<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/NCT03834142</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19020023</org_study_id>
    <nct_id>NCT03834142</nct_id>
  </id_info>
  <brief_title>NSS-2-BRIDGE Study for Total Knee and Hip Arthroplasties, Bariatric, and Kidney Transplant Surgeries</brief_title>
  <official_title>Pilot Study to Investigate the Feasibility and Tolerability of the Use of NSS-2-BRIDGE Device for Post-Operative Pain in Total Knee and Hip Arthroplasties, Bariatric, and Kidney Transplant Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jacques E. Chelly</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 change 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;
      pain, anxiety and post-operative nausea and vomiting; conditions which are also present&#xD;
      following major orthopedic surgery such as knee and hip arthroplasties. The use of the NSS-2&#xD;
      BRIDGE device has been demonstrated to provide significant analgesia in patients with&#xD;
      abdominal pain syndrome, and clinical trials are ongoing to assess the benefit of this&#xD;
      approach for post-operative pain management. As compared to the present use of opioids for&#xD;
      perioperative pain management, the use of a complementary, non-pharmacologic approach offers&#xD;
      the advantage of analgesia without the associated side effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open-label, pilot study will investigate forty individuals, ten of which will be scheduled&#xD;
      for total hip arthroplasty, ten will be scheduled for total knee arthroplasty, ten scheduled&#xD;
      for kidney transplant and ten for bariatric surgery, will be approached and consented for&#xD;
      this trial. Their data in regards to their post-operative pain, nausea, and analgesia use&#xD;
      will be compared to 10 historic subjects who had the same surgeries in January (TKA/THA) or&#xD;
      September (kidney transplant/bariatric) of 2019. The subjects who receive the NSS-2-BRIDGE&#xD;
      will also be monitored for comfort with the device for the tolerability and feasibility of&#xD;
      utilizing this device in the future to treat post-operative pain.&#xD;
&#xD;
      Once a patient has given and signed informed consent to participate in the study, demographic&#xD;
      information and medical history will be collected from each participant on the day of the&#xD;
      joint replacement/kidney transplant/bariatric surgery. Data will be de-identified and kept in&#xD;
      a locked cabinet in a locked office. The PI and the research coordinator have been trained in&#xD;
      placing the NSS-2-BRIDGE and will apply the device in the immediate post-operative setting&#xD;
      (post-anesthesia care unit, PACU). The device will be attached behind the ear with&#xD;
      double-sided tape. It contains three electrodes which will be applied to the ear and a ground&#xD;
      which will be placed on the patient's lobe. Each electrode and the ground will be secured&#xD;
      with adhesive bandages. The patient will be informed at the time of consent and after the&#xD;
      implantation of the device that they can have the device removed any time after its&#xD;
      application. Once the device is placed patients will be asked to perform a &quot;pinch test&quot;&#xD;
      throughout the duration of their time wearing the device. To perform the &quot;pinch test&quot; they&#xD;
      must pinch down on the electrodes and ground to ensure they are still placed in their&#xD;
      designated locations and have not come loose.&#xD;
&#xD;
      As per standard of care, at 24, 48, 72, 96 and 120 hours post-operatively pain scores will be&#xD;
      collected at rest and movement, total opioid consumption, as well as the devise tolerability.&#xD;
      Additionally as per other pain pilot IRB approved projects, we shall also collect common&#xD;
      medical information including time to bowel movement, PONV, time to oral intake (liquid and&#xD;
      regular diet), time to hospital discharge, intensive care unit (ICU) admission, readmission&#xD;
      to the hospital, readmission due to pain related issues, quality of recovery after joint&#xD;
      replacement, overall patient satisfaction, and patient satisfaction related to pain&#xD;
      management.&#xD;
&#xD;
      When the patient is discharged from the hospital, they will be asked to complete a patient&#xD;
      satisfaction survey. If the patient should be discharged prior to 120 hours post-operatively,&#xD;
      they will be asked to wear the device home. They will also be ask to remove the device at 120&#xD;
      hours (five days) after device placement and dispose of it in their home. We will provide&#xD;
      removal instructions. Data post- hospital discharge regarding pain scores, opioid&#xD;
      consumption, and device tolerability will be collected after discharge by calling the patient&#xD;
      every day for 120 hr. following the placement of the device.&#xD;
&#xD;
      At UPMC Shadyside, we expect the patients undergoing primary unilateral either total hip or&#xD;
      total knee surgery to be discharged on the day of surgery, or the next day but no later than&#xD;
      48 hrs following surgery. Therefore, for the patients in whom a Bridge device will be placed&#xD;
      following surgery, it will be possible to document, if during the 120 hrs following the&#xD;
      placement of the device, the patient returned to the hospital because of pain. This will be&#xD;
      documented in the patient chart and therefore will be available for review.&#xD;
&#xD;
      Given that most post-bariatric patients are discharged at 72 hours or before, pain scores,&#xD;
      opioid needs, and device tolerability at 96 and 120 hours will be collected from the patient&#xD;
      by calling them after discharge. Participants will be called once daily up until day 5 and&#xD;
      asked to report information. Phone calls to patients after discharge are consistent with&#xD;
      routine clinical care. If the kidney transplant patient is discharged prior to 120 hours (5&#xD;
      days), they will also be called daily to record pain scores, opioid needs, and device&#xD;
