<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/NCT03830307</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19010299</org_study_id>
    <nct_id>NCT03830307</nct_id>
  </id_info>
  <brief_title>NSS-Bridge Device for Post-Cesarean Delivery Pain</brief_title>
  <official_title>An Open-Label Application of the NSS-Bridge Device for Post-Cesarean Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grace Lim, MD, MS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current opioid epidemic has led to a renewed interest in exploring non-pharmacological&#xD;
      techniques to treat post-operative pain. An increasing number of patients are suffering from&#xD;
      the adverse effects of opioid use following surgery, including post-operative nausea and&#xD;
      vomiting, respiratory depression, immunosuppression, constipation, and most recently,&#xD;
      addiction. In the United States, over $600 billion is spent every year on opioid addiction,&#xD;
      including $79 billion related to opioid addiction following surgery. Despite many initiatives&#xD;
      to decrease the use of opiates in the preoperative setting, opioids continue to be regularly&#xD;
      prescribed before, during and after surgery. Although the risk of opioid addiction following&#xD;
      surgery is recognized, the percentage of patients becoming addicted to opioids following&#xD;
      surgery is not well understood. To date, there has been virtually no agreement regarding the&#xD;
      duration and dosage that qualify for opioid dependence following surgery, nor that a clear&#xD;
      estimation of the factors such as biological, psychosocial and socioeconomic that increase&#xD;
      the risk of using opioids for extended periods of time after surgery. Therefore, in order to&#xD;
      combat this growing health crisis at the ground level, it is incumbent upon the medical&#xD;
      community to explore alternative methods of pain control to treat the surgical population in&#xD;
      order to reduce the incidence of post-operative opioid addiction.&#xD;
&#xD;
      Percutaneous Nerve Field Stimulation (PNFS) is one of these recognized methods that ongoing&#xD;
      research has shown to be effective as a complementary method of pain management. While PNFS&#xD;
      is not a novel concept, clinical indications of auricular field stimulation have been limited&#xD;
      in the past due to requirement of bulky, stationary and non-disposable stimulators and&#xD;
      electrodes. These technological limitations made it difficult to establish the real clinical&#xD;
      potential of auricular stimulation for the perioperative management of pain in surgical&#xD;
      patients, despite the demonstration that auriculotherapy has been shown to relieve pain in&#xD;
      the postoperative setting.&#xD;
&#xD;
      The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field&#xD;
      stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by&#xD;
      the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes,&#xD;
      pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of&#xD;
      clinical symptoms related to opioid consumption and opioid withdrawal. These symptoms include&#xD;
      abdominal pain, anxiety and post-operative nausea and vomiting; conditions which are also&#xD;
      present following cesarean-section surgery. The use of the NSS-2 BRIDGE device has been&#xD;
      demonstrated to provide significant analgesia in patients with abdominal pain syndrome, and&#xD;
      clinical trials are ongoing to assess the benefit of this approach for post-operative pain&#xD;
      management. As compared to the present use of opioids for perioperative pain management, the&#xD;
      use of a complementary, non-pharmacologic approach offers the advantage of analgesia without&#xD;
      the associated side effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary purpose of this pilot study is to demonstrate feasibility/acceptability of the&#xD;
      BRIDGE device as applied after cesarean delivery. Once the feasibility/acceptability is&#xD;
      confirmed, the cesarean delivery model will be included in an NIH application related to the&#xD;
      use of devices to reduce opioid use. In this pilot period, no changes will be made in the&#xD;
      other routine analgesia/postpartum care. Following the same previously published approaches&#xD;
      from our group, potential subjects will be recruited in the Magee-Womens Hospital obstetrical&#xD;
      unit when they arrive for cesarean delivery. Patients will be asked if they are interested in&#xD;
      using the BRIDGE system as a way to control pain after the cesarean delivery. They will be&#xD;
      offered the option to review a video explaining the mechanism of action if the BRIDGE system.&#xD;
      They will also be provided with information about the acceptability of the BRIDGE device in&#xD;
      other clinical settings. Subjects will be informed of the purpose of this pilot evaluation&#xD;
      and signed written informed consent to participate in the study.&#xD;
&#xD;
      Once the subject has given and signed informed consent to participate in the study,&#xD;
      demographic information and medical history will be collected from each participant on the&#xD;
      day of the cesarean delivery. Data will be de-identified and kept in a locked cabinet and&#xD;
      secured servers. The NSS-2 BRIDGE device will be applied to one ear by trained research staff&#xD;
      in the immediate post-operative setting. The patient will be informed at the time of consent&#xD;
      and after the implantation of the device that they can have the device removed anytime after&#xD;
      its application.&#xD;
&#xD;
      Per current standard of care, pain will be assessed in the postpartum period. At 24, 48, 72,&#xD;
      96 and 120 hours post-operatively the investigators will collected pain scores at rest and&#xD;
      movement, pain unpleasantness, total opioid consumption (from the medical record), as well as&#xD;
      the devise tolerability.&#xD;
&#xD;
      The investigators will also collect common medical information including time to bowel&#xD;
      movement, postoperative nausea and vomiting (PONV), time to oral intake (liquid and regular&#xD;
      diet), time to hospital discharge, overall patient satisfaction, and patient satisfaction&#xD;
      related to pain management. When the patient is discharged from the hospital, they will be&#xD;
      asked to complete a patient satisfaction survey. For patients discharged with the device&#xD;
      attached, removal instructions will be given to patient to remove and dispose of the device&#xD;
      at 120 hours.&#xD;
