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/NCT06042608</url>
    </required_header>
    <id_info>
      <org_study_id>STU-2023-0163</org_study_id>
      <nct_id>NCT06042608</nct_id>
    </id_info>
    <brief_title>Evaluating Intercostobrachial Nerve Block's Effect on Pain Control After Shoulder Replacement</brief_title>
    <official_title>Effect of Adding an Intercostobrachial Nerve Block to an Interscalene Block on Postoperative Pain After Total Shoulder Arthroplasty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Texas Southwestern Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Texas Southwestern Medical Center</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>
        Interscalene blocks are frequently performed to decrease postoperative pain after shoulder&#xD;
        surgeries and are considered the gold standard for pain control after this type of surgery.&#xD;
        Some patients report pain in the axilla (armpit) following shoulder replacement surgeries.&#xD;
        Sensation in the axilla is supplied by nerves not covered by the interscalene block.&#xD;
        Sensation in the axilla can be decreased by performing an intercostobrachial nerve block.&#xD;
        This study aims to study whether adding an intercostobrachial nerve block to the interscalene&#xD;
        block decreases recovery room stay time, opioid pain medication requirement, and&#xD;
        postoperative pain scores.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 1, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>time spent in PACU (recovery room)</measure>
      <time_frame>0-2 hours after surgery</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>amount of opioid pain medications required to control postoperative pain</measure>
      <time_frame>0-3 days after surgery</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>pain scores (1-10 out of 10)</measure>
      <time_frame>0-3 days after surgery</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">74</enrollment>
    <condition>Postoperative Pain, Acute</condition>
    <condition>Shoulder Pain</condition>
    <arm_group>
      <arm_group_label>Active intercostobrachial nerve block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patient will receive local anesthetic injected around their intercostobrachial nerve in the axilla (armpit). They will still receive an active interscalene nerve block (gold standard) that helps with the rest of the shoulder pain.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham intercostobrachial nerve block</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patient will receive saline injected around their intercostobrachial nerve in the axilla (armpit). This is a sham intercostobrachial nerve block because saline is not an active medication. They will still receive an active interscalene nerve block (gold standard) that helps with the rest of the shoulder pain.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>intercostobrachial nerve block</intervention_name>
      <description>injection of local anesthetic to target the intercostobrachial nerve in the axilla</description>
      <arm_group_label>Active intercostobrachial nerve block</arm_group_label>
      <arm_group_label>Sham intercostobrachial nerve block</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients 18-70 years old&#xD;
  &#xD;
            -  Adult patient's BMI &lt; 35&#xD;
  &#xD;
            -  Individuals presenting for primary total shoulder arthroplasty or reverse total&#xD;
               shoulder arthroplasty&#xD;
  &#xD;
            -  Anticipated discharge home same day of surgery&#xD;
  &#xD;
            -  Patient is able to provide informed consent to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient presenting for revision shoulder surgery&#xD;
  &#xD;
            -  Allergy to amide local anesthetic, liposomal bupivacaine or other medication involving&#xD;
               liposomal formulation&#xD;
  &#xD;
            -  Preexisting neurological deficits involving or potentially involving the ipsilateral&#xD;
               brachial plexus&#xD;
  &#xD;
            -  Preexisting contralateral vocal fold paralysis or recurrent laryngeal paralysis&#xD;
  &#xD;
            -  Psychiatric or cognitive disorders that could interfere with perioperative evaluation&#xD;
               including drug or alcohol abuse&#xD;
  &#xD;
            -  Chronic pain conditions&#xD;
  &#xD;
            -  Preoperative opioid use&#xD;
  &#xD;
            -  Moderate to severe pulmonary disease&#xD;
  &#xD;
            -  Moderate to severe sleep apnea&#xD;
  &#xD;
            -  Planned postoperative admission.&#xD;
  &#xD;
            -  Unplanned postoperative admission&#xD;
  &#xD;
            -  Any contraindication to interscalene or intercostobrachial nerve block including any&#xD;
               local disorder of the skin where blockade is to be performed which would prevent safe&#xD;
               performance of the block&#xD;
  &#xD;
            -  Any coagulation abnormality which would be a contraindication for block placement&#xD;
  &#xD;
            -  Preoperative chronic renal dysfunction requiring renal replacement therapy or CrCl &lt;&#xD;
               60&#xD;
  &#xD;
            -  Sulfa allergy (or other reason patient cannot receive celecoxib)&#xD;
  &#xD;
            -  Allergy or intolerance to any medication in the protocol&#xD;
  &#xD;
            -  Body mass index &gt;35&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Incarceration&#xD;
  &#xD;
            -  ASA classification greater than 3&#xD;
  &#xD;
            -  Inability to provide informed consent&#xD;
  &#xD;
            -  Refusal to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Lisa Gu</last_name>
      <phone>214-648-6400</phone>
      <email>lisa.gu@utsouthwestern.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
      <investigator_full_name>Lisa Gu</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Shoulder Pain</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>
    <!-- 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/NCT06042608
  org study id: STU-2023-0163
  nct id: NCT06042608
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Interscalene blocks are frequently performed to decrease postoperative pain after shoulder
        surgeries and are considered the gold standard for pain control after this type of surgery.
        Some patients report pain in the axilla (armpit) following shoulder replacement surgeries.
        Sensation in the axilla is supplied by nerves not covered by the interscalene block.
        Sensation in the axilla can be decreased by performing an intercostobrachial nerve block.
        This study aims to study whether adding an intercostobrachial nerve block to the interscalene
        block decreases recovery room stay time, opioid pain medication requirement, and
        postoperative pain scores.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  measure: time spent in PACU (recovery room)
  time frame: 0-2 hours after surgery
  measure: amount of opioid pain medications required to control postoperative pain
  time frame: 0-3 days after surgery
  measure: pain scores (1-10 out of 10)
  time frame: 0-3 days after surgery
  arm group label: Active intercostobrachial nerve block
  arm group type: Active Comparator
  description: Patient will receive local anesthetic injected around their intercostobrachial nerve in the axilla (armpit). They will still receive an active interscalene nerve block (gold standard) that helps with the rest of the shoulder pain.
  arm group label: Sham intercostobrachial nerve block
  arm group type: Placebo Comparator
  description: Patient will receive saline injected around their intercostobrachial nerve in the axilla (armpit). This is a sham intercostobrachial nerve block because saline is not an active medication. They will still receive an active interscalene nerve block (gold standard) that helps with the rest of the shoulder pain.
  intervention type: Procedure
  intervention name: intercostobrachial nerve block
  description: injection of local anesthetic to target the intercostobrachial nerve in the axilla
  arm group label: Active intercostobrachial nerve block
  arm group label: Sham intercostobrachial nerve block
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lisa Gu
  phone: 214-648-6400
  email: lisa.gu@utsouthwestern.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Texas Southwestern Medical Center
  investigator full name: Lisa Gu
  investigator title: Assistant Professor
  mesh term: Shoulder Pain
  mesh term: Pain, Postoperative
  mesh term: Acute Pain
  sharing ipd: No