<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/NCT03808025</url>
  </required_header>
  <id_info>
    <org_study_id>1333215</org_study_id>
    <nct_id>NCT03808025</nct_id>
  </id_info>
  <brief_title>Opioid Use in Shoulder Arthroplasty Patients: A Stratification and Algorithm</brief_title>
  <official_title>Opioid Use in Shoulder Arthroplasty Patients: A Stratification and Algorithm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</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 investigators aim to better understand opioid use in patients undergoing elective&#xD;
      shoulder surgery. The investigators will prospectively determine actual postoperative opioid&#xD;
      use, while evaluating whether implementation of an educational session with pain contract&#xD;
      would help minimize opioid use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aim to better understand opioid use in patients undergoing elective&#xD;
      shoulder surgery. As part of a multi-part investigation, The investigators intend to&#xD;
      prospectively determine actual postoperative opioid use, while evaluating whether&#xD;
      implementation of an educational session with pain contract would help minimize opioid use.&#xD;
      Through use of a teaching session and pain contract, it is hypothesized opioid use would&#xD;
      decrease. The investigators hypothesize the use of a pain contract and thorough discussion&#xD;
      regarding proper opioid use and side-effects, will decrease the amount of postoperative&#xD;
      opioid use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Actual">May 4, 2023</completion_date>
  <primary_completion_date type="Actual">May 4, 2023</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Patients who consent to the study will be prospectively randomized to one of two arms: one will receive educational intervention, the other will not. Investigators will be masked to patient intervention when assessing and collecting outcomes.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid use</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Total opioid use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of refills</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Necessary refills related to surgical pain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The teaching arm would consist of a standardized dialogue the surgeon will complete with the patient in order to familiarize the patient with the risks of over-prescribing opioid medication and set patient expectations regarding the clinic's opioid prescribing pattern protocol, in an effort to minimize the number of opioid pills prescribed or refills required, the amount actually used, and the untoward side effects of opioid use (e.g. respiratory depression, nausea, sedation, restriction from driving, and access to and use by those the medication was not intended).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no education</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard preoperative care without dedicated teaching regarding opioid use and risks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>opioid education</intervention_name>
    <description>see arm/group descriptions</description>
    <arm_group_label>education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older with capacity to consent&#xD;
&#xD;
          -  presenting to UC Davis Medical Center Department of Orthopedic Surgery and planning to&#xD;
             undergo elective shoulder surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to consent&#xD;
&#xD;
          -  prisoners&#xD;
&#xD;
          -  children&#xD;
&#xD;
          -  pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert M Szabo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Davis Department of Orthopaedic Surgery</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://studypages.com/s/a-study-of-opioid-use-in-shoulder-arthroplasty-patients-139543/</url>
    <description>Learn more or sign up for the study here!</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 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>Analgesics, Opioid</mesh_term>
  </intervention_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/NCT03808025
org study id: 1333215
nct id: NCT03808025
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The investigators aim to better understand opioid use in patients undergoing elective
      shoulder surgery. The investigators will prospectively determine actual postoperative opioid
      use, while evaluating whether implementation of an educational session with pain contract
      would help minimize opioid use.
The investigators aim to better understand opioid use in patients undergoing elective
      shoulder surgery. As part of a multi-part investigation, The investigators intend to
      prospectively determine actual postoperative opioid use, while evaluating whether
      implementation of an educational session with pain contract would help minimize opioid use.
      Through use of a teaching session and pain contract, it is hypothesized opioid use would
      decrease. The investigators hypothesize the use of a pain contract and thorough discussion
      regarding proper opioid use and side-effects, will decrease the amount of postoperative
      opioid use.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Patients who consent to the study will be prospectively randomized to one of two arms: one will receive educational intervention, the other will not. Investigators will be masked to patient intervention when assessing and collecting outcomes.
measure: Opioid use
time frame: 6 months after surgery
description: Total opioid use
measure: Number of refills
time frame: 6 months after surgery
description: Necessary refills related to surgical pain
arm group label: education
arm group type: Experimental
description: The teaching arm would consist of a standardized dialogue the surgeon will complete with the patient in order to familiarize the patient with the risks of over-prescribing opioid medication and set patient expectations regarding the clinic's opioid prescribing pattern protocol, in an effort to minimize the number of opioid pills prescribed or refills required, the amount actually used, and the untoward side effects of opioid use (e.g. respiratory depression, nausea, sedation, restriction from driving, and access to and use by those the medication was not intended).
arm group label: no education
arm group type: No Intervention
description: Standard preoperative care without dedicated teaching regarding opioid use and risks
intervention type: Behavioral
intervention name: opioid education
description: see arm/group descriptions
arm group label: education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robert M Szabo, MD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
country: United States
url: https://studypages.com/s/a-study-of-opioid-use-in-shoulder-arthroplasty-patients-139543/
description: Learn more or sign up for the study here!
responsible party type: Sponsor
mesh term: Analgesics, Opioid
sharing ipd: No