xml: <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/NCT06014749</url>
    </required_header>
    <id_info>
      <org_study_id>22-EO132</org_study_id>
      <nct_id>NCT06014749</nct_id>
    </id_info>
    <brief_title>Serratus Intercostal Block Versus Epidural Analgesia in Eventration: Prospective Observational Study</brief_title>
    <official_title>Analgesic Efficacy of Serratus Intercostal Block Versus Epidural Analgesia in Eventration Surgery : Prospective Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital del Río Hortega</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospital del Río Hortega</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Adequate pain control, rehabilitation and early postoperative recovery are currently the&#xD;
        model to follow according to the recommended guidelines.In this project the main objective is&#xD;
        to evaluate 2 different analgesic strategies both intraoperatively and postoperatively, one&#xD;
        based on 1. Epidural analgesia and the other 2. Echoguided serratus intercostal block prior&#xD;
        to surgical intervention in eventration or abdominal wall repair interventions.&#xD;
  &#xD;
        We conducted an observational study with a low level of intervention. Epidural analgesia&#xD;
        prior to general anesthesia and serratus-intercostal block prior to general anesthesia)&#xD;
        following the criteria applied in each case according to the operating room anesthesiologist&#xD;
        until reaching the sample size and fulfilling the criteria of: abdominal eventration repair,&#xD;
        over 18 years of age, ASA I-III. Signature of the IC.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Adequate pain control, rehabilitation and early postoperative recovery are currently model to&#xD;
        follow according to the recommended guidelines.In this project the main objective is to&#xD;
        evaluate 2 different analgesic strategies both intraoperatively and postoperatively, one&#xD;
        based on 1. Epidural analgesia and the other 2. Echoguided serratus intercostal block prior&#xD;
        to surgical intervention in eventration or abdominal wall repair interventions.&#xD;
  &#xD;
        The investigators conducted an observational study with a low level of intervention. Epidural&#xD;
        analgesia prior to general anesthesia and serratus-intercostal block prior to general&#xD;
        anesthesia) following the criteria applied in each case according to the operating room&#xD;
        anesthesiologist until reaching the sample size and fulfilling the criteria of: abdominal&#xD;
        eventration repair, over 18 years of age, ASA I-III. Signature of the IC.&#xD;
  &#xD;
        We will assess the analgesia provided by both techniques and to compare the results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Actual">August 1, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>2 Years</target_duration>
    <primary_outcome>
      <measure>postoperative pain management</measure>
      <time_frame>24h</time_frame>
      <description>Pain control. NRS scale at O,6, 12 and 24 h in postoperative time</description>
    </primary_outcome>
    <primary_outcome>
      <measure>postoperative quality of recovery</measure>
      <time_frame>24h</time_frame>
      <description>Quality of recovery, QoR15 scale, that includes physical and psicological item. That scale will be fill by the patient 24 h after surgery</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Eventration</condition>
    <condition>Regional Anesthesia</condition>
    <condition>Epidural; Anesthesia</condition>
    <condition>Abdominal Hernia</condition>
    <arm_group>
      <arm_group_label>Patient under serratus intercostal plane block</arm_group_label>
      <description>patients who will undergo a modified bilateral ultrasound-guided BRILMA block (SIPB) using a high-frequency linear probe (6-15 Hz) and 80 mm needle.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>patient under epidural analgesia</arm_group_label>
      <description>patients who undergo Epidural Analgesia prior to General Anesthesia and fentanyl 1 mcg/kg approx according to characteristics and needs and upon arrival at the URPA is connected to the PC Levobupi 0.125% at 6 ml / h + rescue boluses of Levobupi 0.125% 4 ml if needed in the 1st hours.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>undergo</intervention_name>
      <description>regional anesthesia</description>
      <arm_group_label>Patient under serratus intercostal plane block</arm_group_label>
      <arm_group_label>patient under epidural analgesia</arm_group_label>
      <other_name>Eventroplasty</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ultrasound</intervention_name>
      <description>ultrasound guided</description>
      <arm_group_label>Patient under serratus intercostal plane block</arm_group_label>
      <arm_group_label>patient under epidural analgesia</arm_group_label>
      <other_name>Regional anesthesia</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Local anesthetic</intervention_name>
      <description>local anesthetic</description>
      <arm_group_label>Patient under serratus intercostal plane block</arm_group_label>
      <arm_group_label>patient under epidural analgesia</arm_group_label>
      <other_name>Regional anesthesia</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          people undergoing to repair abdominal wall&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  abdominal eventration repair,&#xD;
  &#xD;
            -  over 18 years old,&#xD;
  &#xD;
            -  ASA I-III.&#xD;
  &#xD;
            -  Signature of the IC.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Allergy to Local anesthetic&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>María T Fernandez, MD</last_name>
      <role>Study Director</role>
      <affiliation>Hospital del Río Hortega</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>judith Andres, MD</last_name>
      <phone>+34661633123</phone>
      <email>jandressa@saludcastillayleon.es</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>María T Fernandez, MD</last_name>
      <phone>+34637571685</phone>
      <email>maitefm70@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Judith Andres</name>
        <address>
          <city>Valladolid</city>
          <state>Castilla Y León</state>
          <zip>47008</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>María Teresa F Martín</last_name>
        <phone>637571685</phone>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hospital del Río Hortega</investigator_affiliation>
      <investigator_full_name>Judith Andres</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <keyword>Intercostal nerves, epidural,abdominal hernia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastroschisis</mesh_term>
      <mesh_term>Hernia, Umbilical</mesh_term>
      <mesh_term>Hernia</mesh_term>
      <mesh_term>Hernia, Abdominal</mesh_term>
      <mesh_term>Internal Hernia</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anesthetics</mesh_term>
      <mesh_term>Anesthetics, Local</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>During the first year the preliminary results will be ready and will be present as abstract. Th estimated time to finish the study is 2 years</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014749
  org study id: 22-EO132
  nct id: NCT06014749
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: Yes
  is us export: No
  Adequate pain control, rehabilitation and early postoperative recovery are currently the
        model to follow according to the recommended guidelines.In this project the main objective is
        to evaluate 2 different analgesic strategies both intraoperatively and postoperatively, one
        based on 1. Epidural analgesia and the other 2. Echoguided serratus intercostal block prior
        to surgical intervention in eventration or abdominal wall repair interventions.
  
