<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/NCT03020563</url>
  </required_header>
  <id_info>
    <org_study_id>1611M99381</org_study_id>
    <nct_id>NCT03020563</nct_id>
  </id_info>
  <brief_title>Does Liposomal Bupivacaine Provide Improved Pain Management for ORIF of Midshaft Clavicle Fractures?</brief_title>
  <official_title>Does Liposomal Bupivacaine Provide Improved Pain Management for ORIF of Midshaft Clavicle Fractures?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine whether liposomal bupivacaine wound infiltration decreases pain scores and&#xD;
      narcotic use when compared to bupivacaine alone after open reduction internal fixation of&#xD;
      midshaft clavicle fractures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no longer necessary&#xD;
  </why_stopped>
  <start_date type="Actual">August 23, 2017</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Pain Scale Averages between the two treatments</measure>
    <time_frame>72 hours post surgery</time_frame>
    <description>Scale is based on 1-10 with 1 being the lowest pain and 10 being the highest pain.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Clavicle Fracture</condition>
  <arm_group>
    <arm_group_label>Liposomal Bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Time release Bupivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivacaine</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Immediate Acting Bupivacaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Liposomal Bupivacaine</intervention_name>
    <description>Liposomal Bupivacaine</description>
    <arm_group_label>Liposomal Bupivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Bupivacaine</description>
    <arm_group_label>Bupivacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mid-shaft Clavicle Fracture treated with ORIF&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to be contacted for 72 hours post surgery&#xD;
&#xD;
          -  Other concurrent surgical procedures&#xD;
&#xD;
          -  Chronic narcotic user&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>October 11, 2018</last_update_submitted>
  <last_update_submitted_qc>October 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <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/NCT03020563
org study id: 1611M99381
nct id: NCT03020563
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
To determine whether liposomal bupivacaine wound infiltration decreases pain scores and
      narcotic use when compared to bupivacaine alone after open reduction internal fixation of
      midshaft clavicle fractures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Analogue Pain Scale Averages between the two treatments
time frame: 72 hours post surgery
description: Scale is based on 1-10 with 1 being the lowest pain and 10 being the highest pain.
arm group label: Liposomal Bupivacaine
arm group type: Active Comparator
description: Time release Bupivacaine
arm group label: Bupivacaine
arm group type: Placebo Comparator
description: Immediate Acting Bupivacaine
intervention type: Drug
intervention name: Liposomal Bupivacaine
description: Liposomal Bupivacaine
arm group label: Liposomal Bupivacaine
intervention type: Drug
intervention name: Bupivacaine
description: Bupivacaine
arm group label: Bupivacaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Bupivacaine
sharing ipd: No