      tolerability for the time they are discharged up to 5 days post-device placement.&#xD;
&#xD;
      As stated in the protocol, each patient will be discharged according to the standard protocol&#xD;
      defined by the surgical team. Data collected for both historical and study subjects will be&#xD;
      the base of the standard clinical data collected for any patient undergoing surgery at UPMC&#xD;
      SDY, UPMC Montefiore and UPMC MWH. After the patient is discharged from the hospital data&#xD;
      related to pain, nausea and vomiting and opioid consumption will be obtained by a daily phone&#xD;
      call.&#xD;
&#xD;
      The historical controls will include a medical chart review of patients from the Acute&#xD;
      Perioperative Pain Service at UPMC Shadyside Hospital. Data collection includes total&#xD;
      narcotic/non-opioid analgesic requirement, pain scores and nausea and vomiting after the&#xD;
      surgery. Other information collected from the medical record will include age, race and&#xD;
      medical history. Additionally, we will also collect common medical information including time&#xD;
      to bowel movement, time to oral intake (liquid and regular diet), time to hospital discharge,&#xD;
      intensive care unit (ICU) admission, readmission to the hospital, readmission due to pain&#xD;
      related issues. No Personal Health Identifiers will be collected from the historical&#xD;
      controls.&#xD;
&#xD;
      The subjects in whom the Bridge device will be placed will receive the same standard ERAS&#xD;
      protocol as the patients who will be used as historical control.&#xD;
&#xD;
      No power analysis will be performed. However, the tolerability of the placement of the bridge&#xD;
      device (focus of this study) will be assessed using the pain scores.&#xD;
&#xD;
      We will record pain scores before and after the placement of the Device (prior to leaving the&#xD;
      recovering room, and at 24, 48, 72, 96 and 120 or until discharge from the hospital) and&#xD;
      compare it to the historical data of pain scores recorded prior to discharge from the&#xD;
      hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 8, 2019</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>10 subjects will be recruited in each surgical population (hip/knee, kidney, bariatric) to equal 30 total active participants. This will be compared to 10 controls in each surgical population, for a total of 60 participants in the entire pilot.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of NSS-2 Bridge Device in Changing Perioperative Opioid Consumption</measure>
    <time_frame>This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.</time_frame>
    <description>Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing either a total hip or total knee arthroplasty procedure, bariatric or kidney donor surgeries. Since we are comparing to historical controls, we can only analyze data from when the controls were in the hospital. This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Scores</measure>
    <time_frame>Day of Surgery, 24 hours post-operative, 48 hours post-operative</time_frame>
    <description>Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative NRS Pain scores in opioid-naïve patients undergoing either a total hip or total knee arthroplasty, bariatric or kidney donor surgeries. Since we are comparing to historical controls, we can only analyze data from when the controls were in the hospital.&#xD;
Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. higher scores represent a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Post-operative Complications</measure>
    <time_frame>Day of Surgery through post-operative day 5</time_frame>
    <description>Investigate the number of participants that experienced post-operative complications .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Comfort Wearing NSS-2 Bridge Device</measure>
    <time_frame>Post-operative day 5</time_frame>
    <description>This was determined by asking the subject &quot;How satisfied were you with the NSS-Bridge Device during the time in which it was worn, with 0 being the worst and 10 being the most satisfied?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Hospital Discharge</measure>
    <time_frame>Day of Surgery to post-op day 5</time_frame>
    <description>Length of time from end of surgery to discharge from hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Discharge From Recovery Room</measure>
    <time_frame>Day of Surgery through post-operative day 5</time_frame>
    <description>Length of time from end of surgery to discharge from the recovery room</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Oral Intake</measure>
    <time_frame>Day of surgery to post-op day 5</time_frame>
    <description>Length of time from end of surgery to first oral intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Ambulation</measure>
    <time_frame>Day of surgery to post-op day 5</time_frame>
    <description>Length of time from end of surgery to first ambulation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Acute Pain</condition>
  <condition>Arthropathy of Knee</condition>
  <condition>Arthropathy of Hip</condition>
  <condition>Pain, Postoperative</condition>
  <condition>Kidney Transplant Donor</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NSS-2-Bridge auricular therapy will be given in addition to standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention, subject receives standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NSS-2 Bridge</intervention_name>
    <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_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  Elective Total Knee OR Total Hip Arthroplasties OR Kidney transplant surgery OR&#xD;
             Bariatric surgery&#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 dependence&#xD;
&#xD;
          -  History of hemophilia&#xD;
&#xD;
          -  Patients with cardiac pacemakers or other implanted devices (e.g. vagal nerve&#xD;
             simulators)&#xD;
&#xD;
          -  Patients with psoriasis vulgaris diagnosis&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Jacques E Chelly, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UPMC Magee-Womens Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Presbyterian</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Shadyside Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <results_first_submitted>April 4, 2022</results_first_submitted>
