<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/NCT03750357</url>
  </required_header>
  <id_info>
    <org_study_id>PR2-POPS-18</org_study_id>
    <secondary_id>CS/PRv2.0/01/2018</secondary_id>
    <nct_id>NCT03750357</nct_id>
  </id_info>
  <brief_title>Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Post Operative Pain Solution(POPS) - Cardiac Surgery</brief_title>
  <acronym>POPS</acronym>
  <official_title>Percutaneous Electrical Nerve Stimulation (PENS) of the Auricle for Acute Pain Management Post Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DyAnsys, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DyAnsys, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Percutaneous Electrical Nerve Stimulation (PENS) of the auricle for acute pain management&#xD;
      post cardiac surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A well formulated analgesic protocol is fundamental to fast tracking post cardiac surgery.&#xD;
      Traditional analgesic methods have their own set of drawbacks unique to cardiac surgery.&#xD;
      Opioids have well established side effects like nausea, vomiting, respiratory depression,&#xD;
      urinary retention. Regional anesthetic techniques in anti coagulated patients may result in&#xD;
      potentially catastrophic neurological, bleeding and thromboembolic sequelae. Non steroidal&#xD;
      Anti Inflammatory Drugs (NSAIDs) have been associated with increased cerebrovascular events,&#xD;
      renal dysfunction, sternal wound infections. These make alternative therapies, including non&#xD;
      pharmacological modalities, attractive options for optimal analgesic therapy during the post&#xD;
      operative period.&#xD;
&#xD;
      Alternative methods like topical application of COX -2 inhibitors, intravenous magnesium,&#xD;
      Transcutaneous Electrical Nerve Stimulation (TENS) have been tried with varied results in&#xD;
      cardiac surgery. A somatotopic relationship has been described between the auricle and the&#xD;
      other anatomical regions of the body. When specific points are accurately identified along&#xD;
      the meridians of the ear and stimulated electrically, analgesic effects are known to occur.&#xD;
      Percutaneous Electrical Nerve Stimulation (PENS) of the auricle and its efficacy in&#xD;
      management of post midline sternotomy pain has not been evaluated previously. Primary Relief&#xD;
      v 2.0 is a device which provides continuous PENS aimed at non pharmacological post operative&#xD;
      pain management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2018</start_date>
  <completion_date type="Actual">December 17, 2018</completion_date>
  <primary_completion_date type="Actual">November 17, 2018</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PAIN Relief by physical examination by HCP</measure>
    <time_frame>After 2 hours of device activation</time_frame>
    <description>Relief of pain when the dosage of the anesthesia level gradually decreases after the surgery completion. This is measured by physical interaction with the patient by the health care provider.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Post Operative Pain</condition>
  <condition>Midline Sternotomy Incision</condition>
  <arm_group>
    <arm_group_label>Primary Relief v 2.0 with Paracetamol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A will be treated with Primary Relief v 2.0(1 - 100Hz) sweep stimulation with increase in power of the stimulation for fixed interval of time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Only Paracetamol</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group B will be treated with paracetamol drug.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Primary Relief v 2.0</intervention_name>
    <description>To prove the effectiveness of Post Operative Pain Solution using Primary relief v 2.0 by Percutaneous Electrical Nerve Stimulation in the auricle.</description>
    <arm_group_label>Primary Relief v 2.0 with Paracetamol</arm_group_label>
    <other_name>Neurostimulator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cardiac surgery patient with midline sternotomy incision&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Thoracotomy incisions&#xD;
&#xD;
          2. Patients with pacemakers,&#xD;
&#xD;
          3. Post operative cognitive dysfunction&#xD;
&#xD;
          4. Anticipated ventilation &gt; 24 hrs&#xD;
&#xD;
          5. Pre operative opioid therapy&#xD;
&#xD;
          6. Ear infections&#xD;
&#xD;
          7. Skin lesions / allergy to adhesive materials&#xD;
&#xD;
          8. Re-exploration for any reason&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rohini M Balaji, MBBS., DNB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sri Jayadeva Institue of Cardiovascular Science and Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sri Jayadeva Institute of cardiovascular Science and Research</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560069</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiac surgery pain reduction</keyword>
  <keyword>Post operative pain</keyword>
  <keyword>PENS</keyword>
  <keyword>Neurostimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03750357
org study id: PR2-POPS-18
secondary id: CS/PRv2.0/01/2018
nct id: NCT03750357
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Percutaneous Electrical Nerve Stimulation (PENS) of the auricle for acute pain management
      post cardiac surgery
A well formulated analgesic protocol is fundamental to fast tracking post cardiac surgery.
      Traditional analgesic methods have their own set of drawbacks unique to cardiac surgery.
      Opioids have well established side effects like nausea, vomiting, respiratory depression,
      urinary retention. Regional anesthetic techniques in anti coagulated patients may result in
      potentially catastrophic neurological, bleeding and thromboembolic sequelae. Non steroidal
      Anti Inflammatory Drugs (NSAIDs) have been associated with increased cerebrovascular events,
      renal dysfunction, sternal wound infections. These make alternative therapies, including non
      pharmacological modalities, attractive options for optimal analgesic therapy during the post
      operative period.

      Alternative methods like topical application of COX -2 inhibitors, intravenous magnesium,
      Transcutaneous Electrical Nerve Stimulation (TENS) have been tried with varied results in
      cardiac surgery. A somatotopic relationship has been described between the auricle and the
      other anatomical regions of the body. When specific points are accurately identified along
      the meridians of the ear and stimulated electrically, analgesic effects are known to occur.
      Percutaneous Electrical Nerve Stimulation (PENS) of the auricle and its efficacy in
      management of post midline sternotomy pain has not been evaluated previously. Primary Relief
      v 2.0 is a device which provides continuous PENS aimed at non pharmacological post operative
      pain management.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: PAIN Relief by physical examination by HCP
time frame: After 2 hours of device activation
description: Relief of pain when the dosage of the anesthesia level gradually decreases after the surgery completion. This is measured by physical interaction with the patient by the health care provider.
arm group label: Primary Relief v 2.0 with Paracetamol
arm group type: Experimental
description: Group A will be treated with Primary Relief v 2.0(1 - 100Hz) sweep stimulation with increase in power of the stimulation for fixed interval of time.
arm group label: Only Paracetamol
arm group type: No Intervention
description: Group B will be treated with paracetamol drug.
intervention type: Device
intervention name: Primary Relief v 2.0
description: To prove the effectiveness of Post Operative Pain Solution using Primary relief v 2.0 by Percutaneous Electrical Nerve Stimulation in the auricle.
arm group label: Primary Relief v 2.0 with Paracetamol
other name: Neurostimulator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Rohini M Balaji, MBBS., DNB
role: Principal Investigator
affiliation: Sri Jayadeva Institue of Cardiovascular Science and Research
facility: 
country: India
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: No