<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/NCT02205801</url>
  </required_header>
  <id_info>
    <org_study_id>IRB14-0374</org_study_id>
    <nct_id>NCT02205801</nct_id>
  </id_info>
  <brief_title>Study of the Efficacy of Local Analgesia as an Adjunct to General Anesthesia in Thyroidectomy and Parathyroidectomy</brief_title>
  <official_title>A Randomized Control Trial Comparing Bilateral Superficial Cervical Plexus Block and Local Wound Infiltration in Thyroidectomy and Parathyroidectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We aim to study the effect of local anesthetic when used in conjunction with general&#xD;
      anesthesia during thyroidectomy or parathyroidectomy. We hypothesize there is equivalent pain&#xD;
      control between bilateral superficial cervical plexus block and local wound infiltration when&#xD;
      used in conjunction with a general anesthetic.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">February 17, 2017</completion_date>
  <primary_completion_date type="Actual">February 10, 2017</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraoperative Fentanyl Administration</measure>
    <time_frame>During the procedure</time_frame>
    <description>The total amount of Fentanyl administered during the procedure will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post Operative Pain</measure>
    <time_frame>At four hour after operation</time_frame>
    <description>Pain scores will either be verbally reported to nursing and recorded or reported on a questionnaire. Back of neck pain scores range 0-10, throat pain scores range 0-9, incisional pain scores range 0-9 (zero means no pain and 9 or 10 means severe pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post Operative Nausea Score</measure>
    <time_frame>At 2 weeks after operation</time_frame>
    <description>Nausea scores will either be verbally reported to nursing and recorded or reported on a questionnaire. The scores range 0-9 (zero means no symptom and 9 means &quot;very severe&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Pain Medication Utilization</measure>
    <time_frame>At follow up appointment 1-2 weeks postoperatively</time_frame>
    <description>Total operative opioid dosages administered converted to effective mg of Hydromorphine.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Thyroid Neoplasms</condition>
  <condition>Goiter, Nodular</condition>
  <condition>Thyroid Nodule</condition>
  <condition>Graves' Disease</condition>
  <condition>Hyperparathyroidism</condition>
  <arm_group>
    <arm_group_label>superficial cervical block, active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>local wound infiltration, placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>local wound infiltration, active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>superficial cervical block, placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Superficial Cervical Plexus Block</intervention_name>
    <description>0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.</description>
    <arm_group_label>superficial cervical block, active</arm_group_label>
    <arm_group_label>superficial cervical block, placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Local Wound Infiltration</intervention_name>
    <description>0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.</description>
    <arm_group_label>local wound infiltration, active</arm_group_label>
    <arm_group_label>local wound infiltration, placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9% saline</intervention_name>
    <arm_group_label>local wound infiltration, placebo</arm_group_label>
    <arm_group_label>superficial cervical block, placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Marcaine</intervention_name>
    <arm_group_label>local wound infiltration, active</arm_group_label>
    <arm_group_label>superficial cervical block, active</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient ≥ 18 years old&#xD;
&#xD;
          -  Surgical indication for parathyroidectomy or thyroidectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt; 18 years old&#xD;
&#xD;
          -  Patient with history of chronic opioid use&#xD;
&#xD;
          -  Patient with chronic pain syndromes&#xD;
&#xD;
          -  Patient with allergy to marcaine&#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>Raymon Grogan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <results_first_submitted>January 12, 2018</results_first_submitted>
  <results_first_submitted_qc>January 12, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 7, 2018</results_first_posted>
  <last_update_submitted>February 8, 2018</last_update_submitted>
  <last_update_submitted_qc>February 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Nodule</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Graves Disease</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
    <mesh_term>Hyperparathyroidism</mesh_term>
    <mesh_term>Goiter, Nodular</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 8, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT02205801/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Superficial Cervical Block, Active</title>
          <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.&#xD;
Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
Marcaine</description>
        </group>
        <group group_id="P2">
          <title>Superficial Cervical Block, Placebo</title>
          <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.&#xD;
Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
0.9% saline</description>
        </group>
        <group group_id="P3">
          <title>Local Wound Infiltration, Active</title>
          <description>After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.&#xD;
Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
Marcaine</description>
        </group>
        <group group_id="P4">
          <title>Local Wound Infiltration, Placebo</title>
          <description>After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.&#xD;
Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
0.9% saline</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Superficial Cervical Block, Active</title>
          <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.&#xD;
Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
Marcaine</description>
        </group>
        <group group_id="B2">
          <title>Superficial Cervical Block, Placebo</title>
          <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.&#xD;
Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
0.9% saline</description>
        </group>
        <group group_id="B3">
          <title>Local Wound Infiltration, Active</title>
          <description>After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.&#xD;
Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
Marcaine</description>
        </group>
        <group group_id="B4">
          <title>Local Wound Infiltration, Placebo</title>
          <description>After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.&#xD;
Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
0.9% saline</description>
        </group>
        <group group_id="B5">
          <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="11"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="9"/>
            <count group_id="B4" value="8"/>
            <count group_id="B5" value="36"/>
