<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/NCT02981095</url>
  </required_header>
  <id_info>
    <org_study_id>IUCTF-EndSx-2010-01</org_study_id>
    <nct_id>NCT02981095</nct_id>
  </id_info>
  <brief_title>Effect of Bupivacaine Application on Postthyroidectomy Pain</brief_title>
  <official_title>Bupivacaine Application Reduces Postthyroidectomy Pain: Cerrahpaşa Experience</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators aimed to evaluate the impact of bupivacaine administration into the surgical&#xD;
      field after total thyroidectomy on post-operative pain and analgesic requirement with a&#xD;
      double-blind, prospective, clinical, randomized study.&#xD;
&#xD;
      Pain assessment was performed with the visual analog score (VAS). Participants were&#xD;
      pre-operatively, divided into two groups randomly to receive either bupivacaine or not. One&#xD;
      group received a 10 ml of bupivacaine solution while the other group was treated with the&#xD;
      same volume of 0.9% sodium chloride (NaCl) through the drain after completion of total&#xD;
      thyroidectomy procedure. All participants were anesthetized and operated with the same&#xD;
      anesthesia and surgical team.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">March 2011</completion_date>
  <primary_completion_date type="Actual">January 2011</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative pain in 8 hours after surgery using VAS</measure>
    <time_frame>8th hour</time_frame>
    <description>Evaluation of the pain through the post-operative first 8 hours using VAS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative pain in in first post-operative day using VAS</measure>
    <time_frame>1 day</time_frame>
    <description>Evaluation of the pain through the first post-operative day using VAS</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Thyroid Disease</condition>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>Bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline solution (%0.9 sodium chloride), 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thyroidectomy</intervention_name>
    <description>Thyroidectomy performed by the same surgical and anesthesia team</description>
    <arm_group_label>Bupivacaine</arm_group_label>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.</description>
    <arm_group_label>Bupivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline Solution</intervention_name>
    <description>%0.9 sodium chloride solution, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.</description>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects need to be operated for thyroid diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of previous thyroid disease,&#xD;
&#xD;
          -  History of previous neck operations,&#xD;
&#xD;
          -  Hypersensitivity to the drugs that were used in the study protocol,&#xD;
&#xD;
          -  Spinal bone disease,&#xD;
&#xD;
          -  Depression,&#xD;
&#xD;
          -  Kidney failure,&#xD;
&#xD;
          -  Heart failure,&#xD;
&#xD;
          -  Liver failure,&#xD;
&#xD;
          -  Pulmonary failure,&#xD;
&#xD;
          -  Mental retardation,&#xD;
&#xD;
          -  Subjects not able to ascertain pain scoring with the visual analog score (VAS),&#xD;
&#xD;
          -  Patients with American Society of Anesthesiologists (ASA) scores III or higher,&#xD;
&#xD;
          -  Expected airway difficulty according to Mallampati scores,&#xD;
&#xD;
          -  Sedative, steroid, and chronic analgesic drug users,&#xD;
&#xD;
          -  Alcoholics&#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>Yusuf BUKEY, Prof. MD</last_name>
    <role>Study Chair</role>
    <affiliation>Istanbul University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul University, Cerrahpasa Medical Faculty</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Serkan TEKSOZ</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</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/NCT02981095
org study id: IUCTF-EndSx-2010-01
nct id: NCT02981095
lead sponsor: 
has dmc: No
Investigators aimed to evaluate the impact of bupivacaine administration into the surgical
      field after total thyroidectomy on post-operative pain and analgesic requirement with a
      double-blind, prospective, clinical, randomized study.

      Pain assessment was performed with the visual analog score (VAS). Participants were
      pre-operatively, divided into two groups randomly to receive either bupivacaine or not. One
      group received a 10 ml of bupivacaine solution while the other group was treated with the
      same volume of 0.9% sodium chloride (NaCl) through the drain after completion of total
      thyroidectomy procedure. All participants were anesthetized and operated with the same
      anesthesia and surgical team.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Post-operative pain in 8 hours after surgery using VAS
time frame: 8th hour
description: Evaluation of the pain through the post-operative first 8 hours using VAS
measure: Post-operative pain in in first post-operative day using VAS
time frame: 1 day
description: Evaluation of the pain through the first post-operative day using VAS
arm group label: Bupivacaine
arm group type: Active Comparator
description: bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
arm group label: Saline
arm group type: Placebo Comparator
description: Saline solution (%0.9 sodium chloride), 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
intervention type: Procedure
intervention name: Thyroidectomy
description: Thyroidectomy performed by the same surgical and anesthesia team
arm group label: Bupivacaine
arm group label: Saline
intervention type: Drug
intervention name: Bupivacaine
description: bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
arm group label: Bupivacaine
intervention type: Drug
intervention name: Saline Solution
description: %0.9 sodium chloride solution, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
arm group label: Saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yusuf BUKEY, Prof. MD
role: Study Chair
affiliation: Istanbul University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Serkan TEKSOZ
investigator title: MD
mesh term: Thyroid Diseases
mesh term: Bupivacaine
sharing ipd: No