<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/NCT03307525</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00026402</org_study_id>
    <nct_id>NCT03307525</nct_id>
  </id_info>
  <brief_title>Pain After Breast Surgery</brief_title>
  <official_title>A Pilot Study Assessing the Correlation of Preoperative Sensory Testing and Genetic Polymorphisms With Acute and Persistent Postoperative Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Society for Ambulatory Anesthesia (SAMBA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</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>
      This is a pilot observational study assessing various predictors for acute pain and&#xD;
      persistent pain following breast surgery for cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 20, 2012</start_date>
  <completion_date type="Actual">December 22, 2015</completion_date>
  <primary_completion_date type="Actual">December 22, 2015</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>Acute Pain</measure>
    <time_frame>72 hours after surgery</time_frame>
    <description>Maximum pain score reported postoperatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Persistent Pain</measure>
    <time_frame>More than 6 months after surgery</time_frame>
    <description>pain score ≥ 3 or pain that impacts daily life as indicated by a score &gt;0 on any of the 7 daily activity questions more than 6 months after surgery</description>
  </secondary_outcome>
  <enrollment type="Actual">141</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Women undergoing elective breast cancer surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking undergoing elective breast cancer surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with recurrent cancer, metastasis, and previous breast surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03307525
org study id: Pro00026402
nct id: NCT03307525
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a pilot observational study assessing various predictors for acute pain and
      persistent pain following breast surgery for cancer.
observational model: Cohort
time perspective: Prospective
measure: Acute Pain
time frame: 72 hours after surgery
description: Maximum pain score reported postoperatively
measure: Persistent Pain
time frame: More than 6 months after surgery
description: pain score ≥ 3 or pain that impacts daily life as indicated by a score >0 on any of the 7 daily activity questions more than 6 months after surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor