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/NCT06016205</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-22-07-33</org_study_id>
      <nct_id>NCT06016205</nct_id>
    </id_info>
    <brief_title>The Pectoralis (PECS2) Block Versus Intrathecal Morphine</brief_title>
    <official_title>Ultrasound-guided PECS2 (The Pectoralis) Block Versus Intrathecal Morphine for Postoperative Analgesia After Mastectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag University</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>
        50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of&#xD;
        age scheduled for Modified Radical Mastectomy surgery, Will be included in the study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients will be randomly divided into two groups:&#xD;
  &#xD;
        morphine group (n=25):&#xD;
  &#xD;
        Patients will receive intrathecal 200 microgram morphine immediately before induction of&#xD;
        general anesthesia.&#xD;
  &#xD;
        PECS group (n= 25):&#xD;
  &#xD;
        PECS2 block will be performed and Patients will receive 30 ml bupivacaine 0.25% The drug&#xD;
        solutions will be prepared by an anesthesiologist not involved in the study, the&#xD;
        anesthesiologist performing the block and observing the patients will be blinded to the&#xD;
        treatment group. Data collection will be done by anesthesiologist unaware of the group&#xD;
        allocation.&#xD;
  &#xD;
        In the PECS group patients will be placed in supine position. The block will be performed on&#xD;
        the side of surgery with the ipsilateral upper limb in abduction position. After the skin of&#xD;
        the infraclavicular region disinfected and preparing the US probe and adjusting the depth of&#xD;
        4 to 6cm and gain of Ultrasound machine .The 20-gauge echogenic needle will be introduced&#xD;
        in-plane approach from medial to lateral and 10ml of bupivacaine 0.25% will be injected into&#xD;
        the fascial plane between pectoralis muscles in order to block medial and lateral pectoral&#xD;
        nerve (PECS I). Then the needle will be reinserted into the fascial plane between pectoralis&#xD;
        minor and serratus anterior muscle and 20ml of bupivacaine 0.25%will be injected in&#xD;
        increments of 5 ml after negative aspiration in order to block intercostals II-III-IV-V-VI&#xD;
        and the long thoracic nerve.&#xD;
  &#xD;
        General anesthesia will be induced in all patients with fentanyl (1-2ug/kg), propofol&#xD;
        (1-2mg/kg) and an intuitive dose of atracurium (0. 5mg/kg), endotracheal intubation secured&#xD;
        the airway. Anesthesia will be maintained with isoflurane (1- 2%) and an incremental dose of&#xD;
        atracurium 0.1mg/kg. Controlled ventilation will be accomplished by a ventilator with a tidal&#xD;
        volume of 6-8 ml/kg and an I/E ratio of 1:2 to maintain a tidal carbon dioxide voltage of&#xD;
        approximately 35-40 mmHg.&#xD;
  &#xD;
        The heart rate (HR), noninvasive arterial systolic blood pressure (SBP), diastolic blood&#xD;
        pressure (DBP) and peripheral oxygen saturation (SpO2) will be recorded at baseline, after&#xD;
        induction and with skin incision and every 5 minutes intraoperative till the end of surgery.&#xD;
        And postoperative at 30 min, 1, 2, 3, 6, 12 and 24 hours.&#xD;
  &#xD;
        - Postoperative pain will be assessed using visual analog score (VAS) [0-10]. 0 - 3 mild pain&#xD;
  &#xD;
          -  4 - 6 moderate pain&#xD;
  &#xD;
          -  7 - 10 severe pain&#xD;
  &#xD;
          -  10 &lt;unbearable pain)&#xD;
  &#xD;
        All patients will receive paracetamol (1gm) immediately postoperative and every 6 hours.&#xD;
        Patients will be assessed every one hour in the first 6 hours then every 4 hours in the next&#xD;
        18 hours. Patients will receive ketorolac 30 mg if VAS 3-5. If VAS&gt;5, morphine 0.1mg/kg will&#xD;
        be given then total ketorolac and morphine consumption in 24 hours will be calculated and&#xD;
        compared between both groups.&#xD;
  &#xD;
        Adverse effects will be considered as -bradycardia (if heart rate [HR] is &lt;20% of baseline)&#xD;
