<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/NCT04427059</url>
  </required_header>
  <id_info>
    <org_study_id>ORL-CHIR-008</org_study_id>
    <nct_id>NCT04427059</nct_id>
  </id_info>
  <brief_title>A Study to Compare Two Techniques for Pain Control After Bariatric Surgery</brief_title>
  <official_title>Laparoscopic Assisted Transversus Abdominis Plane (TAP) Block Vs Local Anesthetic Infiltrations in Bariatric Surgery: a Prospective Randomized Double-Blind Controlled Trial (TAP BLOCK BARIATRIC TRIAL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fabio Garofalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ente Ospedaliero Cantonale, Bellinzona</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to compare the postoperative pain and other clinical outcomes in&#xD;
      patients who, during bariatric surgery, will be injected with a local anesthetic&#xD;
      (Ropivacaine) through two different techniques.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">July 7, 2021</completion_date>
  <primary_completion_date type="Actual">July 7, 2021</primary_completion_date>
  <phase>N/A</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>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>at 24 hours post surgery</time_frame>
    <description>Postoperative pain on the visual analogue scale (VAS) This visual analogue scale measures the subjective pain: patients indicate a position along a continuous line between two end-points to specify their level of pain. Absence of pain is represented by 0 while 10 corresponds to the maximum of pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>at 3, 6, 12, 18 hours from surgery</time_frame>
    <description>Postoperative pain on the visual analogue scale (VAS) at 3, 6, 12, 18 hours. This visual analogue scale measures the subjective pain: patients indicate a position along a continuous line between two end-points to specify their level of pain. Absence of pain is represented by 0 while 10 corresponds to the maximum of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Ropivacaine-Related Adverse Events</measure>
    <time_frame>from surgery up to six weeks after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with complications</measure>
    <time_frame>from surgery up to six weeks after surgery</time_frame>
    <description>Number of participants with complications, defined as any alteration from the normal or uneventful postoperative course,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lenght of hospital stay</measure>
    <time_frame>during hospitalization,approximately 4 days</time_frame>
    <description>number of days the participant is being hospitalized</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>in hospital satisfaction</measure>
    <time_frame>during hospitalization,approximately 4 days</time_frame>
    <description>In hospital satisfaction (measured on the validated Leiden Perioperative Patient Satisfaction -LPPS - questionnaire for the perioperative patients' satisfaction.&#xD;
This questionnaire assess patient satisfaction with perioperative care. Patients are asked to score each question on a fivepoint scale (from 1 - corresponding to the worse outcome to 5 - the best outcome)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">115</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>Arm A - laparoscopic assisted TAP block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo the planned bariatric intervention according to the standard of treatment. A solution of 20 ml of the local anesthetic Ropivacaine (0.25%) is then injected for postoperative pain control according to the allocated procedure (TPA).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B - PSI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo the planned bariatric intervention according to the standard of treatment. A solution of 20 ml of the local anesthetic Ropivacaine (0.25%) is then injected for postoperative pain control according to the allocated procedure (PSI).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transversus Abdominis Plane (TAP) block</intervention_name>
    <description>The laparoscopic-assisted Transversus Abdominis Plane (TAP) block will be done just after the optic trocar placement as follow: as landmarks we use the anterior axillary line, in the middle between the iliac crest and the costal margin. After insertion of the optic trocar the peritoneum is visualized. A 14 Gauge needle is inserted 2 cm cranially respect the taken landmark through the skin until the penetration of the internal and external oblique fascias, identified as sudden lowering of resistance. Laparoscopy allows to confirm that the needle did not pass the peritoneum.&#xD;
A solution of 20 ml of Ropivacaine (0.25%) is then injected, observing the formation of a bulge posterior to the transversus abdominis muscle.&#xD;
The procedure is then repeated identically on the contralateral side.</description>
    <arm_group_label>Arm A - laparoscopic assisted TAP block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Port-Site Infiltration (PSI)</intervention_name>
    <description>The Port-Site Infiltration (PSI) will be performed by infiltrating the subcutis and the skin at the trocar site before the trocar placements with a solution of local anesthetic (Ropivacaine 0.25%), a total of 40 ml will be administered.</description>
    <arm_group_label>Arm B - PSI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing elective bariatric surgery&#xD;
&#xD;
          -  age ≥ 18 years&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women,&#xD;
&#xD;
          -  known allergy to local anesthetics&#xD;
&#xD;
          -  Chronic pain syndrome.&#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>Fabio Garofalo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>EOC Surgeery Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ospedale Regionale di Lugano, Civico e Italiano</name>
      <address>
        <city>Lugano</city>
        <zip>6900</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>October 5, 2021</last_update_submitted>
  <last_update_submitted_qc>October 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ente Ospedaliero Cantonale, Bellinzona</investigator_affiliation>
    <investigator_full_name>Fabio Garofalo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Transversus Abdominis Plane (TAP) Block</keyword>
  <keyword>Local Anesthetic Infiltrations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04427059
org study id: ORL-CHIR-008
nct id: NCT04427059
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the postoperative pain and other clinical outcomes in
      patients who, during bariatric surgery, will be injected with a local anesthetic
      (Ropivacaine) through two different techniques.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Postoperative Pain
time frame: at 24 hours post surgery
description: Postoperative pain on the visual analogue scale (VAS) This visual analogue scale measures the subjective pain: patients indicate a position along a continuous line between two end-points to specify their level of pain. Absence of pain is represented by 0 while 10 corresponds to the maximum of pain.
