<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/NCT03810235</url>
  </required_header>
  <id_info>
    <org_study_id>Meriter IRB 2018-015</org_study_id>
    <secondary_id>A532860</secondary_id>
    <secondary_id>SMPH/OBSTET &amp; GYNECOL/OBSTET</secondary_id>
    <secondary_id>2019-0139</secondary_id>
    <nct_id>NCT03810235</nct_id>
  </id_info>
  <brief_title>The OBstetric Lidocaine Patch (OBLido) Trial</brief_title>
  <acronym>OBLido</acronym>
  <official_title>Transdermal Lidocaine Patch for Post-Cesarean Pain Control for Women With Obesity: a Single-blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <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>
      This study will be a single-center, single blind, randomized controlled trial. The study will&#xD;
      be conducted at UnityPoint-Health Meriter Hospital under investigators from the University of&#xD;
      Wisconsin-Madison. Obstetric patients with prepregnancy obesity undergoing a Cesarean&#xD;
      delivery at UnityPoint-Health Meriter will be eligible.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine whether transdermal lidocaine administered at the&#xD;
      time of Cesarean delivery and for 12 hours postoperatively will reduce the total dose of&#xD;
      opioids received. Our hypothesis is that a lidocaine patch will reduce the total dose of&#xD;
      opioids received in the immediate 24 hours post-delivery. Secondary outcomes will include&#xD;
      patient self-reported pain scores, patient-reported incidence of side effects, such as&#xD;
      pruritis, development of objective complications, such as serious skin reactions (examples&#xD;
      are acute generalized exanthematous pustolosis, Stevens-Johnson syndrome, and toxic epidermal&#xD;
      necrolysis), hypersensitivity, nausea, and nervousness. Other outcomes collected will include&#xD;
      length of stay, time to first rescue analgesic medication, total dose of opioids in 48 hours,&#xD;
      use of supplemental oxygen during hospitalization, total dose of opioids during&#xD;
      hospitalization, breastfeeding rates, both exclusive and in combination with formula use,&#xD;
      amount of opioid prescribed at discharge and whether refills were requested or administered,&#xD;
      rates of chronic pain at six weeks postpartum, and six week Edinburgh Depression Screen&#xD;
      scores. Neonatal outcomes such as five-minute Apgar scores and development of adverse&#xD;
      outcomes will also be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 9, 2019</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>
    <intervention_model_description>single-center, single blind, randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Dose of Opioids Received in the First 24 Hours Following Cesarean</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>The total dose of opioids received in the first 24 hours following Cesarean delivery measured as oral morphine equivalents. This total dose will be calculated for every subject in the study, and the average and standard deviation (or appropriate non-parametric values if the data is not normally distributed) will be compared between the subjects randomized to the intervention arm and the placebo arm of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative Pain Score at 24 Hours Post-operatively</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>The post-operative pain score at 24 hours post-operatively will be measured using the numeric rating scale (NRS), wherein subjects rate pain on a 0-10 scale (10 meaning the most pain and 0 meaning no pain). The median NRS score at 24 hours will be compared between the two groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Opioid-related Side Effects</measure>
    <time_frame>up to 6 weeks postpartum</time_frame>
    <description>Patient-reported opioid-related side effects include pruritis, constipation, nausea, and mental clouding.&#xD;
Definition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous &quot;Yes/No&quot; outcomes for each side effect)</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Complications of Lidocaine Use</measure>
    <time_frame>up to 6 weeks postpartum</time_frame>
    <description>Complications of lidocaine use include local burning, nausea, dizziness, drowsiness, serious skin reactions such as blistering, confusion, blurred vision, ringing in the ears, and allergies and hypersensitivities.&#xD;
Definition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous &quot;Yes/No&quot; outcomes for each side effect)</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>up to 120 hours</time_frame>
    <description>Measured in hours from admission to time of discharge This will be measured in hours from the documented time of admission until discharge</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to First Rescue Opioid Analgesic Medication</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>Measured in minutes from arrival in the post-anesthesia care unit (PACU) until the first as needed opioid dose is administered. This will be recorded in minutes from the time of the surgery completion (surgery end time) until the first opioid analgesic medication is administered. Data in table is noted in hours.</description>
  </other_outcome>
  <other_outcome>
    <measure>Total Dose of Opioids Used in the First 48 Hours Post-operatively</measure>
