<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/NCT03757715</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300000567</org_study_id>
    <nct_id>NCT03757715</nct_id>
  </id_info>
  <brief_title>Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery</brief_title>
  <official_title>The Role of Regional Anesthesia to Reduce Opioid Requirements Following Functional Endoscopic Sinus Surgery (FESS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</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>
      Opioids are prescribed for moderate to severe pain disorders; however, there are&#xD;
      contraindications and side effects that are common to all opioids. The investigators&#xD;
      hypothesize using regional anesthetic during sinus surgery will reduce surgical pain,&#xD;
      therefore decreasing the need for post-operative opioid medication. The primary of objective&#xD;
      is to determine if a long-acting local regional anesthetic applied during a surgery will&#xD;
      reduce post-operative oral opioid usage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Opioid analgesics are prescribed for moderate to severe acute pain; however, there are&#xD;
      contraindications, cautions, and side effects that are common with all opioids. Dependence&#xD;
      and tolerance are also likely with regular opioid use, resulting in the current nationwide&#xD;
      opioid epidemic. In Alabama alone, there were 343 opioid-related overdose deaths in 2016, 124&#xD;
      of which were related to prescription opioids. Alabama providers have the highest prescribing&#xD;
      rate in the country, nearly twice the national rate, per the NIH/NIDA website. In 2015, the&#xD;
      Centers for Disease Control (CDC) released prescribing guidelines relating to chronic pain,&#xD;
      and in 2018 Alabama's Blue Cross/Blue Shield insurance group limited the supply of opioids&#xD;
      allowed to their members to 7 days.&#xD;
&#xD;
      There is currently no clinical guideline for prescribing post operative opioid medications&#xD;
      for functional endoscopic sinus surgery (FESS). A 2018 survey documenting prescribing&#xD;
      patterns by 168 members of the American Rhinologic Society found that most physicians who&#xD;
      participated prescribed, on average, 27 opioid pain pills for patients after surgery. Prior&#xD;
      studies have been performed to help decrease the pain patient's feel after sinus surgery.&#xD;
      Haytoglu in 2016 revealed that adding non-absorbable sinus packs loaded with local&#xD;
      anesthetics such as bupivacaine achieved less pain values and improved patient satisfaction&#xD;
      scores.&#xD;
&#xD;
      Given this current data the investigators believe injecting patients with a long acting&#xD;
      analgesic during the procedure will help reduce post-operative pain. If the investigators can&#xD;
      decrease the amount of pain patients have in the post-operative period, they can&#xD;
      theoretically decrease the number of opioid pain pills prescribed. The investigators plan to&#xD;
      also track the number of opioid pills consumed by patients in the post-operative period to&#xD;
      obtain a somewhat uniform prescribing pattern within surgeons.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2019</start_date>
  <completion_date type="Actual">April 12, 2021</completion_date>
  <primary_completion_date type="Actual">March 12, 2021</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participant Pain Control</measure>
    <time_frame>10 days</time_frame>
    <description>Self-report of pain score on a scale of 0 to 10, with 0 being &quot;no pain&quot; and 10 being &quot;worst pain imaginable&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid Medication Use</measure>
    <time_frame>10 days</time_frame>
    <description>Amount of opioid medication used, based on pill count</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Pain Management</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 mL of 1.3% bupivacaine with 2 mg dexamethasone injected locally in the location for sensory nerves of the sinus cavities and face during the functional endoscopic sinus surgery (FESS) procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No regional anesthetic of any kind during the functional endoscopic sinus surgery (FESS) procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>20 mL of 1.3% bupivacaine</description>
    <arm_group_label>Treatment Group</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>2 mg dexamethasone</description>
    <arm_group_label>Treatment Group</arm_group_label>
    <other_name>Ozurdex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Able to sign informed consent form&#xD;
&#xD;
          -  Able to comply with all study procedures and availability for the duration of the&#xD;
             study&#xD;
&#xD;
          -  Able to speak English&#xD;
&#xD;
          -  Diagnosis of chronic rhinosinusitis&#xD;
&#xD;
          -  Scheduled to receive functional endoscopic sinus surgery (FESS) at UAB&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current use of opioid medication&#xD;
&#xD;
          -  Known allergic reactions to components of the study intervention&#xD;
&#xD;
          -  History of IV drug use or abuse&#xD;
&#xD;
          -  History of opioid abuse&#xD;
&#xD;
          -  History of chronic pain disorder&#xD;
&#xD;
          -  Treatment with another investigational drug or other intervention within 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brad Woodworth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <results_first_submitted>March 20, 2022</results_first_submitted>
  <results_first_submitted_qc>August 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 31, 2022</results_first_posted>
  <last_update_submitted>August 12, 2022</last_update_submitted>
  <last_update_submitted_qc>August 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Brad Woodworth, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 16, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03757715/Prot_ICF_004.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>No patients were excluded prior to assignment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment Group</title>
          <description>20 mL of 1.3% bupivacaine with 2 mg dexamethasone injected locally in the location for sensory nerves of the sinus cavities and face during the functional endoscopic sinus surgery (FESS) procedure&#xD;
Bupivacaine: 20 mL of 1.3% bupivacaine&#xD;
Dexamethasone: 2 mg dexamethasone</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>No regional anesthetic of any kind during the functional endoscopic sinus surgery (FESS) procedure</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment Group</title>
          <description>20 mL of 1.3% bupivacaine with 2 mg dexamethasone injected locally in the location for sensory nerves of the sinus cavities and face during the functional endoscopic sinus surgery (FESS) procedure&#xD;
Bupivacaine: 20 mL of 1.3% bupivacaine&#xD;
Dexamethasone: 2 mg dexamethasone</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>No regional anesthetic of any kind during the functional endoscopic sinus surgery (FESS) procedure</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="31"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.69" spread="17.79"/>
                    <measurement group_id="B2" value="36.73" spread="13.10"/>
                    <measurement group_id="B3" value="42.90" spread="13.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.19" spread="7.66"/>
                    <measurement group_id="B2" value="31.71" spread="11.10"/>
                    <measurement group_id="B3" value="31.44" spread="9.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Anxiety/Depression</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Migraine</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Obstructive Sleep Apnea</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Participant Pain Control</title>
        <description>Self-report of pain score on a scale of 0 to 10, with 0 being &quot;no pain&quot; and 10 being &quot;worst pain imaginable&quot;</description>
        <time_frame>10 days</time_frame>
        <population>Both groups were analyzed on the average number of pain pills taken during the post-operative time and average pain scores per day postoperatively</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>20 mL of 1.3% bupivacaine with 2 mg dexamethasone injected locally in the location for sensory nerves of the sinus cavities and face during the functional endoscopic sinus surgery (FESS) procedure&#xD;
Bupivacaine: 20 mL of 1.3% bupivacaine&#xD;
Dexamethasone: 2 mg dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>No regional anesthetic of any kind during the functional endoscopic sinus surgery (FESS) procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Pain Control</title>
          <description>Self-report of pain score on a scale of 0 to 10, with 0 being &quot;no pain&quot; and 10 being &quot;worst pain imaginable&quot;</description>
          <population>Both groups were analyzed on the average number of pain pills taken during the post-operative time and average pain scores per day postoperatively</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POD 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="2.83"/>
                    <measurement group_id="O2" value="5.87" spread="2.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.63" spread="1.86"/>
                    <measurement group_id="O2" value="5.00" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.06" spread="1.84"/>
                    <measurement group_id="O2" value="4.13" spread="1.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.13" spread="1.46"/>
                    <measurement group_id="O2" value="3.20" spread="2.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.38" spread="1.93"/>
                    <measurement group_id="O2" value="2.67" spread="2.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" spread="2.42"/>
                    <measurement group_id="O2" value="2.33" spread="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" spread="2.58"/>
                    <measurement group_id="O2" value="2.2" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.56" spread="2.45"/>
                    <measurement group_id="O2" value="2.13" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.13" spread="2.45"/>
                    <measurement group_id="O2" value="1.67" spread="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.19" spread="2.34"/>
                    <measurement group_id="O2" value="1.73" spread="2.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.13" spread="2.50"/>
                    <measurement group_id="O2" value="1.27" spread="2.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.16</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Opioid Medication Use</title>
        <description>Amount of opioid medication used, based on pill count</description>
        <time_frame>10 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>20 mL of 1.3% bupivacaine with 2 mg dexamethasone injected locally in the location for sensory nerves of the sinus cavities and face during the functional endoscopic sinus surgery (FESS) procedure&#xD;
Bupivacaine: 20 mL of 1.3% bupivacaine&#xD;
Dexamethasone: 2 mg dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>No regional anesthetic of any kind during the functional endoscopic sinus surgery (FESS) procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Medication Use</title>
          <description>Amount of opioid medication used, based on pill count</description>
          <units>pills consumed</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POD 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.38" spread="1.03"/>
                    <measurement group_id="O2" value="1.07" spread="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.31" spread="1.40"/>
                    <measurement group_id="O2" value="1.87" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.69" spread="1.66"/>
