<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/NCT02996994</url>
  </required_header>
  <id_info>
    <org_study_id>16-093</org_study_id>
    <nct_id>NCT02996994</nct_id>
  </id_info>
  <brief_title>Predictors of Postoperative Pain</brief_title>
  <official_title>Predictors of Postoperative Pain in Urogynecologic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TriHealth Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TriHealth Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a retrospective chart review using TriHealth Electronic Privacy Identification Center&#xD;
      (EPIC) and previously developed databases for TriHealth Institutional Review Board (IRB)&#xD;
      approved research studies within the Division of Urogynecology and Reconstructive Pelvic&#xD;
      Surgery to determine the predictors of postoperative pain specific to the urogynecologic&#xD;
      patient population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pain remains the most important consideration for both patients and surgeons.&#xD;
      Therefore, there has been much attention brought toward investigating predictive factors of&#xD;
      postoperative pain. A systematic review of 48 eligible studies with 23,037 patients showed&#xD;
      preexisting pain, anxiety, age, and type of surgery are the four most significant predictive&#xD;
      factors for the intensity of postoperative pain. However, this paper evaluated all types of&#xD;
      surgical approaches. More recently, a prospective observational study showed that&#xD;
      preoperative State Trait Anxiety Inventory (STAI) and Numerical Rating Scales (NRS) for&#xD;
      anxiety and pain expectations are independent predictors of pain and morphine consumption&#xD;
      following abdominal hysterectomy. To date, little is known about the predictive factors of&#xD;
      postoperative pain in the urogynecologic patient population.&#xD;
&#xD;
      The purpose of this study is to determine the predictors of postoperative pain specific to&#xD;
      the urogynecologic patient population. We aim to investigate the relationship between&#xD;
      perioperative factors (such as demographics and medical history) and postoperative pain&#xD;
      scores on postoperative day 1 with patients who have undergone urogynecologic surgery,&#xD;
      specifically vaginal reconstruction for pelvic organ prolapse.&#xD;
&#xD;
      This information would not only fill a gap in knowledge, but would also allow us to counsel&#xD;
      our patients more accurately in regards to postoperative expectations. Furthermore, if we&#xD;
      find any positive correlation between modifiable perioperative factors and postoperative pain&#xD;
      scores, we may be able to minimize these effects in future surgical cases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS) Pain Score</measure>
    <time_frame>postoperative day 1 (POD1)</time_frame>
    <description>VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.</description>
  </primary_outcome>
  <enrollment type="Actual">364</enrollment>
  <condition>Postoperative Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All participants of previous TriHealth IRB-approved research studies within the Division of&#xD;
        Urogynecology and Reconstructive Pelvic Surgery that incorporated assessment of&#xD;
        postoperative pain as part of the data collection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant in one of six research studies previously performed by the Division of&#xD;
             Urogynecology and Pelvic Reconstructive Surgery (#13090, #13072, #12136, #12132,&#xD;
             #10072, or #09001)&#xD;
&#xD;
          -  Postoperative pain scoring data complete and available&#xD;
&#xD;
          -  Vaginal reconstructive surgery as primary treatment&#xD;
&#xD;
          -  General anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incomplete or unavailable postoperative pain scoring&#xD;
&#xD;
          -  Robotic sacrocolpopexy patients will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel Pauls, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TriHealth - Cincinnati Urogynecology Associates</affiliation>
  </overall_official>
  <reference>
    <citation>Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.</citation>
    <PMID>19672167</PMID>
  </reference>
  <reference>
    <citation>Aouad MT, Kanazi GE, Malek K, Tamim H, Zahreddine L, Kaddoum RN. Predictors of postoperative pain and analgesic requirements following abdominal hysterectomy: an observational study. J Anesth. 2016 Feb;30(1):72-9. doi: 10.1007/s00540-015-2090-0. Epub 2015 Oct 24.</citation>
    <PMID>26499321</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <results_first_submitted>October 19, 2022</results_first_submitted>
  <results_first_submitted_qc>October 19, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 31, 2023</results_first_posted>
  <last_update_submitted>October 19, 2022</last_update_submitted>
  <last_update_submitted_qc>October 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 28, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT02996994/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Reconstructive Surgery</title>