    <time_frame>up to 48 hours</time_frame>
    <description>All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received in 48 hours following surgery calculated as oral morphine equivalents</description>
  </other_outcome>
  <other_outcome>
    <measure>Total Dose of Opioids During the Whole Hospitalization.</measure>
    <time_frame>up to 120 hours</time_frame>
    <description>All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received during the hospitalization (following surgery) calculated as oral morphine equivalents.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Postoperative Complications</measure>
    <time_frame>up to 120 hours</time_frame>
    <description>Includes urinary tract infections, thromboembolic events, pneumonia, postpartum blood transfusions, falls, myocardial infarctions.&#xD;
These events will be reported as frequencies of occurrence. (These will be reported as dichotomous &quot;Yes/No&quot; outcomes for each side effect)</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Opioid Pills Prescribed at Discharge</measure>
    <time_frame>up to 72 hours</time_frame>
    <description>The number of opioid pills prescribed at discharge</description>
  </other_outcome>
  <other_outcome>
    <measure>Neonatal Outcomes: Gestational Age at Delivery</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>Gestational age at delivery will be recorded as weeks and days of gestation</description>
  </other_outcome>
  <other_outcome>
    <measure>Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge</measure>
    <time_frame>up to 72 hours</time_frame>
    <description>Dose opioids (measured in total morphine milligram equivalents (mg) of all pills) prescribed at discharge</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Transdermal Lidocaine Patch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transdermal Hydrocolloid Placebo Patch</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Transdermal Lidocaine Patch</intervention_name>
    <description>Transdermal Lidocaine Patch</description>
    <arm_group_label>Transdermal Lidocaine Patch</arm_group_label>
    <other_name>Actavis US</other_name>
    <other_name>NDC 0591-3525-30</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Transdermal Hydrocolloid Placebo Patch</intervention_name>
    <description>hydrocolloid placebo patches</description>
    <arm_group_label>Transdermal Hydrocolloid Placebo Patch</arm_group_label>
    <other_name>DuoDerm</other_name>
    <other_name>ConvaTec</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Maternal age greater than or equal to 18&#xD;
&#xD;
          -  Prepregnancy body mass index greater than or equal to 30 kg/m2 or ≥35 kg/m2 at&#xD;
             delivery if no prepregnancy/ early pregnancy weight available&#xD;
&#xD;
          -  Singleton or multifetal pregnancy&#xD;
&#xD;
          -  Able to receive neuraxial analgesia&#xD;
&#xD;
          -  Planned/ scheduled Cesarean delivery OR non-urgent Cesarean delivery with adequate&#xD;
             time to consider and consent to the study&#xD;
&#xD;
          -  Gestational age greater or equal to 32 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to lidocaine or colloid patch (defined as a history of a&#xD;
             reaction or allergy to lidocaine (injectable, intravenous, or transdermal) or&#xD;
             hydrocolloid patch reported by patient or documented in the medical record) or patient&#xD;
             report&#xD;
&#xD;
          -  Contraindication to regional analgesia&#xD;
&#xD;
          -  Positive urine drug screen at admission to the hospital, if ordered for clinical&#xD;
             purposes.&#xD;
&#xD;
          -  Current opioid use or opioid use disorder per patient report or documented in the&#xD;
             medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery)&#xD;
&#xD;
          -  Chronic opioid use or opioid use disorder, either patient reported or documented in&#xD;
             the medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery), defined&#xD;
             as opioid use on most days for &gt;3 months&#xD;
&#xD;
          -  Planned Cesarean hysterectomy (excluded due to anticipated blood loss and alternative&#xD;
             pain control measures, possible prolonged intubation)&#xD;
&#xD;
          -  Planned vertical midline incision&#xD;
&#xD;
          -  Presence of renal dysfunction precluding the use of NSAIDs&#xD;
&#xD;
          -  Ischemic heart disease, congestive heart failure, or cardiomyopathy of pregnancy&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Planned discharge from the hospital less than 24 hours postpartum&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen Antony, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UW-Madison Obstetrics and Gynecology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UnityPoint Health-Meriter Hospital</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <results_first_submitted>July 9, 2020</results_first_submitted>
  <results_first_submitted_qc>August 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 7, 2020</results_first_posted>
  <last_update_submitted>October 28, 2022</last_update_submitted>
  <last_update_submitted_qc>October 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lidocaine</keyword>
  <keyword>patch</keyword>
