<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/NCT03030677</url>
  </required_header>
  <id_info>
    <org_study_id>MMSTD1Pecs2</org_study_id>
    <nct_id>NCT03030677</nct_id>
  </id_info>
  <brief_title>Establishing Technique for PECS2 Catheter Insertion</brief_title>
  <acronym>ETCI</acronym>
  <official_title>Establishing Technique for PECS Type 2 (Serratus Block) Catheter Insertion With Ultrasound Guidence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</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>
      The investigators are trying to establish an easy technique for insertion of a catheter for&#xD;
      continuous infusion while performing pectoral type 2 (serratus) block, as a post operative&#xD;
      pain controlling measure for cases undergoing simple mastectomy, using ultrasound guidence&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As the space between the pectoralis minor and the serratus anterior is a fashial plane with a&#xD;
      connective tissue occupying. we are trying to demonstrate a simple technique for inserting a&#xD;
      catheter within that fashial plane and making sure of the catheter position, to ensure post&#xD;
      operative analgesia for cases performing simple mastectomy.&#xD;
&#xD;
      Now the Pectoralis type 2 block (PECS type 2) is an established technique as regional block&#xD;
      technique for chest wall procedures.&#xD;
&#xD;
      We are trying to maximizing the benefit of the block with a catheter insertion to use it for&#xD;
      continuous infusion of bupivacaine for controlling post operative pain in cases performing&#xD;
      simple mastectomy procedure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 31, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>successful catheter insertion</measure>
    <time_frame>during time of performing the block</time_frame>
    <description>confirming catheter insertion 5 cm beyond the tip of needle in the proper plan using ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of attempts</measure>
    <time_frame>during time of performing the block</time_frame>
    <description>Number of attempts needed for successful insertion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration needed for insertion</measure>
    <time_frame>during time of performing the block</time_frame>
    <description>Duration needed for successful insertion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Breastcancer</condition>
  <condition>Phyllodes Breast Tumor</condition>
  <arm_group>
    <arm_group_label>Interventional Without Dissectioin</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>confirming insertion of B Braun Catheter Kit Contiplex with 18 Gauge needle using ultrasound without injecting 10 ml of lidocaine 1% as a dissecting solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interventional With Dissectioin</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>confirming insertion of B Braun Catheter Kit Contiplex with 18 Gauge needle using ultrasound after injecting 10 ml of lidocaine 1% as a dissecting solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pectoralis II block &amp; catheter without Lidocaine dissection</intervention_name>
    <description>B Braun Catheter Kit Contiplex with a 18 gauge needle will be used. After topicalization of the skin and sterilization using ultrasound guidance to facilitate performing insertion of the canula. Confirming the tip position will be done by ultrasonography while performing pectoralis type 2 block for cases undergoing simple mastectomy procedures</description>
    <arm_group_label>Interventional Without Dissectioin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pectoralis II block &amp; catheter with Lidocaine dissection</intervention_name>
    <description>B Braun Catheter Kit Contiplex with a 18 gauge needle will be used. After topicalization of the skin and sterilization using ultrasound guidance to facilitate performing insertion of the canula. 10 ml of lidocaine 1% will be injected for plan dissection to facilitate the procedure. Confirming the tip position will be done by ultrasonography while performing pectoralis type 2 block for cases undergoing simple mastectomy procedures</description>
    <arm_group_label>Interventional With Dissectioin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>catheter insertion</intervention_name>
    <description>catheter insertion after Lidocaine dissection</description>
    <arm_group_label>Interventional With Dissectioin</arm_group_label>
    <arm_group_label>Interventional Without Dissectioin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patient scheduled for simple mastectomy&#xD;
&#xD;
          -  Accepted performing the block&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients on anticogulants&#xD;
&#xD;
          -  Chest wall infection&#xD;
&#xD;
          -  Patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Ah Mansour, ass.prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kasr Al Aini Faculty of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kasr Alaini Hospitals</name>
      <address>
        <city>Cairo</city>
        <zip>11553</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/27871558</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>September 7, 2020</last_update_submitted>
  <last_update_submitted_qc>September 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Mohamed Ahmed Mansour</investigator_full_name>
    <investigator_title>assistant professor, anesthesia department, kasr al aini faculty of medicine, cairo university</investigator_title>
  </responsible_party>
  <keyword>pecs block</keyword>
  <keyword>breast surgery</keyword>
  <keyword>ultrasound guidence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</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/NCT03030677
org study id: MMSTD1Pecs2
nct id: NCT03030677
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators are trying to establish an easy technique for insertion of a catheter for
      continuous infusion while performing pectoral type 2 (serratus) block, as a post operative
      pain controlling measure for cases undergoing simple mastectomy, using ultrasound guidence
As the space between the pectoralis minor and the serratus anterior is a fashial plane with a
      connective tissue occupying. we are trying to demonstrate a simple technique for inserting a
      catheter within that fashial plane and making sure of the catheter position, to ensure post
      operative analgesia for cases performing simple mastectomy.

      Now the Pectoralis type 2 block (PECS type 2) is an established technique as regional block
      technique for chest wall procedures.

      We are trying to maximizing the benefit of the block with a catheter insertion to use it for
      continuous infusion of bupivacaine for controlling post operative pain in cases performing
      simple mastectomy procedure
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: successful catheter insertion
time frame: during time of performing the block
description: confirming catheter insertion 5 cm beyond the tip of needle in the proper plan using ultrasound
measure: Number of attempts
time frame: during time of performing the block
description: Number of attempts needed for successful insertion
measure: Duration needed for insertion
time frame: during time of performing the block
description: Duration needed for successful insertion
arm group label: Interventional Without Dissectioin
arm group type: Other
description: confirming insertion of B Braun Catheter Kit Contiplex with 18 Gauge needle using ultrasound without injecting 10 ml of lidocaine 1% as a dissecting solution
arm group label: Interventional With Dissectioin
arm group type: Other
description: confirming insertion of B Braun Catheter Kit Contiplex with 18 Gauge needle using ultrasound after injecting 10 ml of lidocaine 1% as a dissecting solution
intervention type: Procedure
intervention name: Pectoralis II block & catheter without Lidocaine dissection
description: B Braun Catheter Kit Contiplex with a 18 gauge needle will be used. After topicalization of the skin and sterilization using ultrasound guidance to facilitate performing insertion of the canula. Confirming the tip position will be done by ultrasonography while performing pectoralis type 2 block for cases undergoing simple mastectomy procedures
arm group label: Interventional Without Dissectioin
intervention type: Procedure
intervention name: Pectoralis II block & catheter with Lidocaine dissection
description: B Braun Catheter Kit Contiplex with a 18 gauge needle will be used. After topicalization of the skin and sterilization using ultrasound guidance to facilitate performing insertion of the canula. 10 ml of lidocaine 1% will be injected for plan dissection to facilitate the procedure. Confirming the tip position will be done by ultrasonography while performing pectoralis type 2 block for cases undergoing simple mastectomy procedures
arm group label: Interventional With Dissectioin
intervention type: Other
intervention name: catheter insertion
description: catheter insertion after Lidocaine dissection
arm group label: Interventional With Dissectioin
arm group label: Interventional Without Dissectioin
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: No
last name: Mohamed Ah Mansour, ass.prof
role: Principal Investigator
affiliation: Kasr Al Aini Faculty of Medicine
facility: 
country: Egypt
url: http://www.ncbi.nlm.nih.gov/pubmed/27871558
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Mohamed Ahmed Mansour
investigator title: assistant professor, anesthesia department, kasr al aini faculty of medicine, cairo university
mesh term: Breast Neoplasms
mesh term: Lidocaine