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/NCT05984433</url>
    </required_header>
    <id_info>
      <org_study_id>H-53820</org_study_id>
      <nct_id>NCT05984433</nct_id>
    </id_info>
    <brief_title>Auricular Acupuncture as Part of Multimodal Analgesia After Lower Leg Fracture</brief_title>
    <official_title>Auricular Acupuncture As Part Of A Multimodal Analgesic Regimen For Reduction Of Opioid Analgesic Use After Surgery To Repair Lower Leg Fractures- 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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose is to find out if incorporation of an intraoperative electro auricular&#xD;
        acupuncture protocol when added to a standard multimodal analgesic regimen for patients&#xD;
        undergoing surgery to repair lower leg fracture under spinal anesthesia will help reduce&#xD;
        postoperative opioid use.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2024</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 Group 2 - no acupuncture 70 patients per group</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The patient will be under sedation during procedure, so will not be aware of whether or not they received acupuncture treatment.&#xD;
  Anesthesia team in the operating room will be aware of treatment. PACU team and outcomes assessor will not be aware of 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 (1-10) 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>Pain, Postoperative</condition>
    <condition>Fracture, Ankle</condition>
    <condition>Pilon Fracture of Tibia</condition>
    <condition>Foot Fracture</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>Auricular acupuncture</intervention_name>
      <description>Electro auricular acupuncture</description>
      <arm_group_label>Electroauricular acupuncture</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patient ages 18-64&#xD;
  &#xD;
            2. American Society of Anesthesiology Physical Status I, II or III&#xD;
  &#xD;
            3. Inpatients scheduled to undergo ankle ORIF at Harris Health System Ben Taub Hospital&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Renal dysfunction (Serum Cr &gt; 1.2) - excluded due to potential altered metabolism of&#xD;
               anesthetic and perioperative medications&#xD;
  &#xD;
            2. Allergy to any of the standard anesthetic agents&#xD;
  &#xD;
            3. Patient inability to properly communicate with investigators (language barrier,&#xD;
               dementia, delirium, psychiatric disorder)&#xD;
  &#xD;
            4. 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_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>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 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>Fractures, Bone</mesh_term>
      <mesh_term>Tibial Fractures</mesh_term>
      <mesh_term>Ankle 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/NCT05984433
  org study id: H-53820
  nct id: NCT05984433
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose is to find out if incorporation of an intraoperative electro auricular
        acupuncture protocol when added to a standard multimodal analgesic regimen for patients
        undergoing surgery to repair lower leg fracture under spinal anesthesia will help reduce
        postoperative opioid use.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled trial. Group 1 - acupuncture Group 2 - no acupuncture 70 patients per group
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: The patient will be under sedation during procedure, so will not be aware of whether or not they received acupuncture treatment.
  Anesthesia team in the operating room will be aware of treatment. PACU team and outcomes assessor will not be aware of 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 (1-10) 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: Auricular acupuncture
  description: Electro auricular acupuncture
  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
  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: Fractures, Bone
  mesh term: Tibial Fractures
  mesh term: Ankle Fractures
  sharing ipd: No