<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/NCT03830086</url>
  </required_header>
  <id_info>
    <org_study_id>160/2016/O/Oss</org_study_id>
    <nct_id>NCT03830086</nct_id>
  </id_info>
  <brief_title>Regional Anesthesia Versus General Anesthesia</brief_title>
  <official_title>Regional Anesthesia Versus General Anesthesia in Patients Undergoing Laparoscopic Gynecological Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Azienda Ospedaliero-Universitaria di Bologna</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients undergoing laparoscopic gynecological surgery will receive regional anesthesia or&#xD;
      general anesthesia with endotracheal intubation. The investigators aim to evaluate the&#xD;
      feasibility and safety of regional anesthesia for laparoscopic gynecological procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Commonly, laparoscopic gynecological procedures are performed under general anesthesia with&#xD;
      endotracheal intubation.&#xD;
&#xD;
      The use of regional anesthesia in laparoscopy is reserved to patients declared unfit for&#xD;
      general anesthesia because of severe comorbidities or it is applied in combination with&#xD;
      general anesthesia to decrease postoperative pain.&#xD;
&#xD;
      Recently, growing literature evidence supports the use of regional anesthesia in patients&#xD;
      undergoing laparoscopy.&#xD;
&#xD;
      The combination of minimally invasive surgery with regional anesthesia could increase the&#xD;
      advantages of laparoscopic operations (less postoperative pain, shorter hospital stay, etc).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)</measure>
    <time_frame>From the surgery time, assessed up to 7 days after surgery</time_frame>
    <description>Evaluation of feasibility and safety of regional anesthesia for gynecological laparoscopic surgery, considering complications using Clavien-Dindo Classification (from Grade I to V)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative nausea or emesis.</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>evaluation of the presence of postoperative nausea or emesis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of hospitalization</measure>
    <time_frame>From surgery to hospitalization discharge, assessed up to 7 days after surgery.</time_frame>
    <description>Number of days of hospitalization after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of mobilization.</measure>
    <time_frame>From surgery to day of first mobilization, assessed up to 7 days after surgery.</time_frame>
    <description>Day of first mobilization after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of feeding.</measure>
    <time_frame>From surgery to day of first feeding, assessed up to 7 days after surgery.</time_frame>
    <description>Day of first feeding after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Day of canalization.</measure>
    <time_frame>From surgery to day of first canalization, assessed up to 7 days after surgery.</time_frame>
    <description>Day of first canalization after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative pain: verbal numeric rating scale</measure>
    <time_frame>Intraoperative: from skin incision to cutaneous suture.</time_frame>
    <description>Intraoperative pain in patients submitted to regional anesthesia (Group B), using a verbal numeric rating scale, from 0 to 10, where 0 is no pain and 10 is the worse pain ever</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum respiratory rate</measure>
    <time_frame>Intraoperative: from skin incision to cutaneous suture.</time_frame>
    <description>Minimum respiratory rate during surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End-Tidal PCO2 before pneumoperitoneum.</measure>
    <time_frame>Intraoperative: from anesthesia to the beginning of pneumoperitoneum induction.</time_frame>
    <description>End-Tidal PCO2 is measured by capnography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End-Tidal PCO2 during pneumoperitoneum.</measure>
    <time_frame>Intraoperative: pneumoperitoneum time expressed in minutes.</time_frame>
    <description>End-Tidal PCO2 is measured by capnography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain: numerical rating scale</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>Evaluation of postoperative pain in patients undergoing general or regional anesthesia for gynecological laparoscopic surgery, measured with verbal numerical rating scale, from 0 to 10, where 0 is no pain and 10 is the worse pain ever</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Group A: general anesthesia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: regional anesthesia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients undergoing gynecological laparoscopic surgery under regional anesthesia, using the following drugs: Sufentanil, Bupivacaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>Used for general anesthesia for gynecological laparoscopic procedures, together with Propofol, Sufentanil, Rocuronium, Sevoflurane</description>
    <arm_group_label>Group A: general anesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sufentanil</intervention_name>
    <description>Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures together with Bupivacaine; and for general anesthesia for gynecological laparoscopic procedures, together with following drugs: Midazolam, Propofol, Rocuronium, Sevoflurane</description>
    <arm_group_label>Group A: general anesthesia</arm_group_label>
    <arm_group_label>Group B: regional anesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Sufentanil, Rocuronium, Sevoflurane</description>
    <arm_group_label>Group A: general anesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium</intervention_name>
    <description>Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Sevoflurane</description>
    <arm_group_label>Group A: general anesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <description>Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium</description>
    <arm_group_label>Group A: general anesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures, together with Sufentanil</description>
    <arm_group_label>Group B: regional anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing gynecological laparoscopic surgery;&#xD;
&#xD;
          -  expected surgical time shorter than 90 minutes;&#xD;
&#xD;
          -  informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria: none.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cardiothoracic and Vascular Anesthesia and Intensive Care, S. OrsolaMalpighi University Hospital</name>
      <address>
        <city>Bologna</city>
        <state>BO</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital</name>
      <address>
        <city>Bologna</city>
        <state>BO</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>July 12, 2019</last_update_submitted>
  <last_update_submitted_qc>July 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</investigator_affiliation>
    <investigator_full_name>Mohamed Mabrouk</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>postoperative pain</keyword>
  <keyword>regional anesthesia</keyword>
  <keyword>general anesthesia</keyword>
  <keyword>gynecological laparoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Sufentanil</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
    <mesh_term>Rocuronium</mesh_term>
  </intervention_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/NCT03830086
org study id: 160/2016/O/Oss
nct id: NCT03830086
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Patients undergoing laparoscopic gynecological surgery will receive regional anesthesia or
      general anesthesia with endotracheal intubation. The investigators aim to evaluate the
      feasibility and safety of regional anesthesia for laparoscopic gynecological procedures.
Commonly, laparoscopic gynecological procedures are performed under general anesthesia with
      endotracheal intubation.