&#xD;
      Standard opioid conversion table will be used to convert the oral and IV narcotic utilized by&#xD;
      the patients to IV morphine equivalent doses (MED) for analysis purposes.&#xD;
&#xD;
      Overall patient satisfaction and satisfaction of pain management during hospitalization will&#xD;
      be measured by a numerical rating scale with 0 being worst satisfaction and 10 being the best&#xD;
      satisfaction. The patient satisfaction test will be administered by a member of the research&#xD;
      team.&#xD;
&#xD;
      No statistical analysis will be performed. The primary end point for this pilot phase will be&#xD;
      the descriptive feasibility and acceptability of the use of this device un cesarean delivery&#xD;
      population. We will assess the experience of device tolerability along with pain intensity.&#xD;
      Pain intensity scores and opioid consumption will be compared to data obtained from&#xD;
      historical data of women undergoing cesarean delivery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2019</start_date>
  <completion_date type="Actual">April 4, 2019</completion_date>
  <primary_completion_date type="Actual">April 4, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid Consumption</measure>
    <time_frame>Day of surgery through post-operative day 5</time_frame>
    <description>Investigate the efficacy of the NSS-2 BRIDGE device in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery using the current post-operative standard of care.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Post-operative Complications</measure>
    <time_frame>Day of Surgery through 90 days post-operative</time_frame>
    <description>Investigate the incidence of post-operative complications for patients receiving the NSS-2-Bridge device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of NSS-2 Bridge Device: Opioid Consumption</measure>
    <time_frame>Day of Surgery through 90 days post-operative</time_frame>
    <description>Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Comfort Wearing NSS-2 Bridge Device</measure>
    <time_frame>24 hours post-operatively</time_frame>
    <description>Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Comfort Wearing NSS-2 Bridge Device</measure>
    <time_frame>48 hours post-operatively</time_frame>
    <description>Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Comfort Wearing NSS-2 Bridge Device</measure>
    <time_frame>72 hours post-operatively</time_frame>
    <description>Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Comfort Wearing NSS-2 Bridge Device</measure>
    <time_frame>96 hours post-operatively</time_frame>
    <description>Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Comfort Wearing NSS-2 Bridge Device</measure>
    <time_frame>120 hours post-operatively</time_frame>
    <description>Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score at Rest</measure>
    <time_frame>24 hours post-operatively</time_frame>
    <description>Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score at Rest</measure>
    <time_frame>48 hours post-operatively</time_frame>
    <description>Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score at Rest</measure>
    <time_frame>72 hours post-operatively</time_frame>
    <description>Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score at Rest</measure>
    <time_frame>96 hours post-operatively</time_frame>
    <description>Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score at Rest</measure>
    <time_frame>120 hours post-operatively</time_frame>
    <description>=Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score With Movement</measure>
    <time_frame>24 hours post-operatively</time_frame>
    <description>Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score With Movement</measure>
    <time_frame>48 hours post-operatively</time_frame>
    <description>Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score With Movement</measure>
    <time_frame>72 hours post-operatively</time_frame>
    <description>Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score With Movement</measure>
    <time_frame>96 hours post-operatively</time_frame>
    <description>Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score With Movement</measure>
    <time_frame>120 hours post-operatively</time_frame>
    <description>Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Acute Pain</condition>
  <condition>Cesarean Delivery</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NSS-2-Bridge</intervention_name>
    <description>NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  Cesarean delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of active depression, anxiety or catastrophizing&#xD;
&#xD;
          -  Active alcoholism or drug abuse&#xD;
&#xD;
          -  Severe chronic pain condition that requires daily preoperative opioid use&#xD;
&#xD;
          -  Current opioid maintenance therapy/use for any other reason&#xD;
&#xD;
          -  History of hemophilia&#xD;
&#xD;
          -  Patients with cardiac pacemakers&#xD;
&#xD;
          -  Patients with psoriasis vulgaris diagnosis or other skin conditions affecting the ear&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grace Lim, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Magee-Womens Hospital of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <results_first_submitted>January 13, 2020</results_first_submitted>
  <results_first_submitted_qc>March 26, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 27, 2020</results_first_posted>
  <last_update_submitted>March 26, 2020</last_update_submitted>
  <last_update_submitted_qc>March 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Grace Lim, MD, MS</investigator_full_name>
    <investigator_title>Director of Obstetric Anesthesia</investigator_title>
  </responsible_party>
  <keyword>Pain Therapy</keyword>
  <keyword>Auriculotherapy</keyword>
  <keyword>Cesarean Delivery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03830307/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment Period was from 3/11/2019-3/29/2019</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention Group</title>
          <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </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>Intervention Group</title>
          <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </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 and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Opioid Consumption</title>
        <description>Investigate the efficacy of the NSS-2 BRIDGE device in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery using the current post-operative standard of care.</description>
