<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/NCT03008564</url>
  </required_header>
  <id_info>
    <org_study_id>201612345</org_study_id>
    <nct_id>NCT03008564</nct_id>
  </id_info>
  <brief_title>Adductor Canal Block Ultrasound Anatomy in Volunteers</brief_title>
  <official_title>Determining The Location and Ultrasound Anatomy of Two Previously Described Adductor Canal Block Approaches in Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There has been dispute about the location at which the adductor canal block should be&#xD;
      performed (3-6). Two Common approaches have been used for ultrasound guided adductor canal&#xD;
      blocks with the 'point of entry' being:&#xD;
&#xD;
        1. Point A: midway point between the ASIS and base of patella&#xD;
&#xD;
        2. Point B: Point which is 2-3 cm proximal to the site where the femoral artery becomes the&#xD;
           popliteal artery as it traverses away from the sartorius muscle towards the femur at the&#xD;
           adductor hiatus (2)&#xD;
&#xD;
      We want to determine ultrasound anatomy in healthy volunteers by:&#xD;
&#xD;
        1. Measuring the distance between Point A and Point B&#xD;
&#xD;
        2. Studying the ultrasound anatomy at Point A and B - Determine their location with respect&#xD;
           to the adductor canal and femoral triangle.&#xD;
&#xD;
      This will allow us to determine which is the best site for performing an adductor canal block&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is important to answer the primary question because of the variable length of the adductor&#xD;
      canal and we would like to determine the optimal position to perform the adductor canal&#xD;
      block.&#xD;
&#xD;
      The adductor canal typically contains the saphenous nerve, nerve to vastus medialis muscle&#xD;
      and on occasion, the obturator nerve (1). The roof of adductor canal is the vasto-adductor&#xD;
      membrane and its length is reported to range from 5.5 cm to 15 cm with a mean of 7.6 cm2 and&#xD;
      would suggest the length of the AC is variable. We would like to determine the length of the&#xD;
      AC with the use of ultrasound. The AC would be determined to begin at the apex of the femoral&#xD;
      triangle and end just proximal to the adductor hiatus. The length and location of the AC&#xD;
      would be important to characterize as the volume of local anesthetic used and associated&#xD;
      quadriceps weakness could be of significance in a shorter AC.&#xD;
&#xD;
      There has been dispute about the location at which the adductor canal block should be&#xD;
      performed (3-6). Point A has been disputed to be within the femoral triangle and would&#xD;
      therefore be a femoral nerve block as suggested by a small body of evidence (4-5).&#xD;
      Clinically, it is unclear if there is a difference between quadriceps muscle weakness between&#xD;
      the two approaches although it could be hypothesized placing a block at point A would lead to&#xD;
      more quadriceps muscle weakness. With information gathered from this study, we plan to&#xD;
      perform a clinical study by performing the nerve blocks at these two points with different&#xD;
      volumes of local anesthetic and compare the amount analgesia and motor weakness between the&#xD;
      two different approaches.&#xD;
&#xD;
      60 Volunteers (30 male and 30 female) aged between 18 to 75 years with a body mass index of&#xD;
      18 to 35 kg/m2 will be included in this study. Volunteers with previous surgery or&#xD;
      deformities of the lower extremity will be excluded from the study&#xD;
&#xD;
      This is an observational study without a control group. Several reference points will be&#xD;
      marked by anatomical landmarks and/or ultrasound:&#xD;
&#xD;
      A. the anterior superior iliac spine (landmark); B. the base of the patella (landmark); C.&#xD;
      apex of femoral triangle (ultrasound); and D. distal most portion of adductor canal (Point B&#xD;
      described earlier; ultrasound).&#xD;
&#xD;
      The primary outcome measure we are looking at is the distance between Point A and Point B.&#xD;
&#xD;
      We also plan to measure the distance (in centimeters) from:&#xD;
&#xD;
        1. Base of patella to Point A&#xD;
&#xD;
        2. Base of patella to Point B&#xD;
&#xD;
        3. Apex of the femoral triangle&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">June 16, 2017</completion_date>
  <primary_completion_date type="Actual">June 16, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement 1</measure>
    <time_frame>One time assessment done during Ultrasound scanning of the lower extremity</time_frame>
    <description>The distance in cm between Point A and Point B</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement 2</measure>
    <time_frame>One time assessment done during Ultrasound scanning of the lower extremity</time_frame>
    <description>The distance in cm between Point A and base of patella</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement 3</measure>
    <time_frame>One time assessment done during Ultrasound scanning of the lower extremity</time_frame>
    <description>The distance in cm between Point B and base of patella</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement 4</measure>
    <time_frame>One time assessment done during Ultrasound scanning of the lower extremity</time_frame>
    <description>The distance in cm between Apex of femoral triangle and base of patella</description>
  </secondary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Adductor Canal Block</condition>
  <condition>Postop Analgesia for Knee</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound scanning of the lower limb in volunteers</intervention_name>
    <description>Several reference points will be marked by anatomical landmarks and/or ultrasound: the anterior superior iliac spine; base of patella; apex of the femoral triangle A measuring tape will be used to measure the anterior superior iliac spine (landmark); the base of the patella (landmark); apex of femoral triangle (ultrasound); and distal most portion of adductor canal (Point B described earlier; ultrasound). We will then measure the ASIS to: 1) base of patella; 2) apex of femoral triangle; and 3) Point B. We will repeat the same procedure on the opposite leg. Once complete, the volunteer will be allowed to dress and leave. The procedure should take approximately 10-20 minutes for each volunteer. The following things will be recorded for each subject:&#xD;
Age&#xD;
Gender&#xD;
Weight&#xD;
Height&#xD;
BMI&#xD;
Distance of ASIS to base of patella&#xD;
Distance of Point A to base of patella&#xD;
Distance of Point B to base of patella&#xD;
Distance of apex of femoral triangle to base of patella</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We aim to recruit volunteers who principally are healthcare employees at UIHC who mainly&#xD;
        work in the Main Operating Rooms and Ambulatory Surgical Center Operating Rooms, mainly due&#xD;
        to ease of access to ultrasonographic equipment. The subjects include anesthesiologists,&#xD;
        certified registered nurse anesthetists, residents, interns, nurses, volunteers,&#xD;
        technicians, administrative staff and other members of staff working in these areas.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18-75 years, body mass index 18-35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no previous surgery or complaints from the lower extremity region&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amanda Yap, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>319-356-1616</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Defining adductor canal block. Reg Anesth Pain Med. 2014 May-Jun;39(3):253-4. doi: 10.1097/AAP.0000000000000052. No abstract available.</citation>
    <PMID>24747312</PMID>
  </reference>
  <reference>
    <citation>Tubbs RS, Loukas M, Shoja MM, Apaydin N, Oakes WJ, Salter EG. Anatomy and potential clinical significance of the vastoadductor membrane. Surg Radiol Anat. 2007 Oct;29(7):569-73. doi: 10.1007/s00276-007-0230-4. Epub 2007 Jul 7.</citation>
    <PMID>17618402</PMID>
  </reference>
  <reference>
    <citation>Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.</citation>
    <PMID>24121608</PMID>
  </reference>
  <reference>
    <citation>Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Redefining the adductor canal block. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):442-3. doi: 10.1097/AAP.0000000000000119. No abstract available.</citation>
    <PMID>25140514</PMID>
  </reference>
  <reference>
    <citation>Bendtsen TF, Moriggl B, Chan V, Borglum J. Basic Topography of the Saphenous Nerve in the Femoral Triangle and the Adductor Canal. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):391-2. doi: 10.1097/AAP.0000000000000261. No abstract available.</citation>
    <PMID>26079358</PMID>
  </reference>
  <reference>
    <citation>Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.</citation>
    <PMID>19916251</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 5, 2017</last_update_submitted>
  <last_update_submitted_qc>December 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Yatish Siddapura Ranganath</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03008564
org study id: 201612345
nct id: NCT03008564
lead sponsor: 
has dmc: No
There has been dispute about the location at which the adductor canal block should be
      performed (3-6). Two Common approaches have been used for ultrasound guided adductor canal
      blocks with the 'point of entry' being:

