<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/NCT03299920</url>
  </required_header>
  <id_info>
    <org_study_id>IRB17-00710</org_study_id>
    <nct_id>NCT03299920</nct_id>
  </id_info>
  <brief_title>Opioid Consumption After Knee Arthroscopy</brief_title>
  <official_title>Opioid Consumption After Knee Arthroscopy With and Without the Use of New Standardized Patient/Family Instructions for Postoperative Analgesic Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Giorgio Veneziano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nationwide Children's Hospital</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 is a prospective, randomized trial of patients undergoing outpatient knee arthroscopy&#xD;
      surgery and receiving a peripheral nerve block. Patients will be randomized to either receive&#xD;
      standard discharge teaching or specialized teaching regarding pain control following a nerve&#xD;
      block. Patients will be asked to complete a journal for 5 days recording their pain scores,&#xD;
      opioid medication usage, and overall satisfaction with pain control at home.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">October 28, 2018</completion_date>
  <primary_completion_date type="Actual">October 22, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of opioid medication doses taken</measure>
    <time_frame>Post-op day 5</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Surgical Procedure, Unspecified</condition>
  <condition>Orthopedic Disorder</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive standardized instruction from a study nurse, tailored to understanding pain management after nerve blocks and maximizing utilization of non-opioid analgesics.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patient will receive conventional instructions on postoperative pain management.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standardized instructions</intervention_name>
    <description>Specific instructions related to peripheral nerve block.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional instructions</intervention_name>
    <description>Usual post-operative instructions.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient of age less than 20 years presenting to NCH main campus for knee arthroscopy&#xD;
&#xD;
          -  American Society of Anesthesiology physical status I or II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anterior cruciate ligament repair or reconstruction&#xD;
&#xD;
          -  Admission to hospital&#xD;
&#xD;
          -  Inability or refusal to receive femoral nerve blockade&#xD;
&#xD;
          -  Body mass index &gt; 99 percentile&#xD;
&#xD;
          -  Hydrocodone allergy or intolerance&#xD;
&#xD;
          -  Acetaminophen allergy or intolerance&#xD;
&#xD;
          -  Non-steroidal anti-inflammatory allergy or intolerance&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Interpreter requirement&#xD;
&#xD;
          -  Opioid use within 3 months prior to surgery&#xD;
&#xD;
          -  Previous knee surgery at WSC after Jan. 1, 2017&#xD;
&#xD;
          -  History of opioid abuse or dependence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giorgio Veneziano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>October 22, 2019</last_update_submitted>
  <last_update_submitted_qc>October 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Giorgio Veneziano</investigator_full_name>
    <investigator_title>Director, Regional Anesthesia Service</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</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/NCT03299920
org study id: IRB17-00710
nct id: NCT03299920
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, randomized trial of patients undergoing outpatient knee arthroscopy
      surgery and receiving a peripheral nerve block. Patients will be randomized to either receive
      standard discharge teaching or specialized teaching regarding pain control following a nerve
      block. Patients will be asked to complete a journal for 5 days recording their pain scores,
      opioid medication usage, and overall satisfaction with pain control at home.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of opioid medication doses taken
time frame: Post-op day 5
arm group label: Intervention
arm group type: Active Comparator
description: Patients will receive standardized instruction from a study nurse, tailored to understanding pain management after nerve blocks and maximizing utilization of non-opioid analgesics.
arm group label: Control
arm group type: Other
description: Patient will receive conventional instructions on postoperative pain management.
intervention type: Other
intervention name: Standardized instructions
description: Specific instructions related to peripheral nerve block.
arm group label: Intervention
intervention type: Other
intervention name: Conventional instructions
description: Usual post-operative instructions.
arm group label: Control
criteria: 
gender: All
minimum age: N/A
maximum age: 20 Years
healthy volunteers: No
last name: Giorgio Veneziano, MD
role: Principal Investigator
affiliation: Nationwide Children's Hospital
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Giorgio Veneziano
investigator title: Director, Regional Anesthesia Service
mesh term: Musculoskeletal Diseases
sharing ipd: No