xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06026150</url>
    </required_header>
    <id_info>
      <org_study_id>DSREC-06/2016_03</org_study_id>
      <nct_id>NCT06026150</nct_id>
    </id_info>
    <brief_title>Anatomical Variations of Femoral Nerve Location in Relation to Femoral Artery</brief_title>
    <official_title>Anatomical Variation of Femoral Nerve Location in Relation to Femoral Artery - An Ultrasonographic Evaluation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rashid Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rashid Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to learn about the relative position of femoral nerve&#xD;
        in relation to the femoral artery in patients scheduled for femoral fractures using&#xD;
        ultrasound scanning.&#xD;
  &#xD;
        The classical description of femoral nerve is that it lies immediately near to artery, but it&#xD;
        is not always true. The nerve lies at a varying distance from the artery.&#xD;
  &#xD;
        The main question it aims to answer are:&#xD;
  &#xD;
        • Is the age sex and Body Mass Index affect the relationship between femoral artery and&#xD;
        nerve?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The femoral nerve block is ideal for surgeries of the femur, knee, or anterior thigh and is&#xD;
        often combined with a sciatic nerve block for near complete lower extremity analgesia. The&#xD;
        classic teaching is that the femoral nerve lies lateral to femoral artery sandwiched between&#xD;
        the fascia iliaca and iliopsoas muscle1.&#xD;
  &#xD;
        Aim:&#xD;
  &#xD;
        The objective of the study is to find out the anatomical variation in the site of the femoral&#xD;
        nerve in relation to the femoral artery, with respect to the age, sex, weight and ethnicity&#xD;
        of the patient.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 10, 2016</start_date>
    <completion_date type="Actual">August 15, 2021</completion_date>
    <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Variability of anatomical position of Femoral Nerve with respect to Femoral artery - effect of age, sex and BMI</measure>
      <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.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <enrollment type="Actual">200</enrollment>
    <condition>Femoral Fractures</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Ultrasound scanning of inguinal area for femoral nerve and artery</intervention_name>
      <description>ultrasound scanning of inguinal region is done in femoral fracture patient to identify femoral artery and nerve</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          femoral fracture patients admitted in Rashid hospital and trauma centre Dubai&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  above the age of 18 coming for fixation of femoral fracture&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  below the age of 18&#xD;
  &#xD;
            -  patient not willing to participate&#xD;
  &#xD;
            -  patients with neurological illness that hinders from giving a valid consent&#xD;
  &#xD;
            -  patients with local pathology at inguinal region&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <link>
      <url>https://doi.org/10.1053/j.trap.2004.10.004</url>
      <description>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 155</description>
    </link>
    <link>
      <url>https://accessanesthesiology.mhmedical.com/content.aspx?bookid=3074&amp;sectionid=256635254</url>
      <description>Femoral nerve block. Hadzic A(Ed.), (2021). Hadzic's Peripheral Nerve Blocks and Anatomy for Ultrasound-Guided Regional Anesthesia, 3e. McGraw Hill.</description>
    </link>
    <reference>
      <citation>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.</citation>
      <PMID>24145804</PMID>
    </reference>
    <reference>
      <citation>Fingerman 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.</citation>
      <PMID>19606024</PMID>
    </reference>
    <reference>
      <citation>Baker 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.</citation>
      <PMID>26626896</PMID>
    </reference>
    <reference>
      <citation>Szucs S, Morau D, Iohom G. Femoral nerve blockade. Med Ultrason. 2010 Jun;12(2):139-44.</citation>
      <PMID>21173942</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Rashid Hospital</investigator_affiliation>
      <investigator_full_name>Kurian Palavilayil Thomas Vaidyan</investigator_full_name>
      <investigator_title>Senior Specialist, Dept of Anesthesiology</investigator_title>
    </responsible_party>
    <keyword>femoral fracture</keyword>
    <keyword>Ultrasound anatomy of femoral nerve</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Femoral Fractures</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>March 20, 2016</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT06026150/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06026150
  org study id: DSREC-06/2016_03
  nct id: NCT06026150
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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?
  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.
  observational model: Cohort
  time perspective: Cross-Sectional
  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.
  description: 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.
  intervention type: Other
  intervention name: Ultrasound scanning of inguinal area for femoral nerve and artery
  description: ultrasound scanning of inguinal region is done in femoral fracture patient to identify femoral artery and nerve
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  url: https://doi.org/10.1053/j.trap.2004.10.004
  description: 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 155
  url: https://accessanesthesiology.mhmedical.com/content.aspx?bookid=3074&sectionid=256635254
  description: Femoral nerve block. Hadzic A(Ed.), (2021). Hadzic's Peripheral Nerve Blocks and Anatomy for Ultrasound-Guided Regional Anesthesia, 3e. McGraw Hill.
  citation: 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.
  PMID: 24145804
  citation: Fingerman 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.
  PMID: 19606024
  citation: Baker 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.
  PMID: 26626896
  citation: Szucs S, Morau D, Iohom G. Femoral nerve blockade. Med Ultrason. 2010 Jun;12(2):139-44.
  PMID: 21173942
  responsible party type: Principal Investigator
  investigator affiliation: Rashid Hospital
  investigator full name: Kurian Palavilayil Thomas Vaidyan
  investigator title: Senior Specialist, Dept of Anesthesiology
  mesh term: Femoral Fractures
  sharing ipd: Undecided
  provided document: 