          </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="52" spread="13.1"/>
                    <measurement group_id="B2" value="47.4" spread="15.5"/>
                    <measurement group_id="B3" value="48.2" spread="9.5"/>
                    <measurement group_id="B4" value="51.6" spread="15.3"/>
                    <measurement group_id="B5" value="49.4" spread="13"/>
                  </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="8"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="9"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" 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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="25"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" 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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Intraoperative Fentanyl Administration</title>
        <description>The total amount of Fentanyl administered during the procedure will be recorded.</description>
        <time_frame>During the procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Superficial Cervical Block, Active</title>
            <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.&#xD;
Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
Marcaine</description>
          </group>
          <group group_id="O2">
            <title>Superficial Cervical Block, Placebo</title>
            <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.&#xD;
Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
0.9% saline</description>
          </group>
          <group group_id="O3">
            <title>Local Wound Infiltration, Active</title>
            <description>After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.&#xD;
Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
Marcaine</description>
          </group>
          <group group_id="O4">
            <title>Local Wound Infiltration, Placebo</title>
            <description>After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.&#xD;
Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
0.9% saline</description>
          </group>
        </group_list>
        <measure>
          <title>Intraoperative Fentanyl Administration</title>
          <description>The total amount of Fentanyl administered during the procedure will be recorded.</description>
          <units>mcg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="187.5" spread="89.2"/>
                    <measurement group_id="O2" value="185.7" spread="80.2"/>
                    <measurement group_id="O3" value="144.2" spread="65.0"/>
                    <measurement group_id="O4" value="156.3" spread="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post Operative Pain</title>
        <description>Pain scores will either be verbally reported to nursing and recorded or reported on a questionnaire. Back of neck pain scores range 0-10, throat pain scores range 0-9, incisional pain scores range 0-9 (zero means no pain and 9 or 10 means severe pain).</description>
        <time_frame>At four hour after operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Superficial Cervical Block, Active</title>
            <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.&#xD;
Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
Marcaine</description>
          </group>
          <group group_id="O2">
            <title>Superficial Cervical Block, Placebo</title>
            <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.&#xD;
Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
0.9% saline</description>
          </group>
          <group group_id="O3">
            <title>Local Wound Infiltration, Active</title>
            <description>After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.&#xD;
Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
Marcaine</description>
          </group>
          <group group_id="O4">
            <title>Local Wound Infiltration, Placebo</title>
            <description>After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.&#xD;
Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
0.9% saline</description>
          </group>
        </group_list>
        <measure>
          <title>Post Operative Pain</title>
          <description>Pain scores will either be verbally reported to nursing and recorded or reported on a questionnaire. Back of neck pain scores range 0-10, throat pain scores range 0-9, incisional pain scores range 0-9 (zero means no pain and 9 or 10 means severe pain).</description>
          <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="11"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Incision</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="2.6"/>
                    <measurement group_id="O2" value="2.8" spread="1.6"/>
                    <measurement group_id="O3" value="4.4" spread="2.9"/>
                    <measurement group_id="O4" value="2.9" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Back of neck</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.3"/>
                    <measurement group_id="O2" value="3.4" spread="3.4"/>
                    <measurement group_id="O3" value="2.3" spread="2.1"/>
                    <measurement group_id="O4" value="2.4" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Throat</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="1.6"/>
                    <measurement group_id="O2" value="5.3" spread="2.3"/>
                    <measurement group_id="O3" value="6.4" spread="1.9"/>
                    <measurement group_id="O4" value="3.9" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post Operative Nausea Score</title>
        <description>Nausea scores will either be verbally reported to nursing and recorded or reported on a questionnaire. The scores range 0-9 (zero means no symptom and 9 means &quot;very severe&quot;).</description>
        <time_frame>At 2 weeks after operation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Superficial Cervical Block, Active</title>
            <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.&#xD;
Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
Marcaine</description>
          </group>
          <group group_id="O2">
            <title>Superficial Cervical Block, Placebo</title>
            <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.&#xD;
Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
0.9% saline</description>
          </group>
          <group group_id="O3">
            <title>Local Wound Infiltration, Active</title>
            <description>After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.&#xD;
Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
Marcaine</description>
          </group>
          <group group_id="O4">
            <title>Local Wound Infiltration, Placebo</title>
            <description>After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.&#xD;
Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
0.9% saline</description>
          </group>
        </group_list>
        <measure>
          <title>Post Operative Nausea Score</title>
          <description>Nausea scores will either be verbally reported to nursing and recorded or reported on a questionnaire. The scores range 0-9 (zero means no symptom and 9 means &quot;very severe&quot;).</description>
          <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="11"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Incision</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="0.5"/>
