<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/NCT03805269</url>
  </required_header>
  <id_info>
    <org_study_id>SNUBHTAP</org_study_id>
    <nct_id>NCT03805269</nct_id>
  </id_info>
  <brief_title>Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration</brief_title>
  <official_title>Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration in Adult Patients Undergoing Single Incision Laparoscopic Gastrectomy: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Bundang Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      There have been some studies to compared trans abdominis plane(TAP) block with wound&#xD;
      infiltration of local anesthetics in multiport laparoscopic surgery, but there have been no&#xD;
      studies in single incision laparoscopic gastrectomy.&#xD;
&#xD;
      The purpose of this study was to compare the effect of ultrasonography-guided transverse&#xD;
      nerve block and localized anesthesia infiltration in patients with single incision&#xD;
      laparoscopic gastrectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients were randomly divided into group N(ultrasonography-guided TAP) block and group W(&#xD;
      before surgery local anesthetic infiltration at the incision site). We compared the opioid&#xD;
      usage, postoperative 6, 24, and 48 hours pain, presence of vomiting, and duration of&#xD;
      hospitalization during the operation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 14, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 28, 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>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>post operative pain score</measure>
    <time_frame>4 hours after end of surgery</time_frame>
    <description>100 mm scale of visual analogue scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>post operative opioid consumption</measure>
    <time_frame>4 hours after end of surgery</time_frame>
    <description>total amount of opioid</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">94</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>TAP block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>USG guided TAP block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>wound infiltration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>local anesthetics infiltration at surgical incision site</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAP block</intervention_name>
    <description>TAP block: local anesthetics infiltration at trans abdominis plane</description>
    <arm_group_label>TAP block</arm_group_label>
    <other_name>TAP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>wound infiltration</intervention_name>
    <description>wound infiltration: local anesthetics infiltration at surgical incision</description>
    <arm_group_label>wound infiltration</arm_group_label>
    <other_name>Wound</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA class I-II&#xD;
&#xD;
          -  Age: &gt;18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients of severe kidney &amp; liver dysfunction&#xD;
&#xD;
          -  allergy of local anesthetics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jung-hi Ryu, Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bon-Wook Koo, Dr.</last_name>
    <phone>+82-10-7227-1379</phone>
    <email>tendong2@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National Universuty, Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyonggido</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bon-Wook Koo, MD</last_name>
      <phone>+82-10-7227-1379</phone>
      <email>tendong2@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 12, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>April 23, 2021</last_update_submitted>
  <last_update_submitted_qc>April 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>BON WOOK KOO</investigator_full_name>
    <investigator_title>asociative professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <!-- 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/NCT03805269
org study id: SNUBHTAP
nct id: NCT03805269
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
There have been some studies to compared trans abdominis plane(TAP) block with wound
      infiltration of local anesthetics in multiport laparoscopic surgery, but there have been no
      studies in single incision laparoscopic gastrectomy.

      The purpose of this study was to compare the effect of ultrasonography-guided transverse
      nerve block and localized anesthesia infiltration in patients with single incision
      laparoscopic gastrectomy.
Patients were randomly divided into group N(ultrasonography-guided TAP) block and group W(
      before surgery local anesthetic infiltration at the incision site). We compared the opioid
      usage, postoperative 6, 24, and 48 hours pain, presence of vomiting, and duration of
      hospitalization during the operation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: post operative pain score
time frame: 4 hours after end of surgery
description: 100 mm scale of visual analogue scale
measure: post operative opioid consumption
time frame: 4 hours after end of surgery
description: total amount of opioid
arm group label: TAP block
arm group type: Experimental
description: USG guided TAP block
arm group label: wound infiltration
arm group type: Active Comparator
description: local anesthetics infiltration at surgical incision site
intervention type: Drug
intervention name: TAP block
description: TAP block: local anesthetics infiltration at trans abdominis plane
arm group label: TAP block
other name: TAP
intervention type: Drug
intervention name: wound infiltration
description: wound infiltration: local anesthetics infiltration at surgical incision
arm group label: wound infiltration
other name: Wound
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Jung-hi Ryu, Dr.
role: Study Chair
affiliation: Seoul National University Bundang Hospital
last name: Bon-Wook Koo, Dr.
phone: +82-10-7227-1379
email: tendong2@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: BON WOOK KOO
investigator title: asociative professor
mesh term: Pain, Postoperative