        <time_frame>Day of surgery through post-operative day 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Consumption</title>
          <description>Investigate the efficacy of the NSS-2 BRIDGE device in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery using the current post-operative standard of care.</description>
          <units>milligrams of oxycodone</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31" lower_limit="0" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Post-operative Complications</title>
        <description>Investigate the incidence of post-operative complications for patients receiving the NSS-2-Bridge device.</description>
        <time_frame>Day of Surgery through 90 days post-operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Post-operative Complications</title>
          <description>Investigate the incidence of post-operative complications for patients receiving the NSS-2-Bridge device.</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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy of NSS-2 Bridge Device: Opioid Consumption</title>
        <description>Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery.</description>
        <time_frame>Day of Surgery through 90 days post-operative</time_frame>
        <population>90 follow-up of opioid medication was not collected in intervention group</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy of NSS-2 Bridge Device: Opioid Consumption</title>
          <description>Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery.</description>
          <population>90 follow-up of opioid medication was not collected in intervention group</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Level of Comfort Wearing NSS-2 Bridge Device</title>
        <description>Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
        <time_frame>24 hours post-operatively</time_frame>
        <population>Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Level of Comfort Wearing NSS-2 Bridge Device</title>
          <description>Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
          <population>Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="0" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Level of Comfort Wearing NSS-2 Bridge Device</title>
        <description>Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
        <time_frame>48 hours post-operatively</time_frame>
        <population>Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Level of Comfort Wearing NSS-2 Bridge Device</title>
          <description>Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
          <population>Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Level of Comfort Wearing NSS-2 Bridge Device</title>
        <description>Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
        <time_frame>72 hours post-operatively</time_frame>
        <population>Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Level of Comfort Wearing NSS-2 Bridge Device</title>
          <description>Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
          <population>Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Level of Comfort Wearing NSS-2 Bridge Device</title>
        <description>Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
        <time_frame>96 hours post-operatively</time_frame>
        <population>Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Level of Comfort Wearing NSS-2 Bridge Device</title>
          <description>Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
          <population>Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Level of Comfort Wearing NSS-2 Bridge Device</title>
        <description>Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
        <time_frame>120 hours post-operatively</time_frame>
        <population>Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Level of Comfort Wearing NSS-2 Bridge Device</title>
          <description>Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
          <population>Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score at Rest</title>
        <description>Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
        <time_frame>24 hours post-operatively</time_frame>
        <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score at Rest</title>
          <description>Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
          <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score at Rest</title>
        <description>Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
        <time_frame>48 hours post-operatively</time_frame>
        <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score at Rest</title>
          <description>Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
          <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="2" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score at Rest</title>
        <description>Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
        <time_frame>72 hours post-operatively</time_frame>
        <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score at Rest</title>
          <description>Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
          <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="0" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score at Rest</title>
        <description>Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
        <time_frame>96 hours post-operatively</time_frame>
        <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score at Rest</title>
          <description>Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
          <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score at Rest</title>
        <description>=Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
        <time_frame>120 hours post-operatively</time_frame>
        <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score at Rest</title>
          <description>=Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
          <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score With Movement</title>
        <description>Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
        <time_frame>24 hours post-operatively</time_frame>
        <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score With Movement</title>
          <description>Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
          <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="0" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score With Movement</title>
        <description>Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