                    <measurement group_id="O2" value="1.0" spread="0"/>
                    <measurement group_id="O3" value="1.4" spread="1.1"/>
                    <measurement group_id="O4" value="1.4" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Back of neck</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.0"/>
                    <measurement group_id="O2" value="1.2" spread="0.4"/>
                    <measurement group_id="O3" value="1.3" spread="0.5"/>
                    <measurement group_id="O4" value="1.0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Throat</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="0.8"/>
                    <measurement group_id="O2" value="1.0" spread="0"/>
                    <measurement group_id="O3" value="2.0" spread="1.5"/>
                    <measurement group_id="O4" value="1.2" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Pain Medication Utilization</title>
        <description>Total operative opioid dosages administered converted to effective mg of Hydromorphine.</description>
        <time_frame>At follow up appointment 1-2 weeks postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Superficial Cervical Block, Active</title>
            <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.&#xD;
Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
Marcaine</description>
          </group>
          <group group_id="O2">
            <title>Superficial Cervical Block, Placebo</title>
            <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.&#xD;
Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
0.9% saline</description>
          </group>
          <group group_id="O3">
            <title>Local Wound Infiltration, Active</title>
            <description>After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.&#xD;
Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
Marcaine</description>
          </group>
          <group group_id="O4">
            <title>Local Wound Infiltration, Placebo</title>
            <description>After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.&#xD;
Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
0.9% saline</description>
          </group>
        </group_list>
        <measure>
          <title>Total Pain Medication Utilization</title>
          <description>Total operative opioid dosages administered converted to effective mg of Hydromorphine.</description>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" spread="0.43"/>
                    <measurement group_id="O2" value="0.71" spread="0.4"/>
                    <measurement group_id="O3" value="0.84" spread="0.47"/>
                    <measurement group_id="O4" value="0.79" spread="0.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Superficial Cervical Block, Active</title>
          <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.&#xD;
Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
Marcaine</description>
        </group>
        <group group_id="E2">
          <title>Superficial Cervical Block, Placebo</title>
          <description>After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.&#xD;
Superficial Cervical Plexus Block: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
0.9% saline</description>
        </group>
        <group group_id="E3">
          <title>Local Wound Infiltration, Active</title>
          <description>After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.&#xD;
Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
Marcaine</description>
        </group>
        <group group_id="E4">
          <title>Local Wound Infiltration, Placebo</title>
          <description>After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.&#xD;
Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.&#xD;
0.9% saline</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="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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. Raymond H. Grogan</name_or_title>
      <organization>The University of Chicago Medicine &amp; Biological Sciences</organization>
      <phone>773-702-7125</phone>
      <email>rgrogan@surgery.bsd.uchicago.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/NCT02205801
org study id: IRB14-0374
nct id: NCT02205801
lead sponsor: 
has dmc: Yes
We aim to study the effect of local anesthetic when used in conjunction with general
      anesthesia during thyroidectomy or parathyroidectomy. We hypothesize there is equivalent pain
      control between bilateral superficial cervical plexus block and local wound infiltration when
      used in conjunction with a general anesthetic.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Intraoperative Fentanyl Administration
time frame: During the procedure
description: The total amount of Fentanyl administered during the procedure will be recorded.
measure: Post Operative Pain
time frame: At four hour after operation
description: Pain scores will either be verbally reported to nursing and recorded or reported on a questionnaire. Back of neck pain scores range 0-10, throat pain scores range 0-9, incisional pain scores range 0-9 (zero means no pain and 9 or 10 means severe pain).
measure: Post Operative Nausea Score
time frame: At 2 weeks after operation
description: Nausea scores will either be verbally reported to nursing and recorded or reported on a questionnaire. The scores range 0-9 (zero means no symptom and 9 means "very severe").
measure: Total Pain Medication Utilization
time frame: At follow up appointment 1-2 weeks postoperatively
description: Total operative opioid dosages administered converted to effective mg of Hydromorphine.
arm group label: superficial cervical block, active
arm group type: Active Comparator
description: After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.
arm group label: local wound infiltration, placebo
arm group type: Placebo Comparator
description: After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.
arm group label: local wound infiltration, active
arm group type: Active Comparator
description: After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.
arm group label: superficial cervical block, placebo
arm group type: Placebo Comparator
description: After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.
intervention type: Procedure
intervention name: Superficial Cervical Plexus Block
description: 0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.
arm group label: superficial cervical block, active
arm group label: superficial cervical block, placebo
intervention type: Procedure
intervention name: Local Wound Infiltration
description: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.
arm group label: local wound infiltration, active
arm group label: local wound infiltration, placebo
intervention type: Drug
intervention name: 0.9% saline
arm group label: local wound infiltration, placebo
arm group label: superficial cervical block, placebo
intervention type: Drug
intervention name: Marcaine
arm group label: local wound infiltration, active
arm group label: superficial cervical block, active
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raymon Grogan, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Thyroid Nodule
mesh term: Thyroid Neoplasms
mesh term: Graves Disease
mesh term: Thyroid Diseases
mesh term: Hyperparathyroidism
mesh term: Goiter, Nodular
mesh term: Bupivacaine
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 