  <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>Lidocaine</mesh_term>
  </intervention_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>May 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03810235/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 13, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03810235/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>3 participants delivered prior to randomization, leaving 63 participants to start the trial</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Transdermal Lidocaine Patch</title>
          <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Lidocaine Patch: Transdermal Lidocaine Patch</description>
        </group>
        <group group_id="P2">
          <title>Transdermal Hydrocolloid Placebo Patch</title>
          <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participant Data Analyzed</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>baseline characteristics for participants who completed the study</population>
      <group_list>
        <group group_id="B1">
          <title>Transdermal Lidocaine Patch</title>
          <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Lidocaine Patch: Transdermal Lidocaine Patch</description>
        </group>
        <group group_id="B2">
          <title>Transdermal Hydrocolloid Placebo Patch</title>
          <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="31"/>
            <count group_id="B3" value="61"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="32.6" spread="4.9"/>
                    <measurement group_id="B2" value="31.1" spread="5.2"/>
                    <measurement group_id="B3" value="31.83" spread="5.15"/>
                  </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="30"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </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="30"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity ( NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non- Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Dose of Opioids Received in the First 24 Hours Following Cesarean</title>
        <description>The total dose of opioids received in the first 24 hours following Cesarean delivery measured as oral morphine equivalents. This total dose will be calculated for every subject in the study, and the average and standard deviation (or appropriate non-parametric values if the data is not normally distributed) will be compared between the subjects randomized to the intervention arm and the placebo arm of the study.</description>
        <time_frame>up to 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transdermal Lidocaine Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Lidocaine Patch: Transdermal Lidocaine Patch</description>
          </group>
          <group group_id="O2">
            <title>Transdermal Hydrocolloid Placebo Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Dose of Opioids Received in the First 24 Hours Following Cesarean</title>
          <description>The total dose of opioids received in the first 24 hours following Cesarean delivery measured as oral morphine equivalents. This total dose will be calculated for every subject in the study, and the average and standard deviation (or appropriate non-parametric values if the data is not normally distributed) will be compared between the subjects randomized to the intervention arm and the placebo arm of the study.</description>
          <units>MME, morphine milligram equivalents</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87" spread="35.8"/>
                    <measurement group_id="O2" value="83.9" spread="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Pain Score at 24 Hours Post-operatively</title>
        <description>The post-operative pain score at 24 hours post-operatively will be measured using the numeric rating scale (NRS), wherein subjects rate pain on a 0-10 scale (10 meaning the most pain and 0 meaning no pain). The median NRS score at 24 hours will be compared between the two groups.</description>
        <time_frame>up to 24 hours</time_frame>
        <population>Median Pain Scores Overall and by Prepregancy and Delivery Body Mass Index (BMI)</population>
        <group_list>
          <group group_id="O1">
            <title>Transdermal Lidocaine Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Lidocaine Patch: Transdermal Lidocaine Patch</description>
          </group>
          <group group_id="O2">
            <title>Transdermal Hydrocolloid Placebo Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Pain Score at 24 Hours Post-operatively</title>
          <description>The post-operative pain score at 24 hours post-operatively will be measured using the numeric rating scale (NRS), wherein subjects rate pain on a 0-10 scale (10 meaning the most pain and 0 meaning no pain). The median NRS score at 24 hours will be compared between the two groups.</description>
          <population>Median Pain Scores Overall and by Prepregancy and Delivery Body Mass Index (BMI)</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Median Pain Score (0-10)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="1.0" upper_limit="9.5"/>
                    <measurement group_id="O2" value="3.5" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre pregnancy BMI 30-39.9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="2.0" upper_limit="3.2"/>