        1. Point A: midway point between the ASIS and base of patella

        2. Point B: Point which is 2-3 cm proximal to the site where the femoral artery becomes the
           popliteal artery as it traverses away from the sartorius muscle towards the femur at the
           adductor hiatus (2)

      We want to determine ultrasound anatomy in healthy volunteers by:

        1. Measuring the distance between Point A and Point B

        2. Studying the ultrasound anatomy at Point A and B - Determine their location with respect
           to the adductor canal and femoral triangle.

      This will allow us to determine which is the best site for performing an adductor canal block
It is important to answer the primary question because of the variable length of the adductor
      canal and we would like to determine the optimal position to perform the adductor canal
      block.

      The adductor canal typically contains the saphenous nerve, nerve to vastus medialis muscle
      and on occasion, the obturator nerve (1). The roof of adductor canal is the vasto-adductor
      membrane and its length is reported to range from 5.5 cm to 15 cm with a mean of 7.6 cm2 and
      would suggest the length of the AC is variable. We would like to determine the length of the
      AC with the use of ultrasound. The AC would be determined to begin at the apex of the femoral
      triangle and end just proximal to the adductor hiatus. The length and location of the AC
      would be important to characterize as the volume of local anesthetic used and associated
      quadriceps weakness could be of significance in a shorter AC.

