Femoral FracturesNCT06026150
Anatomical Variations of Femoral Nerve Location in Relation to Femoral Artery
An observational study of Femoral Fractures, run by Rashid Hospital.
Trial summary
The goal of this observational study is to learn about the relative position of femoral nerve in relation to the femoral artery in patients scheduled for femoral fractures using ultrasound scanning. The classical description of femoral nerve is that it lies immediately near to artery, but it is not always true. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Fractures
- What is being tested?
- Ultrasound scanning of inguinal area for femoral nerve and artery
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2016to 15 Aug 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: femoral fracture patients admitted in Rashid hospital and trauma centre Dubai
Who may be able to join
- above the age of 18 coming for fixation of femoral fracture
Who cannot join
- below the age of 18
- patient not willing to participate
- patients with neurological illness that hinders from giving a valid consent
- patients with local pathology at inguinal region
About this study
Official title: Anatomical Variation of Femoral Nerve Location in Relation to Femoral Artery - An Ultrasonographic Evaluation
The goal of this observational study is to learn about the relative position of femoral nerve in relation to the femoral artery in patients scheduled for femoral fractures using ultrasound scanning.
The classical description of femoral nerve is that it lies immediately near to artery, but it is not always true. The nerve lies at a varying distance from the artery.
The main question it aims to answer are:
- Is the age sex and Body Mass Index affect the relationship between femoral artery and nerve?
Read the detailed description
The femoral nerve block is ideal for surgeries of the femur, knee, or anterior thigh and is often combined with a sciatic nerve block for near complete lower extremity analgesia. The classic teaching is that the femoral nerve lies lateral to femoral artery sandwiched between the fascia iliaca and iliopsoas muscle1.
Aim:
The objective of the study is to find out the anatomical variation in the site of the femoral nerve in relation to the femoral artery, with respect to the age, sex, weight and ethnicity of the patient.
- Conditions
- Femoral Fractures
- Being tested
- Ultrasound scanning of inguinal area for femoral nerve and artery
- Keywords
- femoral fracture, Ultrasound anatomy of femoral nerve
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scanning of inguinal area for femoral nerve and arteryOther
ultrasound scanning of inguinal region is done in femoral fracture patient to identify femoral artery and nerve
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability of anatomical position of Femoral Nerve with respect to Femoral artery - effect of age, sex and BMI
After positioning the patients with femoral fracture, ultrasound scanning of femoral nerve is done and the femoral nerve and arteries are identified. The distance between the femoral artery and nerve are measured using ultrasound.
Measured: From the time the patient is positioned for ultrasound scanning to obtain a clear image of the femoral nerve until the measurement of the distance between the femoral nerve and artery is completed, assessed over a period of up to 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start10 Apr 2016
- Primary completion30 Nov 2020
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Femoral FracturesStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rashid Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kurian Palavilayil Thomas Vaidyan, Rashid Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026150
- Sponsor's protocol ID
- DSREC-06/2016_03
- Status last verified
- Sep 2023
- First submitted
- 7 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fanara B, Christophe JL, Boillot A, Tatu L, Jochum D, Henri Y, Berthier F, Samain E. Ultrasound guidance of needle tip position for femoral nerve blockade: an observational study. Eur J Anaesthesiol. 2014 Jan;31(1):23-9. doi: 10.1097/01.EJA.0000435016.83813.aa.
PubMed 24145804Fingerman M, Benonis JG, Martin G. A practical guide to commonly performed ultrasound-guided peripheral-nerve blocks. Curr Opin Anaesthesiol. 2009 Oct;22(5):600-7. doi: 10.1097/ACO.0b013e32832f7643.
PubMed 19606024Baker MD, Gullett JP. Ultrasound-Guided Femoral Nerve Blocks. Pediatr Emerg Care. 2015 Dec;31(12):864-8; quiz 869-71. doi: 10.1097/PEC.0000000000000634.
PubMed 26626896Szucs S, Morau D, Iohom G. Femoral nerve blockade. Med Ultrason. 2010 Jun;12(2):139-44.
