<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/NCT03007927</url>
  </required_header>
  <id_info>
    <org_study_id>2736</org_study_id>
    <nct_id>NCT03007927</nct_id>
  </id_info>
  <brief_title>Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh</brief_title>
  <official_title>Evaluation of Dexamethasone Added to the Usual Infiltration With Bupivacaine in Inguinal Hernia Repair Mesh</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SEBASTIAN ROCHE</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sebastián Roche, MD</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Santiago Bertone, MD</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Claudio Brandi, MD</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Italiano de Buenos Aires</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the impact on the postoperative pain of the dexamethasone addition to the usual&#xD;
      treatment with bupivacaine in the local infiltration of the surgical area in Inguinal Hernia&#xD;
      Repair Mesh&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be: controlled, prospective, randomized and double blind.&#xD;
&#xD;
      Randomized experimental study in which all patients scheduled to undergo unilateral inguinal&#xD;
      hernia repair and who meet the inclusion criteria and none of the exclusion criteria will be&#xD;
      invited to participate. At the time of admission to the study, they were assigned randomly to&#xD;
      one of the two branches of intervention:&#xD;
&#xD;
      (Group A): infiltration with 0.5% bupivacaine in doses of 1.5 mg / kg body weight diluted in&#xD;
      physiological solution to a final volume of 30 ml.&#xD;
&#xD;
      (Group B): infiltration with 0.5% bupivacaine at doses of 1.5 mg / kg body weight +&#xD;
      dexamethasone 2 ml (8 mg) diluted in physiological solution to a final volume of 30 ml.&#xD;
&#xD;
      Pain will be evaluated through the visual analogue scale of 0-10 measured at the 1st&#xD;
      postoperative hour, then every 2 hours until discharge, at discharge, at 8 hours, at 24&#xD;
      hours, 48 hours and at 8 days .&#xD;
&#xD;
      It will also evaluate analgesic consumption, complications and labor return&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">June 29, 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain postoperative</measure>
    <time_frame>3 month</time_frame>
    <description>It will be used a 10cm ruler which will allows the patients indicates how much pain they are feeling at the moment, where 0 is no pain at all and 10 is the maximum imaginable pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>take analgesic</measure>
    <time_frame>1 month</time_frame>
    <description>Medication journal completed by patient</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Bupivacaine-Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>bupivacaine 1,5 mg/kg + dexamethasone 8 mg 2ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivacaine- physiological solution</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bupivacaine 1,5 mg/kg + physiological solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine-Dexamethasone</intervention_name>
    <description>Bupivacaine 1,5 mg/kg-Dexamethasone 2ml 8 mg</description>
    <arm_group_label>Bupivacaine-Dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine- physiological solution</intervention_name>
    <description>Bupivacaine 1,5 mg/kg- physiological solution</description>
    <arm_group_label>Bupivacaine- physiological solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients older than 18 years.&#xD;
&#xD;
          2. Unilateral inguinal hernioplasty.&#xD;
&#xD;
          3. That the surgery is performed in the Ambulatory Surgery Unit (UCA).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Recurrent hernia.&#xD;
&#xD;
          2. allergies, ongoing infections, diabetes.&#xD;
&#xD;
          3. Background of rejection of prosthetic material (mesh).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sebastian SR Roche, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Italiano de Buenos Aires</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Italiano de Buenos Aires, Peron 4190</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Capital Federal</state>
        <zip>C1199ABB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>February 20, 2018</last_update_submitted>
  <last_update_submitted_qc>February 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Italiano de Buenos Aires</investigator_affiliation>
    <investigator_full_name>SEBASTIAN ROCHE</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>pain</keyword>
  <keyword>hernia repair</keyword>
  <keyword>Dexamethasone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03007927
org study id: 2736
nct id: NCT03007927
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
To evaluate the impact on the postoperative pain of the dexamethasone addition to the usual
      treatment with bupivacaine in the local infiltration of the surgical area in Inguinal Hernia
      Repair Mesh
This study will be: controlled, prospective, randomized and double blind.

      Randomized experimental study in which all patients scheduled to undergo unilateral inguinal
      hernia repair and who meet the inclusion criteria and none of the exclusion criteria will be
      invited to participate. At the time of admission to the study, they were assigned randomly to
      one of the two branches of intervention:

      (Group A): infiltration with 0.5% bupivacaine in doses of 1.5 mg / kg body weight diluted in
      physiological solution to a final volume of 30 ml.

      (Group B): infiltration with 0.5% bupivacaine at doses of 1.5 mg / kg body weight +
      dexamethasone 2 ml (8 mg) diluted in physiological solution to a final volume of 30 ml.

      Pain will be evaluated through the visual analogue scale of 0-10 measured at the 1st
      postoperative hour, then every 2 hours until discharge, at discharge, at 8 hours, at 24
      hours, 48 hours and at 8 days .

      It will also evaluate analgesic consumption, complications and labor return
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: pain postoperative
time frame: 3 month
description: It will be used a 10cm ruler which will allows the patients indicates how much pain they are feeling at the moment, where 0 is no pain at all and 10 is the maximum imaginable pain.
measure: take analgesic
time frame: 1 month
description: Medication journal completed by patient
arm group label: Bupivacaine-Dexamethasone
arm group type: Experimental
description: bupivacaine 1,5 mg/kg + dexamethasone 8 mg 2ml
arm group label: Bupivacaine- physiological solution
arm group type: Active Comparator
description: bupivacaine 1,5 mg/kg + physiological solution
intervention type: Drug
intervention name: Bupivacaine-Dexamethasone
description: Bupivacaine 1,5 mg/kg-Dexamethasone 2ml 8 mg
arm group label: Bupivacaine-Dexamethasone
intervention type: Drug
intervention name: Bupivacaine- physiological solution
description: Bupivacaine 1,5 mg/kg- physiological solution
arm group label: Bupivacaine- physiological solution
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sebastian SR Roche, doctor
role: Principal Investigator
affiliation: Hospital Italiano de Buenos Aires
facility: 
country: Argentina
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital Italiano de Buenos Aires
investigator full name: SEBASTIAN ROCHE
investigator title: Medical Doctor
mesh term: Hernia
mesh term: Pain, Postoperative
mesh term: Hernia, Inguinal
mesh term: Dexamethasone
mesh term: Bupivacaine
sharing ipd: Yes