      There has been dispute about the location at which the adductor canal block should be
      performed (3-6). Point A has been disputed to be within the femoral triangle and would
      therefore be a femoral nerve block as suggested by a small body of evidence (4-5).
      Clinically, it is unclear if there is a difference between quadriceps muscle weakness between
      the two approaches although it could be hypothesized placing a block at point A would lead to
      more quadriceps muscle weakness. With information gathered from this study, we plan to
      perform a clinical study by performing the nerve blocks at these two points with different
      volumes of local anesthetic and compare the amount analgesia and motor weakness between the
      two different approaches.

      60 Volunteers (30 male and 30 female) aged between 18 to 75 years with a body mass index of
      18 to 35 kg/m2 will be included in this study. Volunteers with previous surgery or
      deformities of the lower extremity will be excluded from the study

      This is an observational study without a control group. Several reference points will be
      marked by anatomical landmarks and/or ultrasound:

      A. the anterior superior iliac spine (landmark); B. the base of the patella (landmark); C.
      apex of femoral triangle (ultrasound); and D. distal most portion of adductor canal (Point B
      described earlier; ultrasound).

      The primary outcome measure we are looking at is the distance between Point A and Point B.

      We also plan to measure the distance (in centimeters) from:

        1. Base of patella to Point A

        2. Base of patella to Point B

        3. Apex of the femoral triangle
observational model: Case-Only
time perspective: Prospective
measure: Measurement 1
time frame: One time assessment done during Ultrasound scanning of the lower extremity
description: The distance in cm between Point A and Point B
measure: Measurement 2
time frame: One time assessment done during Ultrasound scanning of the lower extremity
description: The distance in cm between Point A and base of patella
measure: Measurement 3
time frame: One time assessment done during Ultrasound scanning of the lower extremity
description: The distance in cm between Point B and base of patella
measure: Measurement 4
time frame: One time assessment done during Ultrasound scanning of the lower extremity
description: The distance in cm between Apex of femoral triangle and base of patella
intervention type: Other
intervention name: Ultrasound scanning of the lower limb in volunteers
description: Several reference points will be marked by anatomical landmarks and/or ultrasound: the anterior superior iliac spine; base of patella; apex of the femoral triangle A measuring tape will be used to measure the anterior superior iliac spine (landmark); the base of the patella (landmark); apex of femoral triangle (ultrasound); and distal most portion of adductor canal (Point B described earlier; ultrasound). We will then measure the ASIS to: 1) base of patella; 2) apex of femoral triangle; and 3) Point B. We will repeat the same procedure on the opposite leg. Once complete, the volunteer will be allowed to dress and leave. The procedure should take approximately 10-20 minutes for each volunteer. The following things will be recorded for each subject:
Age
Gender
Weight
Height
BMI
Distance of ASIS to base of patella
Distance of Point A to base of patella
Distance of Point B to base of patella
Distance of apex of femoral triangle to base of patella
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amanda Yap, MBBS
role: Principal Investigator
affiliation: 319-356-1616
facility: 
country: United States
citation: Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Defining adductor canal block. Reg Anesth Pain Med. 2014 May-Jun;39(3):253-4. doi: 10.1097/AAP.0000000000000052. No abstract available.
PMID: 24747312
citation: Tubbs RS, Loukas M, Shoja MM, Apaydin N, Oakes WJ, Salter EG. Anatomy and potential clinical significance of the vastoadductor membrane. Surg Radiol Anat. 2007 Oct;29(7):569-73. doi: 10.1007/s00276-007-0230-4. Epub 2007 Jul 7.
PMID: 17618402
citation: Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.
PMID: 24121608
citation: Bendtsen TF, Moriggl B, Chan V, Pedersen EM, Borglum J. Redefining the adductor canal block. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):442-3. doi: 10.1097/AAP.0000000000000119. No abstract available.
PMID: 25140514
citation: Bendtsen TF, Moriggl B, Chan V, Borglum J. Basic Topography of the Saphenous Nerve in the Femoral Triangle and the Adductor Canal. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):391-2. doi: 10.1097/AAP.0000000000000261. No abstract available.
PMID: 26079358
citation: Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.
PMID: 19916251
responsible party type: Principal Investigator
investigator affiliation: University of Iowa
investigator full name: Yatish Siddapura Ranganath
investigator title: Clinical Assistant Professor
sharing ipd: No