PubMed 21173942
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Variation of Femoral Nerve Location in Relation to Femoral Artery - An Ultrasonographic Evaluation
- ClinicalTrials.gov ID
- NCT06026150
- Acronym / sponsor ID
- DSREC-06/2016_03
- Conditions
- Femoral Fractures
- Keywords
- femoral fracture, Ultrasound anatomy of femoral nerve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rashid HospitalOther government
- Study start
- 10 Apr 2016 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 6 Sep 2023 (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.
The goal of this observational study is to learn about the relative position of femoral nerve in relation to the femoral artery in patients scheduled for femoral fractures using ultrasound scanning.
The classical description of femoral nerve is that it lies immediately near to artery, but it is not always true. The nerve lies at a varying distance from the artery.
The main question it aims to answer are:
- Is the age sex and Body Mass Index affect the relationship between femoral artery and nerve?
Detailed description
The femoral nerve block is ideal for surgeries of the femur, knee, or anterior thigh and is often combined with a sciatic nerve block for near complete lower extremity analgesia. The classic teaching is that the femoral nerve lies lateral to femoral artery sandwiched between the fascia iliaca and iliopsoas muscle1.
Aim:
The objective of the study is to find out the anatomical variation in the site of the femoral nerve in relation to the femoral artery, with respect to the age, sex, weight and ethnicity of the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- femoral fracture patients admitted in Rashid hospital and trauma centre Dubai
Key inclusion criteria (1 listed)
- above the age of 18 coming for fixation of femoral fracture
Key exclusion criteria (4 listed)
- below the age of 18
- patient not willing to participate
- patients with neurological illness that hinders from giving a valid consent
- patients with local pathology at inguinal region
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 |
|---|---|---|
| Ultrasound scanning of inguinal area for femoral nerve and arteryultrasound scanning of inguinal region is done in femoral fracture patient to identify femoral artery and nerve | Other | – |
Primary outcome
Variability of anatomical position of Femoral Nerve with respect to Femoral artery - effect of age, sex and BMI
Time frame: From the time the patient is positioned for ultrasound scanning to obtain a clear image of the femoral nerve until the measurement of the distance between the femoral nerve and artery is completed, assessed over a period of up to 6 hours.
After positioning the patients with femoral fracture, ultrasound scanning of femoral nerve is done and the femoral nerve and arteries are identified. The distance between the femoral artery and nerve are measured using ultrasound.
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 6 Sep 2023.
- Background: PubMed 24145804Fanara B, Christophe JL, Boillot A, Tatu L, Jochum D, Henri Y, Berthier F, Samain E. Ultrasound guidance of needle tip position for femoral nerve blockade: an observational study. Eur J Anaesthesiol. 2014 Jan;31(1):23-9. doi: 10.1097/01.EJA.0000435016.83813.aa.
- Background: PubMed 19606024Fingerman M, Benonis JG, Martin G. A practical guide to commonly performed ultrasound-guided peripheral-nerve blocks. Curr Opin Anaesthesiol. 2009 Oct;22(5):600-7. doi: 10.1097/ACO.0b013e32832f7643.
- Background: PubMed 26626896Baker MD, Gullett JP. Ultrasound-Guided Femoral Nerve Blocks. Pediatr Emerg Care. 2015 Dec;31(12):864-8; quiz 869-71. doi: 10.1097/PEC.0000000000000634.
- Background: PubMed 21173942Szucs S, Morau D, Iohom G. Femoral nerve blockade. Med Ultrason. 2010 Jun;12(2):139-44.
- Andrew T. Gray, Adam B. Collins, Ingeborg Schafhalter-Zoppoth, An introduction to femoral nerve and associated lumbar plexus nerve blocks under ultrasonic guidance, Techniques in Regional Anesthesia and Pain Management, Volume 8, Issue 4, 2004, Pages 155Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Fractures, run by Rashid Hospital.
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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Variability of anatomical position of Femoral Nerve with respect to Femoral artery - effect of age, sex and BMI (time frame: From the time the patient is positioned for ultrasound scanning to obtain a clear image of the femoral nerve until the measurement of the distance between the femoral nerve and artery is completed, assessed over a period of up to 6 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 NCT06026150, which also lists 4 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 6 Sep 2023.