  <results_first_submitted_qc>July 8, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 3, 2022</results_first_posted>
  <last_update_submitted>July 8, 2022</last_update_submitted>
  <last_update_submitted_qc>July 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Jacques E. Chelly</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Auriculotherapy</keyword>
  <keyword>Pain Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <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>September 26, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03834142/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention-Kidney</title>
          <description>NSS-2-Bridge auricular therapy will be given in addition to standard of care.&#xD;
NSS-2 Bridge: 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>
        </group>
        <group group_id="P2">
          <title>Control-Kidney</title>
          <description>Subject receives 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="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Kidney Transplant Donor</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>NSS-2-Bridge auricular therapy will be given in addition to standard of care.&#xD;
NSS-2 Bridge: 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>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>No intervention, subject receives standard of care</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="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </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="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </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="43.5" spread="12.7"/>
                    <measurement group_id="B2" value="42" spread="11.7"/>
                    <measurement group_id="B3" value="42.4" spread="11.6"/>
                  </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="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Efficacy of NSS-2 Bridge Device in Changing Perioperative Opioid Consumption</title>
        <description>Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing either a total hip or total knee arthroplasty procedure, bariatric or kidney donor surgeries. Since we are comparing to historical controls, we can only analyze data from when the controls were in the hospital. This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.</description>
        <time_frame>This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.</time_frame>
        <population>Kidney Transplant Donor</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>NSS-2-Bridge auricular therapy will be given in addition to standard of care.&#xD;
NSS-2 Bridge: 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>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>No intervention, subject receives standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy of NSS-2 Bridge Device in Changing Perioperative Opioid Consumption</title>
          <description>Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing either a total hip or total knee arthroplasty procedure, bariatric or kidney donor surgeries. Since we are comparing to historical controls, we can only analyze data from when the controls were in the hospital. This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.</description>
          <population>Kidney Transplant Donor</population>
          <units>mg morphine equivalent (MME)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" spread="9.6"/>
                    <measurement group_id="O2" value="33.5" spread="37.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Scores</title>
        <description>Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative NRS Pain scores in opioid-naïve patients undergoing either a total hip or total knee arthroplasty, bariatric or kidney donor surgeries. Since we are comparing to historical controls, we can only analyze data from when the controls were in the hospital.&#xD;
Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. higher scores represent a worse outcome.</description>
        <time_frame>Day of Surgery, 24 hours post-operative, 48 hours post-operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention-Kidney</title>
            <description>NSS-2-Bridge auricular therapy will be given in addition to standard of care.&#xD;
NSS-2 Bridge: 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>
          </group>
          <group group_id="O2">
            <title>Control-Kidney</title>
            <description>Subject receives standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Scores</title>
          <description>Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative NRS Pain scores in opioid-naïve patients undergoing either a total hip or total knee arthroplasty, bariatric or kidney donor surgeries. Since we are comparing to historical controls, we can only analyze data from when the controls were in the hospital.&#xD;
Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. higher scores represent a worse outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-op 24 hour Pain Scores</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="2.0"/>
                    <measurement group_id="O2" value="6" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-op 48 hour Pain Scores</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="1.6"/>
                    <measurement group_id="O2" value="6.0" spread="2.8"/>
                  </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 number of participants that experienced post-operative complications .</description>
        <time_frame>Day of Surgery through post-operative day 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention-Kidney</title>
            <description>NSS-2-Bridge auricular therapy will be given in addition to standard of care.&#xD;
NSS-2 Bridge: 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>
          </group>
          <group group_id="O2">
            <title>Control-Kidney</title>
