<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/NCT03268278</url>
  </required_header>
  <id_info>
    <org_study_id>UHClevelandMCBupStudy</org_study_id>
    <nct_id>NCT03268278</nct_id>
  </id_info>
  <brief_title>Efficacy of Buprenorphine on Postoperative Endodontic Analgesia</brief_title>
  <acronym>EBPEA</acronym>
  <official_title>Efficacy of Buprenorphine on Postoperative Endodontic Analgesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospitals Cleveland 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To see whether the addition of buprenorphone to local anesthesia will lengthen postoperative&#xD;
      analgesia for endodontic pain&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Loss of interest&#xD;
  </why_stopped>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</primary_completion_date>
  <phase>Phase 1</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Efficacy of Buprenorphine in addition to Local Anesthetic in Providing Prolonged Postoperative Endodontic Analgesia</measure>
    <time_frame>two years</time_frame>
    <description>The number of patients with extended postoperative analgesia when compared to the baseline in pain scores on a visual analog scale during a three-day period will be analyzed. A questionnaire containing a visual analog scale and a log for recording the use of rescue analgesics will be used to gather the data.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>buprenorphine and local anesthetic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>buprenorphine added to local anesthetic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sterile saline and local anesthetic</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>sterile saline (placebo) added to local anesthetic</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buprenorphine</intervention_name>
    <description>Buprenorphine plus local anesthetic</description>
    <arm_group_label>buprenorphine and local anesthetic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sterile saline</intervention_name>
    <description>Placebo 1,8 ml</description>
    <arm_group_label>sterile saline and local anesthetic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lidocaine, epinephrine (Local anesthetic)</intervention_name>
    <description>2% lidocaine 1:100,000 epinephrine</description>
    <arm_group_label>buprenorphine and local anesthetic</arm_group_label>
    <arm_group_label>sterile saline and local anesthetic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  persons with preoperative pain to percussion of a tooth with pulpal disease requiring&#xD;
             endodontic therapy, healthy individuals, ASA Class I and II, no known allergies to the&#xD;
             drugs being administered&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy, allergy to buprenorphine, allergy to local anesthetic&#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>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>April 19, 2019</last_update_submitted>
  <last_update_submitted_qc>April 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospitals Cleveland Medical Center</investigator_affiliation>
    <investigator_full_name>Thomas A. Montagnese</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>analgesia</keyword>
  <keyword>endodontic</keyword>
  <keyword>postoperative</keyword>
  <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>Lidocaine</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Buprenorphine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
    <mesh_term>Anesthetics</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/NCT03268278
org study id: UHClevelandMCBupStudy
nct id: NCT03268278
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
To see whether the addition of buprenorphone to local anesthesia will lengthen postoperative
      analgesia for endodontic pain
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The Efficacy of Buprenorphine in addition to Local Anesthetic in Providing Prolonged Postoperative Endodontic Analgesia
time frame: two years
description: The number of patients with extended postoperative analgesia when compared to the baseline in pain scores on a visual analog scale during a three-day period will be analyzed. A questionnaire containing a visual analog scale and a log for recording the use of rescue analgesics will be used to gather the data.
arm group label: buprenorphine and local anesthetic
arm group type: Active Comparator
description: buprenorphine added to local anesthetic
arm group label: sterile saline and local anesthetic
arm group type: Placebo Comparator
description: sterile saline (placebo) added to local anesthetic
intervention type: Drug
intervention name: Buprenorphine
description: Buprenorphine plus local anesthetic
arm group label: buprenorphine and local anesthetic
intervention type: Drug
intervention name: Sterile saline
description: Placebo 1,8 ml
arm group label: sterile saline and local anesthetic
intervention type: Drug
intervention name: lidocaine, epinephrine (Local anesthetic)
description: 2% lidocaine 1:100,000 epinephrine
arm group label: buprenorphine and local anesthetic
arm group label: sterile saline and local anesthetic
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University Hospitals Cleveland Medical Center
investigator full name: Thomas A. Montagnese
investigator title: Associate Professor
mesh term: Pain, Postoperative
mesh term: Lidocaine
mesh term: Epinephrine
mesh term: Buprenorphine
mesh term: Anesthetics, Local
mesh term: Anesthetics
sharing ipd: No