        <time_frame>48 hours post-operatively</time_frame>
        <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score With Movement</title>
          <description>Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
          <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="2" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score With Movement</title>
        <description>Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
        <time_frame>72 hours post-operatively</time_frame>
        <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score With Movement</title>
          <description>Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
          <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="2" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score With Movement</title>
        <description>Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
        <time_frame>96 hours post-operatively</time_frame>
        <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score With Movement</title>
          <description>Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
          <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="2" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score With Movement</title>
        <description>Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
        <time_frame>120 hours post-operatively</time_frame>
        <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score With Movement</title>
          <description>Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.</description>
          <population>Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="2" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>90 days</time_frame>
      <desc>The subjects' medical record charts were reviewed daily by research staff and any findings would be assessed by the principal investigator.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention Group</title>
          <description>The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.&#xD;
NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care</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="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </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="5"/>
              </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. Grace Lim</name_or_title>
      <organization>University of Pittsburgh</organization>
      <phone>412-641-4260</phone>
      <email>limkg2@upmc.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/NCT03830307
org study id: STUDY19010299
nct id: NCT03830307
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The current opioid epidemic has led to a renewed interest in exploring non-pharmacological
      techniques to treat post-operative pain. An increasing number of patients are suffering from
      the adverse effects of opioid use following surgery, including post-operative nausea and
      vomiting, respiratory depression, immunosuppression, constipation, and most recently,
      addiction. In the United States, over $600 billion is spent every year on opioid addiction,
      including $79 billion related to opioid addiction following surgery. Despite many initiatives
      to decrease the use of opiates in the preoperative setting, opioids continue to be regularly
      prescribed before, during and after surgery. Although the risk of opioid addiction following
      surgery is recognized, the percentage of patients becoming addicted to opioids following
      surgery is not well understood. To date, there has been virtually no agreement regarding the
      duration and dosage that qualify for opioid dependence following surgery, nor that a clear
      estimation of the factors such as biological, psychosocial and socioeconomic that increase
      the risk of using opioids for extended periods of time after surgery. Therefore, in order to
      combat this growing health crisis at the ground level, it is incumbent upon the medical
      community to explore alternative methods of pain control to treat the surgical population in
      order to reduce the incidence of post-operative opioid addiction.

      Percutaneous Nerve Field Stimulation (PNFS) is one of these recognized methods that ongoing
      research has shown to be effective as a complementary method of pain management. While PNFS
      is not a novel concept, clinical indications of auricular field stimulation have been limited
      in the past due to requirement of bulky, stationary and non-disposable stimulators and
      electrodes. These technological limitations made it difficult to establish the real clinical
      potential of auricular stimulation for the perioperative management of pain in surgical
      patients, despite the demonstration that auriculotherapy has been shown to relieve pain in
      the postoperative setting.

      The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field
      stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by
      the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes,
      pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of
      clinical symptoms related to opioid consumption and opioid withdrawal. These symptoms include
      abdominal pain, anxiety and post-operative nausea and vomiting; conditions which are also
      present following cesarean-section surgery. The use of the NSS-2 BRIDGE device has been
      demonstrated to provide significant analgesia in patients with abdominal pain syndrome, and
      clinical trials are ongoing to assess the benefit of this approach for post-operative pain
      management. As compared to the present use of opioids for perioperative pain management, the
      use of a complementary, non-pharmacologic approach offers the advantage of analgesia without
      the associated side effects.
The primary purpose of this pilot study is to demonstrate feasibility/acceptability of the
      BRIDGE device as applied after cesarean delivery. Once the feasibility/acceptability is
      confirmed, the cesarean delivery model will be included in an NIH application related to the
      use of devices to reduce opioid use. In this pilot period, no changes will be made in the
      other routine analgesia/postpartum care. Following the same previously published approaches
      from our group, potential subjects will be recruited in the Magee-Womens Hospital obstetrical
      unit when they arrive for cesarean delivery. Patients will be asked if they are interested in
      using the BRIDGE system as a way to control pain after the cesarean delivery. They will be
      offered the option to review a video explaining the mechanism of action if the BRIDGE system.