            <description>Subject receives standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Post-operative Complications</title>
          <description>Investigate the number of participants that experienced post-operative complications .</description>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </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>Secondary</type>
        <title>Level of Comfort Wearing NSS-2 Bridge Device</title>
        <description>This was determined by asking the subject &quot;How satisfied were you with the NSS-Bridge Device during the time in which it was worn, with 0 being the worst and 10 being the most satisfied?&quot;</description>
        <time_frame>Post-operative day 5</time_frame>
        <population>We were not able to reach 1 patient for the day 5 follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention - Kidney</title>
            <description>NSS-2-Bridge auricular therapy will be given in addition to standard of care.&#xD;
NSS-2 Bridge: 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>
          </group>
        </group_list>
        <measure>
          <title>Level of Comfort Wearing NSS-2 Bridge Device</title>
          <description>This was determined by asking the subject &quot;How satisfied were you with the NSS-Bridge Device during the time in which it was worn, with 0 being the worst and 10 being the most satisfied?&quot;</description>
          <population>We were not able to reach 1 patient for the day 5 follow-up.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Hospital Discharge</title>
        <description>Length of time from end of surgery to discharge from hospital</description>
        <time_frame>Day of Surgery to post-op day 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention-Kidney</title>
            <description>NSS-2-Bridge auricular therapy will be given in addition to standard of care.&#xD;
NSS-2 Bridge: 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>
          </group>
          <group group_id="O2">
            <title>Control-Kidney</title>
            <description>Subject receives standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Hospital Discharge</title>
          <description>Length of time from end of surgery to discharge from hospital</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="2.9"/>
                    <measurement group_id="O2" value="2.2" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Discharge From Recovery Room</title>
        <description>Length of time from end of surgery to discharge from the recovery room</description>
        <time_frame>Day of Surgery through post-operative day 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention-Kidney</title>
            <description>NSS-2-Bridge auricular therapy will be given in addition to standard of care.&#xD;
NSS-2 Bridge: 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>
          </group>
          <group group_id="O2">
            <title>Control-Kidney</title>
            <description>Subject receives standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Discharge From Recovery Room</title>
          <description>Length of time from end of surgery to discharge from the recovery room</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134.9" spread="37.7"/>
                    <measurement group_id="O2" value="197.3" spread="152.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Oral Intake</title>
        <description>Length of time from end of surgery to first oral intake</description>
        <time_frame>Day of surgery to post-op day 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention-Kidney</title>
            <description>NSS-2-Bridge auricular therapy will be given in addition to standard of care.&#xD;
NSS-2 Bridge: 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>
          </group>
          <group group_id="O2">
            <title>Control-Kidney</title>
            <description>Subject receives standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Oral Intake</title>
          <description>Length of time from end of surgery to first oral intake</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="2.6"/>
                    <measurement group_id="O2" value="4.2" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Ambulation</title>
        <description>Length of time from end of surgery to first ambulation</description>
        <time_frame>Day of surgery to post-op day 5</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention-Kidney</title>
            <description>NSS-2-Bridge auricular therapy will be given in addition to standard of care.&#xD;
NSS-2 Bridge: 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>
          </group>
          <group group_id="O2">
            <title>Control-Kidney</title>
            <description>Subject receives standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Ambulation</title>
          <description>Length of time from end of surgery to first ambulation</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" spread="7.4"/>
                    <measurement group_id="O2" value="18.9" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day of surgery through 5 days post-op</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention-Kidney</title>
          <description>NSS-2-Bridge auricular therapy will be given in addition to standard of care.&#xD;
NSS-2 Bridge: 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>
        </group>
        <group group_id="E2">
          <title>Control-Kidney</title>
          <description>No intervention, subject receives 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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Amy Monroe</name_or_title>
      <organization>University of Pittsburgh</organization>
      <phone>412-623-6382</phone>
      <email>monroeal@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/NCT03834142
org study id: STUDY19020023
nct id: NCT03834142
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 change 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
      pain, anxiety and post-operative nausea and vomiting; conditions which are also present
      following major orthopedic surgery such as knee and hip arthroplasties. 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.
