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/NCT06023329</url>
    </required_header>
    <id_info>
      <org_study_id>CPB</org_study_id>
      <nct_id>NCT06023329</nct_id>
    </id_info>
    <brief_title>Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery</brief_title>
    <official_title>Superficial Cervical Plexus Block for Improved Outcomes in Pediatric Otolaryngologic Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Minnesota</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Minnesota</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Literature on the use of superficial cervical plexus blocks for ear surgery is sparse in&#xD;
        general, and almost non-existent in the pediatric population. Overall, literature review&#xD;
        supports the safety of performance of this block but there is minimal published literature on&#xD;
        its utility despite anecdotal evidence of benefit. This study, especially its prospective&#xD;
        randomized nature will allow for expansion of the evidence for or against addition of this&#xD;
        block to the care of pediatric patients undergoing ear surgery. The purpose of this study is&#xD;
        to determine if SCPB plus standard practices provides superior pain control, as measured by&#xD;
        reduced opiate consumption, compared to standard practices alone when performed on pediatric&#xD;
        patients undergoing surgery on the ear and mastoid process.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2025</primary_completion_date>
    <phase>Phase 4</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>Supportive Care</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Opioid use</measure>
      <time_frame>30 days post surgery</time_frame>
      <description>measured on a MME per kilogram</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>intraoperative opiate use</measure>
      <time_frame>30 days post surgery</time_frame>
      <description>Assessed via chart review of opiate administration on an MME basis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>post-operative opiate use</measure>
      <time_frame>30 days post surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain level</measure>
      <time_frame>30 days post surgery</time_frame>
      <description>Pain level will be assessed via total pain scores via either FLACC or Wong-Baker Faces, both are pain scales from 0-10, 0 being no pain and 10 being the worst pain imaginable. These scales are interchangeable and will allow both patients who can read and younger patients who cannot read to rate their pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Recovery</measure>
      <time_frame>30 days post surgery</time_frame>
      <description>Assessed via modified version of the quality of recovery survey. The quality of recovery scale is a validated document for assessing recovery after surgery. The study will use a modified version of this with language changed for parental assessment of Quality of recovery, but the same questions and scale are used.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post Anesthesia Care Unit anti-emetic use</measure>
      <time_frame>30 days post surgery</time_frame>
      <description>Assessed via chart review of post-operative care unit medication administration</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Otolaryngologic Surgery</condition>
    <arm_group>
      <arm_group_label>Group1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ropivacaine</intervention_name>
      <description>will receive SCPB with ropivacaine via regional anesthesia team</description>
      <arm_group_label>Group1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Saline</intervention_name>
      <description>will receive SCPB with saline via regional anesthesia team</description>
      <arm_group_label>Group 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age: &lt;18 years and &gt;3 months&#xD;
  &#xD;
            -  Surgical procedure: Unilateral cochlear implant or tympanomastoidectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Preoperative opiate use within the last 30 days&#xD;
  &#xD;
            -  Bilateral surgery&#xD;
  &#xD;
            -  No English speaking caregiver&#xD;
  &#xD;
            -  Parental/patient refusal&#xD;
  &#xD;
            -  Severe preoperative respiratory compromise&#xD;
  &#xD;
            -  Allergy to ropivacaine&#xD;
  &#xD;
            -  Coagulopathy: Defined by INR&amp;gt;1.5 or Platelet count &amp;lt;100k&#xD;
  &#xD;
            -  Current Infection at site of injection&#xD;
  &#xD;
            -  VP Shunt on side of surgical procedure&#xD;
  &#xD;
            -  Pregnant patients: determined by patient history and available laboratory data.&#xD;
               Patients will not be required to have pregnancy testing done if not otherwise&#xD;
               indicated.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Months</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Benjamin Fuller, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Minnesota</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Candace Nelson</last_name>
      <email>nelso377@umn.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Minnesota</name>
        <address>
          <city>Minneapolis</city>
          <state>Minnesota</state>
          <zip>55455</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Candace Nelson</last_name>
        <email>nelso377@umn.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ropivacaine</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06023329
  org study id: CPB
  nct id: NCT06023329
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  Literature on the use of superficial cervical plexus blocks for ear surgery is sparse in
        general, and almost non-existent in the pediatric population. Overall, literature review
        supports the safety of performance of this block but there is minimal published literature on
        its utility despite anecdotal evidence of benefit. This study, especially its prospective
        randomized nature will allow for expansion of the evidence for or against addition of this
        block to the care of pediatric patients undergoing ear surgery. The purpose of this study is
        to determine if SCPB plus standard practices provides superior pain control, as measured by
        reduced opiate consumption, compared to standard practices alone when performed on pediatric
        patients undergoing surgery on the ear and mastoid process.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Opioid use
  time frame: 30 days post surgery
  description: measured on a MME per kilogram
  measure: intraoperative opiate use
  time frame: 30 days post surgery
  description: Assessed via chart review of opiate administration on an MME basis
  measure: post-operative opiate use
  time frame: 30 days post surgery
  measure: Pain level
  time frame: 30 days post surgery
  description: Pain level will be assessed via total pain scores via either FLACC or Wong-Baker Faces, both are pain scales from 0-10, 0 being no pain and 10 being the worst pain imaginable. These scales are interchangeable and will allow both patients who can read and younger patients who cannot read to rate their pain.
  measure: Quality of Recovery
  time frame: 30 days post surgery
  description: Assessed via modified version of the quality of recovery survey. The quality of recovery scale is a validated document for assessing recovery after surgery. The study will use a modified version of this with language changed for parental assessment of Quality of recovery, but the same questions and scale are used.
  measure: Post Anesthesia Care Unit anti-emetic use
  time frame: 30 days post surgery
  description: Assessed via chart review of post-operative care unit medication administration
  arm group label: Group1
  arm group type: Experimental
  arm group label: Group 2
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: ropivacaine
  description: will receive SCPB with ropivacaine via regional anesthesia team
  arm group label: Group1
  intervention type: Drug
  intervention name: Saline
  description: will receive SCPB with saline via regional anesthesia team
  arm group label: Group 2
  criteria: 
  gender: All
  minimum age: 3 Months
  maximum age: 18 Years
  healthy volunteers: No
  last name: Benjamin Fuller, MD
  role: Principal Investigator
  affiliation: University of Minnesota
  last name: Candace Nelson
  email: nelso377@umn.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Ropivacaine