                    <measurement group_id="O2" value="3.0" lower_limit="2.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prepregancy BMI &gt;40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="2.6" upper_limit="4.0"/>
                    <measurement group_id="O2" value="4.0" lower_limit="3.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Delivery BMI 30 -39.9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="2.4" upper_limit="4.0"/>
                    <measurement group_id="O2" value="3.0" lower_limit="2.0" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Delivery BMI &gt;40</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="2.2" upper_limit="3.8"/>
                    <measurement group_id="O2" value="4.0" lower_limit="3.0" upper_limit="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Opioid-related Side Effects</title>
        <description>Patient-reported opioid-related side effects include pruritis, constipation, nausea, and mental clouding.&#xD;
Definition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous &quot;Yes/No&quot; outcomes for each side effect)</description>
        <time_frame>up to 6 weeks postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transdermal Lidocaine Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Lidocaine Patch: Transdermal Lidocaine Patch</description>
          </group>
          <group group_id="O2">
            <title>Transdermal Hydrocolloid Placebo Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Opioid-related Side Effects</title>
          <description>Patient-reported opioid-related side effects include pruritis, constipation, nausea, and mental clouding.&#xD;
Definition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous &quot;Yes/No&quot; outcomes for each side effect)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Complications of Lidocaine Use</title>
        <description>Complications of lidocaine use include local burning, nausea, dizziness, drowsiness, serious skin reactions such as blistering, confusion, blurred vision, ringing in the ears, and allergies and hypersensitivities.&#xD;
Definition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous &quot;Yes/No&quot; outcomes for each side effect)</description>
        <time_frame>up to 6 weeks postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transdermal Lidocaine Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Lidocaine Patch: Transdermal Lidocaine Patch</description>
          </group>
          <group group_id="O2">
            <title>Transdermal Hydrocolloid Placebo Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Complications of Lidocaine Use</title>
          <description>Complications of lidocaine use include local burning, nausea, dizziness, drowsiness, serious skin reactions such as blistering, confusion, blurred vision, ringing in the ears, and allergies and hypersensitivities.&#xD;
Definition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous &quot;Yes/No&quot; outcomes for each side effect)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Length of Hospital Stay</title>
        <description>Measured in hours from admission to time of discharge This will be measured in hours from the documented time of admission until discharge</description>
        <time_frame>up to 120 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transdermal Lidocaine Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Lidocaine Patch: Transdermal Lidocaine Patch</description>
          </group>
          <group group_id="O2">
            <title>Transdermal Hydrocolloid Placebo Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay</title>
          <description>Measured in hours from admission to time of discharge This will be measured in hours from the documented time of admission until discharge</description>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.5" lower_limit="70.4" upper_limit="96.4"/>
                    <measurement group_id="O2" value="76" lower_limit="71.3" upper_limit="91.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Time to First Rescue Opioid Analgesic Medication</title>
        <description>Measured in minutes from arrival in the post-anesthesia care unit (PACU) until the first as needed opioid dose is administered. This will be recorded in minutes from the time of the surgery completion (surgery end time) until the first opioid analgesic medication is administered. Data in table is noted in hours.</description>
        <time_frame>up to 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transdermal Lidocaine Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Lidocaine Patch: Transdermal Lidocaine Patch</description>
          </group>
          <group group_id="O2">
            <title>Transdermal Hydrocolloid Placebo Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Rescue Opioid Analgesic Medication</title>
          <description>Measured in minutes from arrival in the post-anesthesia care unit (PACU) until the first as needed opioid dose is administered. This will be recorded in minutes from the time of the surgery completion (surgery end time) until the first opioid analgesic medication is administered. Data in table is noted in hours.</description>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="0.2" upper_limit="4.5"/>