An open-label, pilot study will investigate forty individuals, ten of which will be scheduled
      for total hip arthroplasty, ten will be scheduled for total knee arthroplasty, ten scheduled
      for kidney transplant and ten for bariatric surgery, will be approached and consented for
      this trial. Their data in regards to their post-operative pain, nausea, and analgesia use
      will be compared to 10 historic subjects who had the same surgeries in January (TKA/THA) or
      September (kidney transplant/bariatric) of 2019. The subjects who receive the NSS-2-BRIDGE
      will also be monitored for comfort with the device for the tolerability and feasibility of
      utilizing this device in the future to treat post-operative pain.

      Once a patient 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
      joint replacement/kidney transplant/bariatric surgery. Data will be de-identified and kept in
      a locked cabinet in a locked office. The PI and the research coordinator have been trained in
      placing the NSS-2-BRIDGE and will apply the device in the immediate post-operative setting
      (post-anesthesia care unit, PACU). The device will be attached behind the ear with
      double-sided tape. It contains three electrodes which will be applied to the ear and a ground
      which will be placed on the patient's lobe. Each electrode and the ground will be secured
      with adhesive bandages. The patient will be informed at the time of consent and after the
      implantation of the device that they can have the device removed any time after its
      application. Once the device is placed patients will be asked to perform a "pinch test"
      throughout the duration of their time wearing the device. To perform the "pinch test" they
      must pinch down on the electrodes and ground to ensure they are still placed in their
      designated locations and have not come loose.

      As per standard of care, at 24, 48, 72, 96 and 120 hours post-operatively pain scores will be
      collected at rest and movement, total opioid consumption, as well as the devise tolerability.
      Additionally as per other pain pilot IRB approved projects, we shall also collect common
      medical information including time to bowel movement, PONV, time to oral intake (liquid and
      regular diet), time to hospital discharge, intensive care unit (ICU) admission, readmission
      to the hospital, readmission due to pain related issues, quality of recovery after joint
      replacement, 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. If the patient should be discharged prior to 120 hours post-operatively,
      they will be asked to wear the device home. They will also be ask to remove the device at 120
      hours (five days) after device placement and dispose of it in their home. We will provide
      removal instructions. Data post- hospital discharge regarding pain scores, opioid
      consumption, and device tolerability will be collected after discharge by calling the patient
      every day for 120 hr. following the placement of the device.

      At UPMC Shadyside, we expect the patients undergoing primary unilateral either total hip or
      total knee surgery to be discharged on the day of surgery, or the next day but no later than
      48 hrs following surgery. Therefore, for the patients in whom a Bridge device will be placed
      following surgery, it will be possible to document, if during the 120 hrs following the
      placement of the device, the patient returned to the hospital because of pain. This will be
      documented in the patient chart and therefore will be available for review.