      The use of regional anesthesia in laparoscopy is reserved to patients declared unfit for
      general anesthesia because of severe comorbidities or it is applied in combination with
      general anesthesia to decrease postoperative pain.

      Recently, growing literature evidence supports the use of regional anesthesia in patients
      undergoing laparoscopy.

      The combination of minimally invasive surgery with regional anesthesia could increase the
      advantages of laparoscopic operations (less postoperative pain, shorter hospital stay, etc).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)
time frame: From the surgery time, assessed up to 7 days after surgery
description: Evaluation of feasibility and safety of regional anesthesia for gynecological laparoscopic surgery, considering complications using Clavien-Dindo Classification (from Grade I to V)
measure: Postoperative nausea or emesis.
time frame: 48 hours after surgery
description: evaluation of the presence of postoperative nausea or emesis.
measure: Days of hospitalization
time frame: From surgery to hospitalization discharge, assessed up to 7 days after surgery.
description: Number of days of hospitalization after surgery.
measure: Day of mobilization.
time frame: From surgery to day of first mobilization, assessed up to 7 days after surgery.
description: Day of first mobilization after surgery.
measure: Day of feeding.
time frame: From surgery to day of first feeding, assessed up to 7 days after surgery.
description: Day of first feeding after surgery.
measure: Day of canalization.
time frame: From surgery to day of first canalization, assessed up to 7 days after surgery.
description: Day of first canalization after surgery.
measure: Intraoperative pain: verbal numeric rating scale
time frame: Intraoperative: from skin incision to cutaneous suture.
description: Intraoperative pain in patients submitted to regional anesthesia (Group B), using a verbal numeric rating scale, from 0 to 10, where 0 is no pain and 10 is the worse pain ever
measure: Minimum respiratory rate
time frame: Intraoperative: from skin incision to cutaneous suture.
description: Minimum respiratory rate during surgery.
measure: End-Tidal PCO2 before pneumoperitoneum.
time frame: Intraoperative: from anesthesia to the beginning of pneumoperitoneum induction.
description: End-Tidal PCO2 is measured by capnography.
measure: End-Tidal PCO2 during pneumoperitoneum.
time frame: Intraoperative: pneumoperitoneum time expressed in minutes.
description: End-Tidal PCO2 is measured by capnography.
measure: Postoperative pain: numerical rating scale
time frame: 48 hours after surgery
description: Evaluation of postoperative pain in patients undergoing general or regional anesthesia for gynecological laparoscopic surgery, measured with verbal numerical rating scale, from 0 to 10, where 0 is no pain and 10 is the worse pain ever
arm group label: Group A: general anesthesia
arm group type: Other
description: Patients undergoing gynecological laparoscopic surgery under general anesthesia, using the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium, Sevoflurane
arm group label: Group B: regional anesthesia
arm group type: Other
description: Patients undergoing gynecological laparoscopic surgery under regional anesthesia, using the following drugs: Sufentanil, Bupivacaine
intervention type: Drug
intervention name: Midazolam
description: Used for general anesthesia for gynecological laparoscopic procedures, together with Propofol, Sufentanil, Rocuronium, Sevoflurane
arm group label: Group A: general anesthesia
intervention type: Drug
intervention name: Sufentanil
description: Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures together with Bupivacaine; and for general anesthesia for gynecological laparoscopic procedures, together with following drugs: Midazolam, Propofol, Rocuronium, Sevoflurane
arm group label: Group A: general anesthesia
arm group label: Group B: regional anesthesia
intervention type: Drug
intervention name: Propofol
description: Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Sufentanil, Rocuronium, Sevoflurane
arm group label: Group A: general anesthesia
intervention type: Drug
intervention name: Rocuronium
description: Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Sevoflurane
arm group label: Group A: general anesthesia
intervention type: Drug
intervention name: Sevoflurane
description: Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium
arm group label: Group A: general anesthesia
intervention type: Drug
intervention name: Bupivacaine
description: Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures, together with Sufentanil
arm group label: Group B: regional anesthesia
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: Mohamed Mabrouk
investigator title: Principal Investigator
mesh term: Pain, Postoperative
mesh term: Midazolam
mesh term: Sufentanil
mesh term: Bupivacaine
mesh term: Propofol
mesh term: Sevoflurane
mesh term: Rocuronium