<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/NCT02970383</url>
  </required_header>
  <id_info>
    <org_study_id>MMR-CT-1</org_study_id>
    <nct_id>NCT02970383</nct_id>
  </id_info>
  <brief_title>Narcotic Use After Minor Hand Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carilion Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carilion Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effect of larger or smaller opioid prescriptions following minor&#xD;
      surgery on the amount of narcotic used, patient reported satisfaction, refill requests, and&#xD;
      leftover narcotic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients are randomized to receive prescriptions for either 10 or 30 tabs of 5 mg&#xD;
      hydrocodone/325 mg acetaminophen following minor hand surgery. Patients are allowed to&#xD;
      request additional medication as needed. Patients are contacted by phone 10-14 days after&#xD;
      their surgery to answer a questionnaire regarding number of pills taken, number of refills&#xD;
      requested, number of remaining pills, their satisfaction with their pain control and their&#xD;
      surgery, and their opinion regarding the appropriateness of the prescription size.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Narcotic used</measure>
    <time_frame>10-14 days post-op</time_frame>
    <description>number of narcotic tabs taken by patient (5mg hydrocodone/325 mg acetaminophen)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of refills requested</measure>
    <time_frame>10-14 days post-op</time_frame>
    <description>number of times patient requested additional pain medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of left over tabs</measure>
    <time_frame>10-14 days post-op</time_frame>
    <description>Number of left over usable narcotic tabs remaining in patient possession</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported efficacy of pain control</measure>
    <time_frame>10-14 days post-op</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported satisfaction with pain control</measure>
    <time_frame>10-14 days post-op</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported satisfaction with overall surgical experience</measure>
    <time_frame>10-14 days post-op</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Opinion Regarding Appropriateness of Size of Initial Prescription</measure>
    <time_frame>10-14 days post-op</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Minor Surgical Procedures</condition>
  <condition>Narcotics Use</condition>
  <arm_group>
    <arm_group_label>10 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initial prescription for 10 narcotic tabs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30 group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Initial prescription for 30 narcotic tabs</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Initial prescription for 10 narcotic tabs</intervention_name>
    <description>Reduced number of pills in initial prescription post-operatively</description>
    <arm_group_label>10 group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Inital prescription for 30 narcotic tabs</intervention_name>
    <arm_group_label>30 group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing minor hand surgery by a participating surgeon within the study&#xD;
             period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  narcotic use within previous 3 months&#xD;
&#xD;
          -  concurrent procedure&#xD;
&#xD;
          -  acute trauma&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  allergy or other contraindication or intolerance to hydrocodone or acetaminophen&#xD;
&#xD;
          -  post-operative complications&#xD;
&#xD;
          -  inability to provide personal consent to the procedure or the research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cassandra Mierisch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carilion Clinic</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>November 18, 2016</last_update_submitted>
  <last_update_submitted_qc>November 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Carilion Clinic</investigator_affiliation>
    <investigator_full_name>Cassandra Mierisch</investigator_full_name>
    <investigator_title>Orthopedic Surgeon</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Narcotics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>none currently</ipd_description>
  </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/NCT02970383
org study id: MMR-CT-1
nct id: NCT02970383
lead sponsor: 
has dmc: No
This study evaluates the effect of larger or smaller opioid prescriptions following minor
      surgery on the amount of narcotic used, patient reported satisfaction, refill requests, and
      leftover narcotic.
Patients are randomized to receive prescriptions for either 10 or 30 tabs of 5 mg
      hydrocodone/325 mg acetaminophen following minor hand surgery. Patients are allowed to
      request additional medication as needed. Patients are contacted by phone 10-14 days after
      their surgery to answer a questionnaire regarding number of pills taken, number of refills
      requested, number of remaining pills, their satisfaction with their pain control and their
      surgery, and their opinion regarding the appropriateness of the prescription size.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Narcotic used
time frame: 10-14 days post-op
description: number of narcotic tabs taken by patient (5mg hydrocodone/325 mg acetaminophen)
measure: Number of refills requested
time frame: 10-14 days post-op
description: number of times patient requested additional pain medication
measure: Number of left over tabs
time frame: 10-14 days post-op
description: Number of left over usable narcotic tabs remaining in patient possession
measure: Patient reported efficacy of pain control
time frame: 10-14 days post-op
measure: Patient reported satisfaction with pain control
time frame: 10-14 days post-op
measure: Patient reported satisfaction with overall surgical experience
time frame: 10-14 days post-op
measure: Patient Opinion Regarding Appropriateness of Size of Initial Prescription
time frame: 10-14 days post-op
arm group label: 10 group
arm group type: Experimental
description: Initial prescription for 10 narcotic tabs
arm group label: 30 group
arm group type: Active Comparator
description: Initial prescription for 30 narcotic tabs
intervention type: Behavioral
intervention name: Initial prescription for 10 narcotic tabs
description: Reduced number of pills in initial prescription post-operatively
arm group label: 10 group
intervention type: Behavioral
intervention name: Inital prescription for 30 narcotic tabs
arm group label: 30 group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Cassandra Mierisch, MD
role: Principal Investigator
affiliation: Carilion Clinic
responsible party type: Principal Investigator
investigator affiliation: Carilion Clinic
investigator full name: Cassandra Mierisch
investigator title: Orthopedic Surgeon
mesh term: Pain, Postoperative
mesh term: Narcotics
sharing ipd: No
ipd description: none currently