<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/NCT03775018</url>
  </required_header>
  <id_info>
    <org_study_id>HRJC 18-14</org_study_id>
    <nct_id>NCT03775018</nct_id>
  </id_info>
  <brief_title>TAP Blockade for Pain Control in One-Anastomosis Gastric Bypass</brief_title>
  <official_title>Transversus Abdominis Plane (TAP) Blockade as Multimodal Analgesia for Pain Control in One-Anastomosis Gastric Bypass (OAGB)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Universitario Elche</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Elche</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Patients will be randomized into 2 groups:&#xD;
&#xD;
        -  TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen&#xD;
           analgesia&#xD;
&#xD;
        -  IV: Patients receiving only intravenous Acetaminophen analgesia&#xD;
&#xD;
      Postoperative pain 24 hours after surgery will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomized into 2 groups:&#xD;
&#xD;
        -  TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen&#xD;
           analgesia (1g/6h)&#xD;
&#xD;
        -  IV: Patients receiving only intravenous Acetaminophen analgesia (1g/6h)&#xD;
&#xD;
      Postoperative pain 24 hours after surgery will be evaluated, by a Visual Analogic Scale&#xD;
      (VAS), ranging from 0 to 100mm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 13, 2018</start_date>
  <completion_date type="Anticipated">April 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2019</primary_completion_date>
  <phase>Phase 3</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, Outcomes Assessor)</masking>
    <masking_description>The analgesic treatment applied will be blinded to the treatment and to the epidemiology nurse who will assess the postoperative pain</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Pain will be assessed 24 hours after surgery by a Visual Analogic Scale, ranging from 0 to 100mm</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Transversus abdominis plain blockade</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous analgesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients will receive intravenous analgesia with Acetaminophen (1g/6h)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transversus abdominis plane blockade</intervention_name>
    <description>Patients will undergo Transversus abdominis plane blockade with Bupivacaine 0.25% 30ml, applied in the plane between the internal oblique muscle and the trasnversus abdominis. The injection will be performed laterally to the port-sites, bilaterally at the same levels.</description>
    <arm_group_label>Transversus abdominis plain blockade</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous analgesia</intervention_name>
    <description>Acetaminophen 1g/6h iv will be administered</description>
    <arm_group_label>Intravenous analgesia</arm_group_label>
    <arm_group_label>Transversus abdominis plain blockade</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing One-anastomosis gastric bypass (OAGB) as primary bariatric&#xD;
             procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing OAGB as revisional procedure&#xD;
&#xD;
          -  Patients undergoing other bariatric procedures&#xD;
&#xD;
          -  Patients undergoing additional surgical procedures during the same surgical act (band&#xD;
             removal, cholecystectomy, hernioplasty, or hiatal hernia treatment)&#xD;
&#xD;
          -  Patients with history of allegy to local anesthetic drugs&#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>Damian Garcia, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Rey Juan Carlos</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jaime Ruiz-Tovar, MD, PhD</last_name>
    <phone>(0034)630534808</phone>
    <email>jruiztovar@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Manuel Duran, MD, PhD</last_name>
    <phone>(0034)682357456</phone>
    <email>manuel.duran@hrjc.es</email>
  </overall_contact_backup>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>December 12, 2018</last_update_submitted>
  <last_update_submitted_qc>December 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Elche</investigator_affiliation>
    <investigator_full_name>Jaime Ruiz-Tovar, MD, PhD</investigator_full_name>
    <investigator_title>Department of Surgery</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/NCT03775018
org study id: HRJC 18-14
nct id: NCT03775018
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients will be randomized into 2 groups:

        -  TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen
           analgesia

        -  IV: Patients receiving only intravenous Acetaminophen analgesia

      Postoperative pain 24 hours after surgery will be evaluated.
Patients will be randomized into 2 groups:

        -  TAP: Patients undergoing TAP blockade, associated with intravenous Acetaminophen
           analgesia (1g/6h)

        -  IV: Patients receiving only intravenous Acetaminophen analgesia (1g/6h)

      Postoperative pain 24 hours after surgery will be evaluated, by a Visual Analogic Scale
      (VAS), ranging from 0 to 100mm.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The analgesic treatment applied will be blinded to the treatment and to the epidemiology nurse who will assess the postoperative pain
measure: Postoperative pain
time frame: 24 hours after surgery
description: Pain will be assessed 24 hours after surgery by a Visual Analogic Scale, ranging from 0 to 100mm
arm group label: Transversus abdominis plain blockade
arm group type: Experimental
description: The patients will undergo Transversus abdominis plain blockade, associated with intravenous analgesia
arm group label: Intravenous analgesia
arm group type: Active Comparator
description: The patients will receive intravenous analgesia with Acetaminophen (1g/6h)
intervention type: Procedure
intervention name: Transversus abdominis plane blockade
description: Patients will undergo Transversus abdominis plane blockade with Bupivacaine 0.25% 30ml, applied in the plane between the internal oblique muscle and the trasnversus abdominis. The injection will be performed laterally to the port-sites, bilaterally at the same levels.
arm group label: Transversus abdominis plain blockade
intervention type: Drug
intervention name: Intravenous analgesia
description: Acetaminophen 1g/6h iv will be administered
arm group label: Intravenous analgesia
arm group label: Transversus abdominis plain blockade
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Damian Garcia, MD, PhD
role: Study Director
affiliation: Hospital Rey Juan Carlos
last name: Jaime Ruiz-Tovar, MD, PhD
phone: (0034)630534808
email: jruiztovar@gmail.com
last name: Manuel Duran, MD, PhD
phone: (0034)682357456
email: manuel.duran@hrjc.es
responsible party type: Principal Investigator
investigator affiliation: Hospital General Universitario Elche
investigator full name: Jaime Ruiz-Tovar, MD, PhD
investigator title: Department of Surgery
mesh term: Pain, Postoperative