Responsible party
- Sponsor
- Investigators
- gulsen akcay, ass. prof., Study director, ass. prof. of organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531564
- Sponsor's protocol ID
- isolated femur fracture
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simic A, Nesek Adam V, Rosic D, Kocet N, Svetec M, Herceg A, Keranovic A, Rasic Z. PERIPHERAL NERVE BLOCKS FOR HIP FRACTURES IN EMERGENCY MEDICINE. Acta Clin Croat. 2022 Jun;61(Suppl 1):78-83. doi: 10.20471/acc.2022.61.s1.13.
PubMed 36304813Thiam CN, Khor HM, Pang GHM, Lim WC, Shanmugam T, Chandrasekaran CSK, Singh S, Zakaria MIB, Ong T. Hip fracture management in the emergency department and its impact on hospital outcomes: a retrospective cross-sectional analysis. Eur Geriatr Med. 2022 Oct;13(5):1081-1088. doi: 10.1007/s41999-022-00654-0. Epub 2022 May 14.
PubMed 35567676Fahey A, Cripps E, Ng A, Sweeny A, Snelling PJ. Pericapsular nerve group block for hip fracture is feasible, safe and effective in the emergency department: A prospective observational comparative cohort study. Emerg Med Australas. 2022 Dec;34(6):884-891. doi: 10.1111/1742-6723.14013. Epub 2022 Jun 14.
PubMed 35701386
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Management of Isolated Femur Fracture Patients
- ClinicalTrials.gov ID
- NCT06531564
- Acronym / sponsor ID
- isolated femur fracture
- Conditions
- Femur Fracture, Pain, Joint, Analgesia
- Keywords
- isolated femur fracture, analgesia, emergency department, nerve block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 1 Aug 2024 (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.
Comparison of emergency department management of patients presenting with isolated hip fracture: comparison of methods used in pain management, monitoring, and treatment; comparison of hospitalization durations; comparison of mortality
Detailed description
Patient demographics, mechanism of injury, femur fracture classification, associated treatments, pre-procedural pain scoring, post-procedural pain scoring, orthopedic consultation, and patient outcomes (discharge, admission to ward or ICU, mortality) will be recorded on the data form.
For acute pain management, the timing of treatment administration, effectiveness of the applied method based on pre- and post-procedural pain scoring systems will be assessed. Post-procedural pain scores will be collected at 30, 60, and 120 minutes.
Long-term complications as a result of hospitalization following emergency department follow-ups will include monitoring on days 7 and 21 for mortality and morbidity.
The patients will be analyzed in 5 groups based on the treatments administered in the emergency department.
- IV Opioid
- IV NSAID
- IV acetaminophen
- Femoral nerve block
- PENG block The researcher will not interfere with the treatment decision made by the responsible physician or the treatment process
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Opioid group | – | –patients receiving intravenous opioid agents after femur fracture |
| NSAID | – | –patients receiving intravenous NSAID agents after femur fracture |
| acetaminophen | – | –patients receiving intravenous acetaminophen after femur fracture |
| Femoral nerve block | – | –patients receiving femoral nerve blocking treatment after femur fracture |
| PENG block | – | –patients receiving PENG blocking treatment after femur fracture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients over the age of 18 years administered to emergency department with isolated femur fracture receving analgesia
Key inclusion criteria (1 listed)
- Patients over the age of 18 years
Key exclusion criteria (1 listed)
- Forensic cases Patients who do not have follow-up in our healthcare system or cannot be followed up Patients with allergies to opioids or local anesthetics Patients with suspected neuropathy among defined complications of diabetes mellitus Patients requiring treatment for ≥2 different types of fractures upon emergency department admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
effective analgesia after receiving treatment
Time frame: 24 hours
patients will be evaluated before and after analgesic treatments according to pain scales ( visual analogue scale, verbal pain intensity scale, PAINAD ( pain assessment in advanced dementia) scale andvisual analogue scale), effective pain management will be primary outcome
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 1 Aug 2024.
- Background: PubMed 36304813Simic A, Nesek Adam V, Rosic D, Kocet N, Svetec M, Herceg A, Keranovic A, Rasic Z. PERIPHERAL NERVE BLOCKS FOR HIP FRACTURES IN EMERGENCY MEDICINE. Acta Clin Croat. 2022 Jun;61(Suppl 1):78-83. doi: 10.20471/acc.2022.61.s1.13.
- Background: PubMed 35567676Thiam CN, Khor HM, Pang GHM, Lim WC, Shanmugam T, Chandrasekaran CSK, Singh S, Zakaria MIB, Ong T. Hip fracture management in the emergency department and its impact on hospital outcomes: a retrospective cross-sectional analysis. Eur Geriatr Med. 2022 Oct;13(5):1081-1088. doi: 10.1007/s41999-022-00654-0. Epub 2022 May 14.
- Background: PubMed 35701386Fahey A, Cripps E, Ng A, Sweeny A, Snelling PJ. Pericapsular nerve group block for hip fracture is feasible, safe and effective in the emergency department: A prospective observational comparative cohort study. Emerg Med Australas. 2022 Dec;34(6):884-891. doi: 10.1111/1742-6723.14013. Epub 2022 Jun 14.
- Individual participant dataSharing planned: No
Related trials for Femur Fracture
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
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.
gulsen akcay, ass. prof. study director
ass. prof. of organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femur Fracture and Pain, Joint, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 1 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 1 Aug 2024. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
effective analgesia after receiving treatment (time frame: 24 hours). 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 NCT06531564, which also lists 3 linked publications.
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 1 Aug 2024.