<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/NCT04495413</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00008754</org_study_id>
    <nct_id>NCT04495413</nct_id>
  </id_info>
  <brief_title>Assessment of the Effect of Age on Duration of Analgesia From Single-shot Femoral Nerve Blocks</brief_title>
  <official_title>Assessment of the Effect of Age on Duration of Analgesia From Single-shot Femoral Nerve Blocks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</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>
      Cohort study to examine the effect of age on duration of analgesia in patients receiving&#xD;
      single-shot femoral nerve block prior to surgery, by postoperative phone follow-up&#xD;
      questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to find out how differences in age can affect the duration of&#xD;
      pain relief from a femoral nerve block. Complete recovery after leg surgery involves healing&#xD;
      of tissues at the surgical site, recovery of muscle strength and range-of-motion. Some pain&#xD;
      is normally experienced after leg surgery. At the hospital, pain is usually treated with pain&#xD;
      medicines, and/or a nerve block procedure. A nerve block involves injecting a local&#xD;
      anesthetic beside the nerves to numb the nerves that supply feeling to the knee joint and&#xD;
      surrounding tissues. The choice as to whether a participant has a nerve block or not is made&#xD;
      by the participant and their surgeon and is not determined by this research study. The study&#xD;
      aim is to find out how long a nerve block can relieve postsurgical pain, and whether that&#xD;
      duration is affected by the age of the participant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">June 15, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of analgesia</measure>
    <time_frame>From time of block placement to patient to the reported end of analgesic effect, up to 72 hours</time_frame>
    <description>Total duration of analgesia from peripheral femoral nerve block</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Analgesia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult ambulatory surgery patients receiving a single-shot peripheral femoral nerve block&#xD;
        preoperatively as part of their clinical anesthesia care on day-of-surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (age &gt;18 years)&#xD;
&#xD;
          -  American Society of Anesthesiology physical status 1-3&#xD;
&#xD;
          -  Having ambulatory surgery, who have received a single-shot femoral nerve block&#xD;
&#xD;
          -  Able to read and understand English&#xD;
&#xD;
          -  Have access to a phone after surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients (age &lt;18 years)&#xD;
&#xD;
          -  American Society of Anesthesiology physical status &gt;3&#xD;
&#xD;
          -  Unable to read and understand English&#xD;
&#xD;
          -  Unable to have access to a phone after surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vanessa J Loland, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Adam J Claessens, DO</last_name>
    <phone>206-291-7445</phone>
    <email>claessen@uw.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vanessa Loland, MD</last_name>
      <email>vloland@uw.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Vanessa Loland</investigator_full_name>
    <investigator_title>Professor, School of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agnosia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04495413
org study id: STUDY00008754
nct id: NCT04495413
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cohort study to examine the effect of age on duration of analgesia in patients receiving
      single-shot femoral nerve block prior to surgery, by postoperative phone follow-up
      questionnaire.
The purpose of this study is to find out how differences in age can affect the duration of
      pain relief from a femoral nerve block. Complete recovery after leg surgery involves healing
      of tissues at the surgical site, recovery of muscle strength and range-of-motion. Some pain
      is normally experienced after leg surgery. At the hospital, pain is usually treated with pain
      medicines, and/or a nerve block procedure. A nerve block involves injecting a local
      anesthetic beside the nerves to numb the nerves that supply feeling to the knee joint and
      surrounding tissues. The choice as to whether a participant has a nerve block or not is made
      by the participant and their surgeon and is not determined by this research study. The study
      aim is to find out how long a nerve block can relieve postsurgical pain, and whether that
      duration is affected by the age of the participant.
observational model: Cohort
time perspective: Prospective
measure: Duration of analgesia
time frame: From time of block placement to patient to the reported end of analgesic effect, up to 72 hours
description: Total duration of analgesia from peripheral femoral nerve block
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Vanessa J Loland, MD
role: Principal Investigator
affiliation: University of Washington
last name: Adam J Claessens, DO
phone: 206-291-7445
email: claessen@uw.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Vanessa Loland
investigator title: Professor, School of Medicine
mesh term: Agnosia