                    <measurement group_id="O2" value="1.40" spread="1.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.63" spread="1.45"/>
                    <measurement group_id="O2" value="1.07" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="1.49"/>
                    <measurement group_id="O2" value="1.00" spread="1.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.594" spread="1.11"/>
                    <measurement group_id="O2" value="0.567" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" spread="1.09"/>
                    <measurement group_id="O2" value="0.30" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="0.885"/>
                    <measurement group_id="O2" value="0.27" spread="0.799"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="0.577"/>
                    <measurement group_id="O2" value="0.20" spread="0.775"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" spread="0.60"/>
                    <measurement group_id="O2" value="0.27" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" spread="0.60"/>
                    <measurement group_id="O2" value="0.27" spread="0.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.42</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 weeks</time_frame>
      <desc>death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment Group</title>
          <description>20 mL of 1.3% bupivacaine with 2 mg dexamethasone injected locally in the location for sensory nerves of the sinus cavities and face during the functional endoscopic sinus surgery (FESS) procedure&#xD;
Bupivacaine: 20 mL of 1.3% bupivacaine&#xD;
Dexamethasone: 2 mg dexamethasone</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>No regional anesthetic of any kind during the functional endoscopic sinus surgery (FESS) procedure</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Jessica W. Grayson</name_or_title>
      <organization>UAB</organization>
      <phone>205-801-7801</phone>
      <email>jgrayson@uabmc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03757715
org study id: IRB-300000567
nct id: NCT03757715
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Opioids are prescribed for moderate to severe pain disorders; however, there are
      contraindications and side effects that are common to all opioids. The investigators
      hypothesize using regional anesthetic during sinus surgery will reduce surgical pain,
      therefore decreasing the need for post-operative opioid medication. The primary of objective
      is to determine if a long-acting local regional anesthetic applied during a surgery will
      reduce post-operative oral opioid usage.
Opioid analgesics are prescribed for moderate to severe acute pain; however, there are
      contraindications, cautions, and side effects that are common with all opioids. Dependence
      and tolerance are also likely with regular opioid use, resulting in the current nationwide
      opioid epidemic. In Alabama alone, there were 343 opioid-related overdose deaths in 2016, 124
      of which were related to prescription opioids. Alabama providers have the highest prescribing
      rate in the country, nearly twice the national rate, per the NIH/NIDA website. In 2015, the
      Centers for Disease Control (CDC) released prescribing guidelines relating to chronic pain,
      and in 2018 Alabama's Blue Cross/Blue Shield insurance group limited the supply of opioids
      allowed to their members to 7 days.

      There is currently no clinical guideline for prescribing post operative opioid medications
      for functional endoscopic sinus surgery (FESS). A 2018 survey documenting prescribing
      patterns by 168 members of the American Rhinologic Society found that most physicians who
      participated prescribed, on average, 27 opioid pain pills for patients after surgery. Prior
      studies have been performed to help decrease the pain patient's feel after sinus surgery.
      Haytoglu in 2016 revealed that adding non-absorbable sinus packs loaded with local
      anesthetics such as bupivacaine achieved less pain values and improved patient satisfaction
      scores.

      Given this current data the investigators believe injecting patients with a long acting
      analgesic during the procedure will help reduce post-operative pain. If the investigators can
      decrease the amount of pain patients have in the post-operative period, they can
      theoretically decrease the number of opioid pain pills prescribed. The investigators plan to
      also track the number of opioid pills consumed by patients in the post-operative period to
      obtain a somewhat uniform prescribing pattern within surgeons.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Participant Pain Control
time frame: 10 days
description: Self-report of pain score on a scale of 0 to 10, with 0 being "no pain" and 10 being "worst pain imaginable"
measure: Opioid Medication Use
time frame: 10 days
description: Amount of opioid medication used, based on pill count
arm group label: Treatment Group
arm group type: Experimental
description: 20 mL of 1.3% bupivacaine with 2 mg dexamethasone injected locally in the location for sensory nerves of the sinus cavities and face during the functional endoscopic sinus surgery (FESS) procedure
arm group label: Control Group
arm group type: No Intervention
description: No regional anesthetic of any kind during the functional endoscopic sinus surgery (FESS) procedure
intervention type: Drug
intervention name: Bupivacaine
description: 20 mL of 1.3% bupivacaine
arm group label: Treatment Group
other name: Marcaine
intervention type: Drug
intervention name: Dexamethasone
description: 2 mg dexamethasone
arm group label: Treatment Group
other name: Ozurdex
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brad Woodworth, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Brad Woodworth, MD
investigator title: Principal Investigator
mesh term: Dexamethasone
mesh term: Bupivacaine
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 