                    <measurement group_id="O2" value="1.7" lower_limit="0.2" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Total Dose of Opioids Used in the First 48 Hours Post-operatively</title>
        <description>All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received in 48 hours following surgery calculated as oral morphine equivalents</description>
        <time_frame>up to 48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transdermal Lidocaine Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Lidocaine Patch: Transdermal Lidocaine Patch</description>
          </group>
          <group group_id="O2">
            <title>Transdermal Hydrocolloid Placebo Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches</description>
          </group>
        </group_list>
        <measure>
          <title>Total Dose of Opioids Used in the First 48 Hours Post-operatively</title>
          <description>All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received in 48 hours following surgery calculated as oral morphine equivalents</description>
          <units>MME, morphine milligram equivalents</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149.3" spread="58.5"/>
                    <measurement group_id="O2" value="139.0" spread="48.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Total Dose of Opioids During the Whole Hospitalization.</title>
        <description>All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received during the hospitalization (following surgery) calculated as oral morphine equivalents.</description>
        <time_frame>up to 120 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transdermal Lidocaine Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Lidocaine Patch: Transdermal Lidocaine Patch</description>
          </group>
          <group group_id="O2">
            <title>Transdermal Hydrocolloid Placebo Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches</description>
          </group>
        </group_list>
        <measure>
          <title>Total Dose of Opioids During the Whole Hospitalization.</title>
          <description>All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received during the hospitalization (following surgery) calculated as oral morphine equivalents.</description>
          <units>MME, morphine milligram equivalents</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="200" lower_limit="0" upper_limit="448"/>
                    <measurement group_id="O2" value="192" lower_limit="42" upper_limit="388"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Postoperative Complications</title>
        <description>Includes urinary tract infections, thromboembolic events, pneumonia, postpartum blood transfusions, falls, myocardial infarctions.&#xD;
These events will be reported as frequencies of occurrence. (These will be reported as dichotomous &quot;Yes/No&quot; outcomes for each side effect)</description>
        <time_frame>up to 120 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transdermal Lidocaine Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Lidocaine Patch: Transdermal Lidocaine Patch</description>
          </group>
          <group group_id="O2">
            <title>Transdermal Hydrocolloid Placebo Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Postoperative Complications</title>
          <description>Includes urinary tract infections, thromboembolic events, pneumonia, postpartum blood transfusions, falls, myocardial infarctions.&#xD;
These events will be reported as frequencies of occurrence. (These will be reported as dichotomous &quot;Yes/No&quot; outcomes for each side effect)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Opioid Pills Prescribed at Discharge</title>
        <description>The number of opioid pills prescribed at discharge</description>
        <time_frame>up to 72 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transdermal Lidocaine Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Lidocaine Patch: Transdermal Lidocaine Patch</description>
          </group>
          <group group_id="O2">
            <title>Transdermal Hydrocolloid Placebo Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Opioid Pills Prescribed at Discharge</title>
          <description>The number of opioid pills prescribed at discharge</description>
          <units>Number of pills</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.3" spread="9.0"/>
                    <measurement group_id="O2" value="16.0" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Neonatal Outcomes: Gestational Age at Delivery</title>
        <description>Gestational age at delivery will be recorded as weeks and days of gestation</description>
        <time_frame>up to 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transdermal Lidocaine Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Lidocaine Patch: Transdermal Lidocaine Patch</description>
          </group>
          <group group_id="O2">
            <title>Transdermal Hydrocolloid Placebo Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.</description>
          </group>
        </group_list>
        <measure>
          <title>Neonatal Outcomes: Gestational Age at Delivery</title>
          <description>Gestational age at delivery will be recorded as weeks and days of gestation</description>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.7" spread="1.7"/>