measure: postoperative pain
time frame: at 3, 6, 12, 18 hours from surgery
description: Postoperative pain on the visual analogue scale (VAS) at 3, 6, 12, 18 hours. This visual analogue scale measures the subjective pain: patients indicate a position along a continuous line between two end-points to specify their level of pain. Absence of pain is represented by 0 while 10 corresponds to the maximum of pain.
measure: Number of Participants With Ropivacaine-Related Adverse Events
time frame: from surgery up to six weeks after surgery
measure: Number of participants with complications
time frame: from surgery up to six weeks after surgery
description: Number of participants with complications, defined as any alteration from the normal or uneventful postoperative course,
measure: lenght of hospital stay
time frame: during hospitalization,approximately 4 days
description: number of days the participant is being hospitalized
measure: in hospital satisfaction
time frame: during hospitalization,approximately 4 days
description: In hospital satisfaction (measured on the validated Leiden Perioperative Patient Satisfaction -LPPS - questionnaire for the perioperative patients' satisfaction.
This questionnaire assess patient satisfaction with perioperative care. Patients are asked to score each question on a fivepoint scale (from 1 - corresponding to the worse outcome to 5 - the best outcome)
arm group label: Arm A - laparoscopic assisted TAP block
arm group type: Experimental
description: Patients will undergo the planned bariatric intervention according to the standard of treatment. A solution of 20 ml of the local anesthetic Ropivacaine (0.25%) is then injected for postoperative pain control according to the allocated procedure (TPA).
arm group label: Arm B - PSI
arm group type: Active Comparator
description: Patients will undergo the planned bariatric intervention according to the standard of treatment. A solution of 20 ml of the local anesthetic Ropivacaine (0.25%) is then injected for postoperative pain control according to the allocated procedure (PSI).
intervention type: Procedure
intervention name: Transversus Abdominis Plane (TAP) block
description: The laparoscopic-assisted Transversus Abdominis Plane (TAP) block will be done just after the optic trocar placement as follow: as landmarks we use the anterior axillary line, in the middle between the iliac crest and the costal margin. After insertion of the optic trocar the peritoneum is visualized. A 14 Gauge needle is inserted 2 cm cranially respect the taken landmark through the skin until the penetration of the internal and external oblique fascias, identified as sudden lowering of resistance. Laparoscopy allows to confirm that the needle did not pass the peritoneum.
A solution of 20 ml of Ropivacaine (0.25%) is then injected, observing the formation of a bulge posterior to the transversus abdominis muscle.
The procedure is then repeated identically on the contralateral side.
arm group label: Arm A - laparoscopic assisted TAP block
intervention type: Procedure
intervention name: Port-Site Infiltration (PSI)
description: The Port-Site Infiltration (PSI) will be performed by infiltrating the subcutis and the skin at the trocar site before the trocar placements with a solution of local anesthetic (Ropivacaine 0.25%), a total of 40 ml will be administered.
arm group label: Arm B - PSI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fabio Garofalo, MD
role: Principal Investigator
affiliation: EOC Surgeery Department
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Ente Ospedaliero Cantonale, Bellinzona
investigator full name: Fabio Garofalo
investigator title: Principal Investigator
mesh term: Pain, Postoperative
sharing ipd: No