      Given that most post-bariatric patients are discharged at 72 hours or before, pain scores,
      opioid needs, and device tolerability at 96 and 120 hours will be collected from the patient
      by calling them after discharge. Participants will be called once daily up until day 5 and
      asked to report information. Phone calls to patients after discharge are consistent with
      routine clinical care. If the kidney transplant patient is discharged prior to 120 hours (5
      days), they will also be called daily to record pain scores, opioid needs, and device
      tolerability for the time they are discharged up to 5 days post-device placement.

      As stated in the protocol, each patient will be discharged according to the standard protocol
      defined by the surgical team. Data collected for both historical and study subjects will be
      the base of the standard clinical data collected for any patient undergoing surgery at UPMC
      SDY, UPMC Montefiore and UPMC MWH. After the patient is discharged from the hospital data
      related to pain, nausea and vomiting and opioid consumption will be obtained by a daily phone
      call.

      The historical controls will include a medical chart review of patients from the Acute
      Perioperative Pain Service at UPMC Shadyside Hospital. Data collection includes total
      narcotic/non-opioid analgesic requirement, pain scores and nausea and vomiting after the
      surgery. Other information collected from the medical record will include age, race and
      medical history. Additionally, we will also collect common medical information including time
      to bowel movement, time to oral intake (liquid and regular diet), time to hospital discharge,
      intensive care unit (ICU) admission, readmission to the hospital, readmission due to pain
      related issues. No Personal Health Identifiers will be collected from the historical
      controls.

      The subjects in whom the Bridge device will be placed will receive the same standard ERAS
      protocol as the patients who will be used as historical control.

      No power analysis will be performed. However, the tolerability of the placement of the bridge
      device (focus of this study) will be assessed using the pain scores.

      We will record pain scores before and after the placement of the Device (prior to leaving the
      recovering room, and at 24, 48, 72, 96 and 120 or until discharge from the hospital) and
      compare it to the historical data of pain scores recorded prior to discharge from the
      hospital.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: 10 subjects will be recruited in each surgical population (hip/knee, kidney, bariatric) to equal 30 total active participants. This will be compared to 10 controls in each surgical population, for a total of 60 participants in the entire pilot.
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of NSS-2 Bridge Device in Changing Perioperative Opioid Consumption
time frame: This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.
description: Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing either a total hip or total knee arthroplasty procedure, bariatric or kidney donor surgeries. Since we are comparing to historical controls, we can only analyze data from when the controls were in the hospital. This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.
measure: Pain Scores
time frame: Day of Surgery, 24 hours post-operative, 48 hours post-operative
description: Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative NRS Pain scores in opioid-naïve patients undergoing either a total hip or total knee arthroplasty, bariatric or kidney donor surgeries. Since we are comparing to historical controls, we can only analyze data from when the controls were in the hospital.
Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. higher scores represent a worse outcome.
measure: Number of Participants With Post-operative Complications
time frame: Day of Surgery through post-operative day 5
description: Investigate the number of participants that experienced post-operative complications .
measure: Level of Comfort Wearing NSS-2 Bridge Device
time frame: Post-operative day 5
description: This was determined by asking the subject "How satisfied were you with the NSS-Bridge Device during the time in which it was worn, with 0 being the worst and 10 being the most satisfied?"
measure: Time to Hospital Discharge
time frame: Day of Surgery to post-op day 5
description: Length of time from end of surgery to discharge from hospital
measure: Time to Discharge From Recovery Room
time frame: Day of Surgery through post-operative day 5
description: Length of time from end of surgery to discharge from the recovery room
measure: Time to Oral Intake
time frame: Day of surgery to post-op day 5
description: Length of time from end of surgery to first oral intake
measure: Time to Ambulation
time frame: Day of surgery to post-op day 5
description: Length of time from end of surgery to first ambulation
arm group label: Intervention
arm group type: Experimental
description: NSS-2-Bridge auricular therapy will be given in addition to standard of care.
arm group label: Control
arm group type: No Intervention
description: No intervention, subject receives standard of care
intervention type: Device
intervention name: NSS-2 Bridge
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.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jacques E Chelly, MD
role: Principal Investigator
affiliation: University of Pittsburgh Medical Center
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Jacques E. Chelly
investigator title: Professor
mesh term: Joint Diseases
mesh term: Pain, Postoperative
mesh term: Acute Pain
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 