xml: <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/NCT05974254</url>
    </required_header>
    <id_info>
      <org_study_id>H-53875</org_study_id>
      <nct_id>NCT05974254</nct_id>
    </id_info>
    <brief_title>Auricular Acupuncture As Part Of A Multimodal Regimen After Distal Radius Open Reduction and Internal Fixation</brief_title>
    <official_title>Auricular Acupuncture As Part Of A Multimodal Regimen For Reduction Of Opioid Analgesic Use After Distal Radius Open Reduction and Internal Fixation- A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Baylor College of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Baylor College of Medicine</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>
        This randomized controlled trial will test the hypothesis that patients receiving an&#xD;
        intraoperative auricular acupuncture protocol will require less postoperative opioid&#xD;
        analgesic use compared to those who do not receive acupuncture in the setting of a multimodal&#xD;
        analgesic protocol for patients receiving surgery to repair distal radius fractures at a&#xD;
        Level 1 trauma center under brachial plexus anesthesia with sedation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Randomized controlled trial Group 1 - acupuncture treatment Group 2 - no acupuncture treatment 70 patients per group</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The patients will be under sedation in the operating room and will not be aware of which treatment group they are in.&#xD;
  The PACU team and outcomes assessor will not be aware of patient group assignment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Total opioid analgesic use for 14 days after surgery</measure>
      <time_frame>14 days</time_frame>
      <description>Total opioid given in hospital and taken at home, converted to oral morphine equivalents</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain scores</measure>
      <time_frame>14 days</time_frame>
      <description>Pain scores in PACU and at the 7 and 14 day mark post surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of side effects associated with opioid use</measure>
      <time_frame>14 days</time_frame>
      <description>PONV, pruritus, headache, constipation, urinary retention, fatigue, difficulty with concentration, drowsiness, lightheadedness, dry mouth</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">140</enrollment>
    <condition>Radius Fracture Distal</condition>
    <condition>Pain, Postoperative</condition>
    <arm_group>
      <arm_group_label>Electroauricular acupuncture</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Immediately after Level 2 sedation is achieved, an enhanced auricular trauma protocol (ATP) will be administered on the ear ipsilateral to the operative side at 8 ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) as described by Cheng (2022). The original ATP was described by Helms (2011). Seirin L 0.2 x 30 mm needles will be placed at Hypothalamus and Shen Men points. Seirin J 0.18 x 15 mm needles will be placed at Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Vagus, and Insula points. Electrostimulation using an ITO ES 130 microstimulator at 30 HZ with Level 4 intensity, will be applied with the positive lead (red) on Hypothalamus and negative lead (black) at Shen Men for 60 minutes. All needles will be removed 1 hour after insertion.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No acupuncture</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No acupuncture treatment given</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Acupuncture</intervention_name>
      <description>Electroacupuncture</description>
      <arm_group_label>Electroauricular acupuncture</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient ages 18-64&#xD;
  &#xD;
            -  American Society of Anesthesiologists Physical Status 1, 2, or 3&#xD;
  &#xD;
            -  Patients scheduled to undergo distal radius ORIF under brachial plexus nerve block&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Renal dysfunction (Serum Cr &gt; 1.2) - excluded due to potential for altered metabolism&#xD;
               of anesthetic and perioperative medications&#xD;
  &#xD;
            -  Allergy to any of the standard anesthetic agents&#xD;
  &#xD;
            -  Patient inability to properly communicate with investigators&#xD;
  &#xD;
            -  Patient or surgeon refusal&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jaime Ortiz, MD, MBA</last_name>
      <role>Principal Investigator</role>
      <affiliation>Baylor College of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jaime Ortiz, MD, MBA</last_name>
      <phone>713-873-2860</phone>
      <email>jaimeo@bcm.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
      <investigator_full_name>Jaime Ortiz</investigator_full_name>
      <investigator_title>Professor of Anesthesiology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Radius Fractures</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974254
  org study id: H-53875
  nct id: NCT05974254
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This randomized controlled trial will test the hypothesis that patients receiving an
        intraoperative auricular acupuncture protocol will require less postoperative opioid
        analgesic use compared to those who do not receive acupuncture in the setting of a multimodal
        analgesic protocol for patients receiving surgery to repair distal radius fractures at a
        Level 1 trauma center under brachial plexus anesthesia with sedation.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled trial Group 1 - acupuncture treatment Group 2 - no acupuncture treatment 70 patients per group
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: The patients will be under sedation in the operating room and will not be aware of which treatment group they are in.
  The PACU team and outcomes assessor will not be aware of patient group assignment.
  measure: Total opioid analgesic use for 14 days after surgery
  time frame: 14 days
  description: Total opioid given in hospital and taken at home, converted to oral morphine equivalents
  measure: Pain scores
  time frame: 14 days
  description: Pain scores in PACU and at the 7 and 14 day mark post surgery
  measure: Incidence of side effects associated with opioid use
  time frame: 14 days
  description: PONV, pruritus, headache, constipation, urinary retention, fatigue, difficulty with concentration, drowsiness, lightheadedness, dry mouth
  arm group label: Electroauricular acupuncture
  arm group type: Experimental
  description: Immediately after Level 2 sedation is achieved, an enhanced auricular trauma protocol (ATP) will be administered on the ear ipsilateral to the operative side at 8 ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) as described by Cheng (2022). The original ATP was described by Helms (2011). Seirin L 0.2 x 30 mm needles will be placed at Hypothalamus and Shen Men points. Seirin J 0.18 x 15 mm needles will be placed at Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Vagus, and Insula points. Electrostimulation using an ITO ES 130 microstimulator at 30 HZ with Level 4 intensity, will be applied with the positive lead (red) on Hypothalamus and negative lead (black) at Shen Men for 60 minutes. All needles will be removed 1 hour after insertion.
  arm group label: No acupuncture
  arm group type: No Intervention
  description: No acupuncture treatment given
  intervention type: Device
  intervention name: Acupuncture
  description: Electroacupuncture
  arm group label: Electroauricular acupuncture
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: No
  last name: Jaime Ortiz, MD, MBA
  role: Principal Investigator
  affiliation: Baylor College of Medicine
  last name: Jaime Ortiz, MD, MBA
  phone: 713-873-2860
  email: jaimeo@bcm.edu
  responsible party type: Principal Investigator
  investigator affiliation: Baylor College of Medicine
  investigator full name: Jaime Ortiz
  investigator title: Professor of Anesthesiology
  mesh term: Pain, Postoperative
  mesh term: Radius Fractures
  sharing ipd: No