      They will also be provided with information about the acceptability of the BRIDGE device in
      other clinical settings. Subjects will be informed of the purpose of this pilot evaluation
      and signed written informed consent to participate in the study.

      Once the subject has given and signed informed consent to participate in the study,
      demographic information and medical history will be collected from each participant on the
      day of the cesarean delivery. Data will be de-identified and kept in a locked cabinet and
      secured servers. The NSS-2 BRIDGE device will be applied to one ear by trained research staff
      in the immediate post-operative setting. The patient will be informed at the time of consent
      and after the implantation of the device that they can have the device removed anytime after
      its application.

      Per current standard of care, pain will be assessed in the postpartum period. At 24, 48, 72,
      96 and 120 hours post-operatively the investigators will collected pain scores at rest and
      movement, pain unpleasantness, total opioid consumption (from the medical record), as well as
      the devise tolerability.

      The investigators will also collect common medical information including time to bowel
      movement, postoperative nausea and vomiting (PONV), time to oral intake (liquid and regular
      diet), time to hospital discharge, overall patient satisfaction, and patient satisfaction
      related to pain management. When the patient is discharged from the hospital, they will be
      asked to complete a patient satisfaction survey. For patients discharged with the device
      attached, removal instructions will be given to patient to remove and dispose of the device
      at 120 hours.

      Standard opioid conversion table will be used to convert the oral and IV narcotic utilized by
      the patients to IV morphine equivalent doses (MED) for analysis purposes.

      Overall patient satisfaction and satisfaction of pain management during hospitalization will
      be measured by a numerical rating scale with 0 being worst satisfaction and 10 being the best
      satisfaction. The patient satisfaction test will be administered by a member of the research
      team.

      No statistical analysis will be performed. The primary end point for this pilot phase will be
      the descriptive feasibility and acceptability of the use of this device un cesarean delivery
      population. We will assess the experience of device tolerability along with pain intensity.
      Pain intensity scores and opioid consumption will be compared to data obtained from
      historical data of women undergoing cesarean delivery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Opioid Consumption
time frame: Day of surgery through post-operative day 5
description: Investigate the efficacy of the NSS-2 BRIDGE device in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery using the current post-operative standard of care.
measure: Number of Participants With Post-operative Complications
time frame: Day of Surgery through 90 days post-operative
description: Investigate the incidence of post-operative complications for patients receiving the NSS-2-Bridge device.
measure: Efficacy of NSS-2 Bridge Device: Opioid Consumption
time frame: Day of Surgery through 90 days post-operative
description: Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery.
measure: Level of Comfort Wearing NSS-2 Bridge Device
time frame: 24 hours post-operatively
description: Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
measure: Level of Comfort Wearing NSS-2 Bridge Device
time frame: 48 hours post-operatively
description: Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
measure: Level of Comfort Wearing NSS-2 Bridge Device
time frame: 72 hours post-operatively
description: Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
measure: Level of Comfort Wearing NSS-2 Bridge Device
time frame: 96 hours post-operatively
description: Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
measure: Level of Comfort Wearing NSS-2 Bridge Device
time frame: 120 hours post-operatively
description: Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
measure: Pain Score at Rest
time frame: 24 hours post-operatively
description: Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
measure: Pain Score at Rest
time frame: 48 hours post-operatively
description: Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
measure: Pain Score at Rest
time frame: 72 hours post-operatively
description: Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
measure: Pain Score at Rest
time frame: 96 hours post-operatively
description: Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
measure: Pain Score at Rest
time frame: 120 hours post-operatively
description: =Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
measure: Pain Score With Movement
time frame: 24 hours post-operatively
description: Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
measure: Pain Score With Movement
time frame: 48 hours post-operatively
description: Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
measure: Pain Score With Movement
time frame: 72 hours post-operatively
description: Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
measure: Pain Score With Movement
time frame: 96 hours post-operatively
description: Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
measure: Pain Score With Movement
time frame: 120 hours post-operatively
description: Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
arm group label: Intervention Group
arm group type: Experimental
description: The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.
intervention type: Device
intervention name: NSS-2-Bridge
description: NSS-2-Bridge auricular therapy will be given in addition to standard of care
arm group label: Intervention Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Grace Lim, MD, MS
role: Principal Investigator
affiliation: University of Pittsburgh Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Grace Lim, MD, MS
investigator title: Director of Obstetric Anesthesia
mesh term: Acute Pain
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 