                    <measurement group_id="O2" value="38.85" spread="1.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge</title>
        <description>Dose opioids (measured in total morphine milligram equivalents (mg) of all pills) prescribed at discharge</description>
        <time_frame>up to 72 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transdermal Lidocaine Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Lidocaine Patch: Transdermal Lidocaine Patch</description>
          </group>
          <group group_id="O2">
            <title>Transdermal Hydrocolloid Placebo Patch</title>
            <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge</title>
          <description>Dose opioids (measured in total morphine milligram equivalents (mg) of all pills) prescribed at discharge</description>
          <units>MME (mg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168.35" spread="120.4"/>
                    <measurement group_id="O2" value="154.10" spread="93.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks post partum</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Transdermal Lidocaine Patch</title>
          <description>Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Lidocaine Patch: Transdermal Lidocaine Patch</description>
        </group>
        <group group_id="E2">
          <title>Transdermal Hydrocolloid Placebo Patch</title>
          <description>Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.&#xD;
Transdermal Hydrocolloid Placebo Patch: hydrocolloid placebo patches</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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Adverse Event ( not serious)</sub_title>
                <description>Seen in ER after initial hospital discharge for abdominal pain: resolved spontaneously.&#xD;
Outcome: Recovered without sequelae Severity: Mild SAE Category: &quot;Other&quot; AE Treatment: None Action taken: None Attribution: Relatedness: Unrelated</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Adverse Event (not serious)</sub_title>
                <description>Delayed postpartum hemorrhage 6 weeks postpartum requiring D&amp;C Outcome: Recovered without sequelae Severity: Moderate SAE Category: Other AE Treatment: Non-mediation treatment Action taken with study: None Attribution/ relatedness: Unrelated</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="31"/>
              </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>Kathleen M. Antony, M.D, M.S.C.I</name_or_title>
      <organization>School of Medicine and Public Health University of Wisconsin-Madison</organization>
      <phone>608-417-6099</phone>
      <email>kantony@wisc.edu</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/NCT03810235
org study id: Meriter IRB 2018-015
secondary id: A532860
secondary id: SMPH/OBSTET & GYNECOL/OBSTET
secondary id: 2019-0139
nct id: NCT03810235
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study will be a single-center, single blind, randomized controlled trial. The study will
      be conducted at UnityPoint-Health Meriter Hospital under investigators from the University of
      Wisconsin-Madison. Obstetric patients with prepregnancy obesity undergoing a Cesarean
      delivery at UnityPoint-Health Meriter will be eligible.
The purpose of this study is to determine whether transdermal lidocaine administered at the
      time of Cesarean delivery and for 12 hours postoperatively will reduce the total dose of
      opioids received. Our hypothesis is that a lidocaine patch will reduce the total dose of
      opioids received in the immediate 24 hours post-delivery. Secondary outcomes will include
      patient self-reported pain scores, patient-reported incidence of side effects, such as
      pruritis, development of objective complications, such as serious skin reactions (examples
      are acute generalized exanthematous pustolosis, Stevens-Johnson syndrome, and toxic epidermal
      necrolysis), hypersensitivity, nausea, and nervousness. Other outcomes collected will include
      length of stay, time to first rescue analgesic medication, total dose of opioids in 48 hours,
      use of supplemental oxygen during hospitalization, total dose of opioids during
      hospitalization, breastfeeding rates, both exclusive and in combination with formula use,
      amount of opioid prescribed at discharge and whether refills were requested or administered,
      rates of chronic pain at six weeks postpartum, and six week Edinburgh Depression Screen
      scores. Neonatal outcomes such as five-minute Apgar scores and development of adverse
      outcomes will also be collected.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: single-center, single blind, randomized controlled trial
primary purpose: Treatment
masking: Single (Participant)
measure: Total Dose of Opioids Received in the First 24 Hours Following Cesarean
time frame: up to 24 hours
description: The total dose of opioids received in the first 24 hours following Cesarean delivery measured as oral morphine equivalents. This total dose will be calculated for every subject in the study, and the average and standard deviation (or appropriate non-parametric values if the data is not normally distributed) will be compared between the subjects randomized to the intervention arm and the placebo arm of the study.
