<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/NCT04427904</url>
  </required_header>
  <id_info>
    <org_study_id>7336</org_study_id>
    <nct_id>NCT04427904</nct_id>
  </id_info>
  <brief_title>Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery</brief_title>
  <official_title>Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Joseph's Healthcare Hamilton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Joseph's Healthcare Hamilton</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the efficacy of Bupivicaine and Lidocaine for&#xD;
      postoperative pain control in thyroid surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients planned for total thyroidectomy will be recruited for participation. After being&#xD;
      informed about the study and potential risks, all patients giving written informed consent&#xD;
      will be screened for eligibility for study entry. Patients that meet inclusion and exclusion&#xD;
      criteria will be randomized via block randomization in a double blind fashion and a 1:1 ratio&#xD;
      to surgical incision infiltration with Bupivacaine (0.5% with 1:200 000 epinephrine) or&#xD;
      Lidocaine (2% with 1:100 000 epinephrine).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2022</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>30 minutes after surgery</time_frame>
    <description>Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>1 hour after surgery</time_frame>
    <description>Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>2 hours after surgery</time_frame>
    <description>Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>3 hours after surgery</time_frame>
    <description>Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>4 hours after surgery</time_frame>
    <description>Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>8 hours after surgery</time_frame>
    <description>Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>12 hours after surgery</time_frame>
    <description>Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>First dose of additional postoperative analgesia</measure>
    <time_frame>Up to 72 hours after surgery</time_frame>
    <description>Time since completion of surgery when additional postoperative analgesia outside of standardized protocol was administered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inpatient analgesia utilization</measure>
    <time_frame>Up to 72 hours after surgery</time_frame>
    <description>Quantity of standardized analgesia used during admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outpatient analgesia utilization</measure>
    <time_frame>Up to 4 weeks after surgery</time_frame>
    <description>Quantity of standardized analgesia used between discharge and 4 week outpatient follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to return of sensation</measure>
    <time_frame>Up to 4 weeks after surgery</time_frame>
    <description>Patient reported time to return of sensation at surgical site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of postoperative complications</measure>
    <time_frame>4 weeks</time_frame>
    <description>Incidence of complications including bleeding, hematoma, surgical site infection, dehiscence, re-exploration, persistent paresthesia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of local anesthesia related adverse events</measure>
    <time_frame>4 weeks</time_frame>
    <description>Incidence of adverse events including CNS (tinnitus, blurred vision, dizziness, tongue paresthesias, circumoral numbness, seizures, CNS depression) and cardiovascular (hear block, sinus bradycardia, sinus arrest, ventricular arrhythmias) events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>1 week</time_frame>
    <description>Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>2 week</time_frame>
    <description>Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>4 week</time_frame>
    <description>Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">210</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Thyroid Diseases</condition>
  <condition>Anesthesia, Local</condition>
  <arm_group>
    <arm_group_label>Bupivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine 0.5% with 1:200 000 epinephrine</intervention_name>
    <description>Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.</description>
    <arm_group_label>Bupivacaine</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine 2% with 1:100 000 epinephrine</intervention_name>
    <description>Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.</description>
    <arm_group_label>Lidocaine</arm_group_label>
    <other_name>Xylocaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of thyroid disease (malignant tumors T1-T3/NX-N1a, benign tumors)&#xD;
&#xD;
          -  Planned for thyroid surgery with midline neck incision (total thyroidectomy,&#xD;
             completion thyroidectomy, with or without central neck dissection)&#xD;
&#xD;
          -  Will be admitted for at least 12h postoperatively&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Thyroid cancer staged as T4 (invasion, anaplastic) or requiring sternotomy&#xD;
&#xD;
          -  Thyroid cancer staged as N1b (cervical, retropharyngeal, superior mediastinal nodal&#xD;
             involvement)&#xD;
&#xD;
          -  Previous ipsilateral thyroid surgery to operation side&#xD;
&#xD;
          -  Previous total thyroidectomy or completion thyroidectomy&#xD;
&#xD;
          -  History of neck radiation therapy&#xD;
&#xD;
          -  Neck dissection beyond central neck (levels 1-5)&#xD;
&#xD;
          -  Goiter extending beyond sternal notch (intrathoracic) or requiring sternotomy&#xD;
&#xD;
          -  Surgery requiring extension of incision beyond 8 cm&#xD;
&#xD;
          -  History of diabetes mellitus&#xD;
&#xD;
          -  History of renal or liver disease&#xD;
&#xD;
          -  History of narcotic abuse&#xD;
&#xD;
          -  History of chronic pain medications use in past 6 months for any condition&#xD;
&#xD;
          -  History of coagulation defect&#xD;
&#xD;
          -  Allergy to Bupivacaine or Lidocaine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Han Zhang, MD FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Joseph's Hospital Hamilton</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Xie, MD</last_name>
    <phone>(905) 522-1155</phone>
    <phone_ext>4765</phone_ext>
    <email>michael.xie@medportal.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Han Zhang, MD FRCSC</last_name>
    <phone>(905) 521-2100</phone>
    <phone_ext>37031</phone_ext>
    <email>hanzhang@stjosham.on.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St. Joeseph's Healthcare Hamilton</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N4A6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Xie, MD</last_name>
      <phone>(905) 522-1155</phone>
      <phone_ext>4765</phone_ext>
      <email>michael.xie@medportal.ca</email>
    </contact>
    <contact_backup>
      <last_name>Han Zhang, MD FRCSC</last_name>
      <phone>(905) 521-2100</phone>
      <phone_ext>37031</phone_ext>
      <email>hanzhang@stjosham.on.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>October 29, 2022</last_update_submitted>
  <last_update_submitted_qc>October 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Joseph's Healthcare Hamilton</investigator_affiliation>
    <investigator_full_name>Michael Xie</investigator_full_name>
    <investigator_title>Resident Physician</investigator_title>
  </responsible_party>
  <keyword>Thyroidectomy</keyword>
  <keyword>Bupivacaine</keyword>
  <keyword>Lidocaine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Diseases</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Racepinephrine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Epinephryl borate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04427904
org study id: 7336
nct id: NCT04427904
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the efficacy of Bupivicaine and Lidocaine for
      postoperative pain control in thyroid surgery.