          <description>Eligible trials enrolled subjects undergoing vaginal reconstructive surgery for pelvic organ prolapse from 2009 to 2015.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="364"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="364"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Reconstructive Surgery</title>
          <description>Eligible trials enrolled subjects undergoing vaginal reconstructive surgery for pelvic organ prolapse from 2009 to 2015.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="364"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.44" spread="11.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="364"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="351"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="364"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Visual Analog Scale (VAS) Pain Score</title>
        <description>VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.</description>
        <time_frame>postoperative day 1 (POD1)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Reconstructive Surgery</title>
            <description>Eligible trials enrolled subjects undergoing vaginal reconstructive surgery for pelvic organ prolapse from 2009 to 2015.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analog Scale (VAS) Pain Score</title>
          <description>VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="364"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.16" spread="24.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From time of surgery to 12 weeks after surgery</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Reconstructive Surgery</title>
          <description>Eligible trials enrolled subjects undergoing vaginal reconstructive surgery for pelvic organ prolapse from 2009 to 2015.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="364"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="364"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Rachel Pauls</name_or_title>
      <organization>TriHealth Inc.</organization>
      <phone>513-463-4300</phone>
      <email>Rachel_Pauls@trihealth.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02996994
org study id: 16-093
nct id: NCT02996994
lead sponsor: 
has dmc: No
This is a retrospective chart review using TriHealth Electronic Privacy Identification Center
      (EPIC) and previously developed databases for TriHealth Institutional Review Board (IRB)
      approved research studies within the Division of Urogynecology and Reconstructive Pelvic
      Surgery to determine the predictors of postoperative pain specific to the urogynecologic
      patient population.
Postoperative pain remains the most important consideration for both patients and surgeons.
      Therefore, there has been much attention brought toward investigating predictive factors of
      postoperative pain. A systematic review of 48 eligible studies with 23,037 patients showed
      preexisting pain, anxiety, age, and type of surgery are the four most significant predictive
      factors for the intensity of postoperative pain. However, this paper evaluated all types of
      surgical approaches. More recently, a prospective observational study showed that
      preoperative State Trait Anxiety Inventory (STAI) and Numerical Rating Scales (NRS) for
      anxiety and pain expectations are independent predictors of pain and morphine consumption
      following abdominal hysterectomy. To date, little is known about the predictive factors of
      postoperative pain in the urogynecologic patient population.

      The purpose of this study is to determine the predictors of postoperative pain specific to
      the urogynecologic patient population. We aim to investigate the relationship between
      perioperative factors (such as demographics and medical history) and postoperative pain
      scores on postoperative day 1 with patients who have undergone urogynecologic surgery,
      specifically vaginal reconstruction for pelvic organ prolapse.

      This information would not only fill a gap in knowledge, but would also allow us to counsel
      our patients more accurately in regards to postoperative expectations. Furthermore, if we
      find any positive correlation between modifiable perioperative factors and postoperative pain
      scores, we may be able to minimize these effects in future surgical cases.
observational model: Cohort
time perspective: Retrospective
measure: Visual Analog Scale (VAS) Pain Score
time frame: postoperative day 1 (POD1)
description: VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rachel Pauls, MD
role: Principal Investigator
affiliation: TriHealth - Cincinnati Urogynecology Associates
citation: Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
PMID: 19672167
citation: Aouad MT, Kanazi GE, Malek K, Tamim H, Zahreddine L, Kaddoum RN. Predictors of postoperative pain and analgesic requirements following abdominal hysterectomy: an observational study. J Anesth. 2016 Feb;30(1):72-9. doi: 10.1007/s00540-015-2090-0. Epub 2015 Oct 24.
PMID: 26499321
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 