measure: Post-operative Pain Score at 24 Hours Post-operatively
time frame: up to 24 hours
description: The post-operative pain score at 24 hours post-operatively will be measured using the numeric rating scale (NRS), wherein subjects rate pain on a 0-10 scale (10 meaning the most pain and 0 meaning no pain). The median NRS score at 24 hours will be compared between the two groups.
measure: Number of Participants With Opioid-related Side Effects
time frame: up to 6 weeks postpartum
description: Patient-reported opioid-related side effects include pruritis, constipation, nausea, and mental clouding.
Definition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect)
measure: Number of Participants With Complications of Lidocaine Use
time frame: up to 6 weeks postpartum
description: Complications of lidocaine use include local burning, nausea, dizziness, drowsiness, serious skin reactions such as blistering, confusion, blurred vision, ringing in the ears, and allergies and hypersensitivities.
Definition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect)
measure: Length of Hospital Stay
time frame: up to 120 hours
description: Measured in hours from admission to time of discharge This will be measured in hours from the documented time of admission until discharge
measure: Time to First Rescue Opioid Analgesic Medication
time frame: up to 24 hours
description: Measured in minutes from arrival in the post-anesthesia care unit (PACU) until the first as needed opioid dose is administered. This will be recorded in minutes from the time of the surgery completion (surgery end time) until the first opioid analgesic medication is administered. Data in table is noted in hours.
measure: Total Dose of Opioids Used in the First 48 Hours Post-operatively
time frame: up to 48 hours
description: All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received in 48 hours following surgery calculated as oral morphine equivalents
measure: Total Dose of Opioids During the Whole Hospitalization.
time frame: up to 120 hours
description: All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received during the hospitalization (following surgery) calculated as oral morphine equivalents.
measure: Number of Participants With Postoperative Complications
time frame: up to 120 hours
description: Includes urinary tract infections, thromboembolic events, pneumonia, postpartum blood transfusions, falls, myocardial infarctions.
These events will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect)
measure: Number of Opioid Pills Prescribed at Discharge
time frame: up to 72 hours
description: The number of opioid pills prescribed at discharge
measure: Neonatal Outcomes: Gestational Age at Delivery
time frame: up to 24 hours
description: Gestational age at delivery will be recorded as weeks and days of gestation
measure: Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge
time frame: up to 72 hours
description: Dose opioids (measured in total morphine milligram equivalents (mg) of all pills) prescribed at discharge
arm group label: Transdermal Lidocaine Patch
arm group type: Active Comparator
description: Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.
arm group label: Transdermal Hydrocolloid Placebo Patch
arm group type: Placebo Comparator
description: Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.
intervention type: Drug
intervention name: Transdermal Lidocaine Patch
description: Transdermal Lidocaine Patch
arm group label: Transdermal Lidocaine Patch
other name: Actavis US
other name: NDC 0591-3525-30
intervention type: Drug
intervention name: Transdermal Hydrocolloid Placebo Patch
description: hydrocolloid placebo patches
arm group label: Transdermal Hydrocolloid Placebo Patch
other name: DuoDerm
other name: ConvaTec
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathleen Antony, MD
role: Principal Investigator
affiliation: UW-Madison Obstetrics and Gynecology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Lidocaine
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 