Patients planned for total thyroidectomy will be recruited for participation. After being
      informed about the study and potential risks, all patients giving written informed consent
      will be screened for eligibility for study entry. Patients that meet inclusion and exclusion
      criteria will be randomized via block randomization in a double blind fashion and a 1:1 ratio
      to surgical incision infiltration with Bupivacaine (0.5% with 1:200 000 epinephrine) or
      Lidocaine (2% with 1:100 000 epinephrine).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Postoperative Pain
time frame: 30 minutes after surgery
description: Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
measure: Postoperative Pain
time frame: 1 hour after surgery
description: Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
measure: Postoperative Pain
time frame: 2 hours after surgery
description: Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
measure: Postoperative Pain
time frame: 3 hours after surgery
description: Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
measure: Postoperative Pain
time frame: 4 hours after surgery
description: Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
measure: Postoperative Pain
time frame: 8 hours after surgery
description: Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
measure: Postoperative Pain
time frame: 12 hours after surgery
description: Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
measure: First dose of additional postoperative analgesia
time frame: Up to 72 hours after surgery
description: Time since completion of surgery when additional postoperative analgesia outside of standardized protocol was administered
measure: Inpatient analgesia utilization
time frame: Up to 72 hours after surgery
description: Quantity of standardized analgesia used during admission
measure: Outpatient analgesia utilization
time frame: Up to 4 weeks after surgery
description: Quantity of standardized analgesia used between discharge and 4 week outpatient follow up
measure: Time to return of sensation
time frame: Up to 4 weeks after surgery
description: Patient reported time to return of sensation at surgical site
measure: Incidence of postoperative complications
time frame: 4 weeks
description: Incidence of complications including bleeding, hematoma, surgical site infection, dehiscence, re-exploration, persistent paresthesia
measure: Incidence of local anesthesia related adverse events
time frame: 4 weeks
description: Incidence of adverse events including CNS (tinnitus, blurred vision, dizziness, tongue paresthesias, circumoral numbness, seizures, CNS depression) and cardiovascular (hear block, sinus bradycardia, sinus arrest, ventricular arrhythmias) events.
measure: Postoperative pain
time frame: 1 week
description: Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
measure: Postoperative pain
time frame: 2 week
description: Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
measure: Postoperative pain
time frame: 4 week
description: Patient reported postoperative pain reported on a 10cm pain visual analogue scale (VAS), minimum value of 0cm (no pain) and maximum value of 10cm (worst pain possible), lower VAS measurement represents better outcome
arm group label: Bupivacaine
arm group type: Experimental
description: Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.
arm group label: Lidocaine
arm group type: Active Comparator
description: Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.
intervention type: Drug
intervention name: Bupivacaine 0.5% with 1:200 000 epinephrine
description: Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.
arm group label: Bupivacaine
other name: Marcaine
intervention type: Drug
intervention name: Lidocaine 2% with 1:100 000 epinephrine
description: Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.
arm group label: Lidocaine
other name: Xylocaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Han Zhang, MD FRCSC
role: Principal Investigator
affiliation: St. Joseph's Hospital Hamilton
last name: Michael Xie, MD
phone: (905) 522-1155
phone ext: 4765
email: michael.xie@medportal.ca
last name: Han Zhang, MD FRCSC
phone: (905) 521-2100
phone ext: 37031
email: hanzhang@stjosham.on.ca
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Joseph's Healthcare Hamilton
investigator full name: Michael Xie
investigator title: Resident Physician
mesh term: Thyroid Diseases
mesh term: Pain, Postoperative
mesh term: Lidocaine
mesh term: Epinephrine
mesh term: Racepinephrine
mesh term: Bupivacaine
mesh term: Epinephryl borate
sharing ipd: No