<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/NCT04494880</url>
  </required_header>
  <id_info>
    <org_study_id>1618426-3</org_study_id>
    <nct_id>NCT04494880</nct_id>
  </id_info>
  <brief_title>Marcaine Post-Operative Pain Study</brief_title>
  <official_title>Marcaine Post-Operative Pain Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York - Upstate Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York - Upstate Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study examines the efficacy of Marcaine in post-operative pain reduction for patients&#xD;
      receiving breast reduction surgery. Patients who consent will be randomized to which breast&#xD;
      receives a Marcaine injection and the other breast will have saline injected. Pain will be&#xD;
      assessed one time post-operatively using a 1-10 pain scale.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 9, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</primary_completion_date>
  <phase>Early Phase 1</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Marcaine Use in Breast Reconstruction: Post-Operative Pain Scale Assessment per Breast</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Minimum score: 1 (minimal pain), Maximum score: 10 (worst pain possible/worst outcome), higher pain scores associated with worse outcomes</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Effect of Drug</condition>
  <arm_group>
    <arm_group_label>Treatment Group (Marcaine 1 Breast)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Marcaine will be injected into one randomized breast and saline into the other in the treatment group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group (Marcaine 2 Breasts)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Marcaine will be injected into both breasts as is currently the standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine Injection</intervention_name>
    <description>Treatment group receives Marcaine (Bupivacaine) injected into one breast following breast reduction surgery and a saline injection in the other group.</description>
    <arm_group_label>Treatment Group (Marcaine 1 Breast)</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be receiving bilateral breast reduction surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unilateral breast reduction surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prashant Upadhyaya, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SUNY Upstate Medical University - Syracuse, NY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Upstate University Hospital</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>May 9, 2022</last_update_submitted>
  <last_update_submitted_qc>May 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2022</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>Pain, Postoperative</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/NCT04494880
org study id: 1618426-3
nct id: NCT04494880
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The study examines the efficacy of Marcaine in post-operative pain reduction for patients
      receiving breast reduction surgery. Patients who consent will be randomized to which breast
      receives a Marcaine injection and the other breast will have saline injected. Pain will be
      assessed one time post-operatively using a 1-10 pain scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Marcaine Use in Breast Reconstruction: Post-Operative Pain Scale Assessment per Breast
time frame: through study completion, an average of 1 year
description: Minimum score: 1 (minimal pain), Maximum score: 10 (worst pain possible/worst outcome), higher pain scores associated with worse outcomes
arm group label: Treatment Group (Marcaine 1 Breast)
arm group type: Experimental
description: Marcaine will be injected into one randomized breast and saline into the other in the treatment group.
arm group label: Control Group (Marcaine 2 Breasts)
arm group type: No Intervention
description: Marcaine will be injected into both breasts as is currently the standard of care.
intervention type: Drug
intervention name: Bupivacaine Injection
description: Treatment group receives Marcaine (Bupivacaine) injected into one breast following breast reduction surgery and a saline injection in the other group.
arm group label: Treatment Group (Marcaine 1 Breast)
other name: Marcaine
criteria: 
gender: All
minimum age: N/A
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Prashant Upadhyaya, MD
role: Principal Investigator
affiliation: SUNY Upstate Medical University - Syracuse, NY
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Bupivacaine
sharing ipd: No