<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/NCT03023982</url>
  </required_header>
  <id_info>
    <org_study_id>SOR 34516 CTIL</org_study_id>
    <nct_id>NCT03023982</nct_id>
  </id_info>
  <brief_title>Pectoralis and Serratus Nerves Block in Thoracic Surgery</brief_title>
  <official_title>Ultrasound Guided PECs II (Pectoralis and Serratus Nerves) Block in Patients Undergoing a Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soroka University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soroka University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A new conceptual regional anesthesia the PECs II block (modified pectoral and serratus nerves&#xD;
      block) has been described for pain control after thoracic surgery, one of the indications to&#xD;
      perform this method is analgesia for surgeries or procedures involving lateral chest wall&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The PECs I block was found to be very effective after breast cancer surgery and sub-pectoral&#xD;
      prosthesis for pain control management.&#xD;
&#xD;
      This block is provided by injection into another myofascial plane, this time between&#xD;
      pectoralis minor and serratus anterior muscle at the level of 3rd and 4th rib.PECs II block&#xD;
      is simple in performance with a high success rate and minimal incidence of complications,&#xD;
      especially, if used ultrasound approach that gives a good understanding of anatomy of the&#xD;
      lateral thoracic wall.&#xD;
&#xD;
      In present clinical trial we are going to compare PECs block for pain control with&#xD;
      traditional pain management techniques based on IV opioids and NSAIDs treatment in patient&#xD;
      undergoing thoracic surgery in early postoperative period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">February 2019</primary_completion_date>
  <phase>Phase 2</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison Visual Analog Score between groups</measure>
    <time_frame>First 24 hours from the surgery</time_frame>
    <description>First VAS after admission in PACU</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total NSAIDs dosage (mg) in the PACU and department</measure>
    <time_frame>First 24 hours from the surgery</time_frame>
    <description>While the patient is in PACU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>up to 21 days</time_frame>
    <description>Measuring time of at discharge from hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total morphine dosage (mg) in the PACU and department</measure>
    <time_frame>First 24 hours from the surgery</time_frame>
    <description>While the patient is in PACU</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">168</enrollment>
  <condition>Anesthesia</condition>
  <condition>Surgery</condition>
  <condition>Block</condition>
  <condition>Thoracic Injury</condition>
  <arm_group>
    <arm_group_label>Pectoralic block group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After general anesthesia, 40ml of 0.25% Bupivacaine Hydrochloride will be administered before procedure Thoracotomy. Block will be administrated between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib., in assistance of ultrasound for visualization anesthetic injection point.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will receive standard pain control with opioids and NSAIDs</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine Hydrochloride</intervention_name>
    <description>40 cc 0.25% of Bupivacaine Hydrochloride injection using ultrasound approach will be administered between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib</description>
    <arm_group_label>Pectoralic block group</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>All blocks will be done under ultrasound</description>
    <arm_group_label>Pectoralic block group</arm_group_label>
    <other_name>Sonosite</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thoracotomy</intervention_name>
    <description>The patient population will include patients that undergo either open thoracotomy or thoracoscopy for anatomic and non-anatomic lung resection. The standard thoracoscopy approach in our institute includes three holes technic. There are two incisions of 1 cm and utility incision of 4 cm. The standard thoracotomy is posterior- lateral thoracotomy which divided the latissimus dorsi muscle but spears the serratus anterior muscle.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Pectoralic block group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Opioids</intervention_name>
    <description>standard pain control with opioids</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Pectoralic block group</arm_group_label>
    <other_name>Morphine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NSAID</intervention_name>
    <description>standard pain control with NSAIDs</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Pectoralic block group</arm_group_label>
    <other_name>Perfalgan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients undergoing thoracic surgery, older ≥18 years&#xD;
&#xD;
          2. Patients who meet criteria of ASA I-II-III class.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who will be unconscious or mentally incompetent&#xD;
&#xD;
          2. Patients refusal to participate in the study&#xD;
&#xD;
          3. ASA -IV -V&#xD;
&#xD;
          4. Patient with coagulopathy&#xD;
&#xD;
          5. Hemodynamically unstable (systolic BP &lt; 90, HR &gt; 100)&#xD;
&#xD;
          6. Allergy to local anesthetic drugs or opioids&#xD;
&#xD;
          7. Pregnant patient&#xD;
&#xD;
          8. History of opioid abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 17, 2017</last_update_submitted>
  <last_update_submitted_qc>January 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Soroka University Medical Center</investigator_affiliation>
    <investigator_full_name>Semionov Michael</investigator_full_name>
    <investigator_title>Primary Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thoracic Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>will be decided later</ipd_description>
  </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/NCT03023982
org study id: SOR 34516 CTIL
nct id: NCT03023982
lead sponsor: 
has dmc: Yes
A new conceptual regional anesthesia the PECs II block (modified pectoral and serratus nerves
      block) has been described for pain control after thoracic surgery, one of the indications to
      perform this method is analgesia for surgeries or procedures involving lateral chest wall
The PECs I block was found to be very effective after breast cancer surgery and sub-pectoral
      prosthesis for pain control management.