        We conducted an observational study with a low level of intervention. Epidural analgesia
        prior to general anesthesia and serratus-intercostal block prior to general anesthesia)
        following the criteria applied in each case according to the operating room anesthesiologist
        until reaching the sample size and fulfilling the criteria of: abdominal eventration repair,
        over 18 years of age, ASA I-III. Signature of the IC.
  Adequate pain control, rehabilitation and early postoperative recovery are currently model to
        follow according to the recommended guidelines.In this project the main objective is to
        evaluate 2 different analgesic strategies both intraoperatively and postoperatively, one
        based on 1. Epidural analgesia and the other 2. Echoguided serratus intercostal block prior
        to surgical intervention in eventration or abdominal wall repair interventions.
  
        The investigators conducted an observational study with a low level of intervention. Epidural
        analgesia prior to general anesthesia and serratus-intercostal block prior to general
        anesthesia) following the criteria applied in each case according to the operating room
        anesthesiologist until reaching the sample size and fulfilling the criteria of: abdominal
        eventration repair, over 18 years of age, ASA I-III. Signature of the IC.
  
        We will assess the analgesia provided by both techniques and to compare the results.
  observational model: Case-Control
  time perspective: Prospective
  measure: postoperative pain management
  time frame: 24h
  description: Pain control. NRS scale at O,6, 12 and 24 h in postoperative time
  measure: postoperative quality of recovery
  time frame: 24h
  description: Quality of recovery, QoR15 scale, that includes physical and psicological item. That scale will be fill by the patient 24 h after surgery
  arm group label: Patient under serratus intercostal plane block
  description: patients who will undergo a modified bilateral ultrasound-guided BRILMA block (SIPB) using a high-frequency linear probe (6-15 Hz) and 80 mm needle.
  arm group label: patient under epidural analgesia
  description: patients who undergo Epidural Analgesia prior to General Anesthesia and fentanyl 1 mcg/kg approx according to characteristics and needs and upon arrival at the URPA is connected to the PC Levobupi 0.125% at 6 ml / h + rescue boluses of Levobupi 0.125% 4 ml if needed in the 1st hours.
  intervention type: Procedure
  intervention name: undergo
  description: regional anesthesia
  arm group label: Patient under serratus intercostal plane block
  arm group label: patient under epidural analgesia
  other name: Eventroplasty
  intervention type: Device
  intervention name: ultrasound
  description: ultrasound guided
  arm group label: Patient under serratus intercostal plane block
  arm group label: patient under epidural analgesia
  other name: Regional anesthesia
  intervention type: Drug
  intervention name: Local anesthetic
  description: local anesthetic
  arm group label: Patient under serratus intercostal plane block
  arm group label: patient under epidural analgesia
  other name: Regional anesthesia
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  last name: María T Fernandez, MD
  role: Study Director
  affiliation: Hospital del Río Hortega
  last name: judith Andres, MD
  phone: +34661633123
  email: jandressa@saludcastillayleon.es
  last name: María T Fernandez, MD
  phone: +34637571685
  email: maitefm70@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Hospital del Río Hortega
  investigator full name: Judith Andres
  investigator title: MD
  mesh term: Gastroschisis
  mesh term: Hernia, Umbilical
  mesh term: Hernia
  mesh term: Hernia, Abdominal
  mesh term: Internal Hernia
  mesh term: Anesthetics
  mesh term: Anesthetics, Local
  sharing ipd: Undecided
  ipd description: During the first year the preliminary results will be ready and will be present as abstract. Th estimated time to finish the study is 2 years