      This block is provided by injection into another myofascial plane, this time between
      pectoralis minor and serratus anterior muscle at the level of 3rd and 4th rib.PECs II block
      is simple in performance with a high success rate and minimal incidence of complications,
      especially, if used ultrasound approach that gives a good understanding of anatomy of the
      lateral thoracic wall.

      In present clinical trial we are going to compare PECs block for pain control with
      traditional pain management techniques based on IV opioids and NSAIDs treatment in patient
      undergoing thoracic surgery in early postoperative period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Comparison Visual Analog Score between groups
time frame: First 24 hours from the surgery
description: First VAS after admission in PACU
measure: Total NSAIDs dosage (mg) in the PACU and department
time frame: First 24 hours from the surgery
description: While the patient is in PACU
measure: Length of hospital stay
time frame: up to 21 days
description: Measuring time of at discharge from hospital
measure: Total morphine dosage (mg) in the PACU and department
time frame: First 24 hours from the surgery
description: While the patient is in PACU
arm group label: Pectoralic block group
arm group type: Experimental
description: After general anesthesia, 40ml of 0.25% Bupivacaine Hydrochloride will be administered before procedure Thoracotomy. Block will be administrated between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib., in assistance of ultrasound for visualization anesthetic injection point.
arm group label: Control group
arm group type: Active Comparator
description: Patients in this group will receive standard pain control with opioids and NSAIDs
intervention type: Drug
intervention name: Bupivacaine Hydrochloride
description: 40 cc 0.25% of Bupivacaine Hydrochloride injection using ultrasound approach will be administered between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib
arm group label: Pectoralic block group
other name: Marcaine
intervention type: Device
intervention name: Ultrasound
description: All blocks will be done under ultrasound
arm group label: Pectoralic block group
other name: Sonosite
intervention type: Procedure
intervention name: Thoracotomy
description: The patient population will include patients that undergo either open thoracotomy or thoracoscopy for anatomic and non-anatomic lung resection. The standard thoracoscopy approach in our institute includes three holes technic. There are two incisions of 1 cm and utility incision of 4 cm. The standard thoracotomy is posterior- lateral thoracotomy which divided the latissimus dorsi muscle but spears the serratus anterior muscle.
arm group label: Control group
arm group label: Pectoralic block group
intervention type: Drug
intervention name: Opioids
description: standard pain control with opioids
arm group label: Control group
arm group label: Pectoralic block group
other name: Morphine
intervention type: Drug
intervention name: NSAID
description: standard pain control with NSAIDs
arm group label: Control group
arm group label: Pectoralic block group
other name: Perfalgan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Soroka University Medical Center
investigator full name: Semionov Michael
investigator title: Primary Investigator
mesh term: Thoracic Injuries
mesh term: Morphine
mesh term: Bupivacaine
sharing ipd: Undecided
ipd description: will be decided later