        will be treated by atropine (IV) 0.01 mg/kg.&#xD;
  &#xD;
          -  Hypotension (if mean arterial blood pressure is &lt;20% of baseline) will be treated with&#xD;
             (IV) fluid and an incremental (IV) dose of ephedrine 0.2- 0.3 mg/kg or (SC/IM) dose of&#xD;
             ephedrine 0.5 mg/kg.&#xD;
  &#xD;
          -  Respiratory depression, apnea and hypoxemia (spo2 &lt; 92%) will be treated with O2&#xD;
             supplementation.&#xD;
  &#xD;
          -  Also, complications as disturbed conscious level, nausea, vomiting and prolonged motor&#xD;
             block will be recorded.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</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>Health Services Research</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>post-operative analgesia.</measure>
      <time_frame>he visual analog score will be evaluated every 1 hour postoperatively.</time_frame>
      <description>the visual analog score will be evaluated postoperatively in all the patients in both groups</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Post-operative Pain</condition>
    <arm_group>
      <arm_group_label>Morphine group (n= 25):</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>PECS group (n= 25):</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>intrathecal morphine injection</intervention_name>
      <description>Patients will receive intrathecal 200 microgram morphine immediately before induction of general anesthesia</description>
      <arm_group_label>Morphine group (n= 25):</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ultrasound guided PECS2 block</intervention_name>
      <description>ultrasound guided PECS2 block will be performed with 30 ml bupivacaine 0.25%</description>
      <arm_group_label>PECS group (n= 25):</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age&#xD;
               scheduled for Modified Radical Mastectomy surgery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  - Patient refusal.&#xD;
  &#xD;
            -  Patient with significant neurological , psychiatric or neuromuscular disease&#xD;
  &#xD;
            -  Alcoholism. Drug abuse.&#xD;
  &#xD;
            -  Pregnancy or lactating women.&#xD;
  &#xD;
            -  Suspected Coagulopathy.&#xD;
  &#xD;
            -  Morbid obesity.&#xD;
  &#xD;
            -  Known allergy to study medications.&#xD;
  &#xD;
            -  local infection at the block site&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mohammed Ahmed Mahmoud, MD</last_name>
      <phone>01091328413</phone>
      <phone_ext>002</phone_ext>
      <email>mohamedmahmoud@med.sohag.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sohag University</name>
        <address>
          <city>Sohag</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mohammed Ahmed Mahmoud, MD</last_name>
        <phone>01091328413</phone>
        <phone_ext>002</phone_ext>
        <email>mohamedmahmoud@med.sohag.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Mohammed Ahmed Mahmoud</investigator_full_name>
      <investigator_title>Lecturer of anesthesia and ICU</investigator_title>
    </responsible_party>
    <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>Morphine</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06016205
  org study id: Soh-Med-22-07-33
  nct id: NCT06016205
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of
        age scheduled for Modified Radical Mastectomy surgery, Will be included in the study.
  Patients will be randomly divided into two groups:
  
        morphine group (n=25):
  
        Patients will receive intrathecal 200 microgram morphine immediately before induction of
        general anesthesia.
  
        PECS group (n= 25):
  
        PECS2 block will be performed and Patients will receive 30 ml bupivacaine 0.25% The drug
        solutions will be prepared by an anesthesiologist not involved in the study, the
        anesthesiologist performing the block and observing the patients will be blinded to the
        treatment group. Data collection will be done by anesthesiologist unaware of the group
        allocation.
  
        In the PECS group patients will be placed in supine position. The block will be performed on
        the side of surgery with the ipsilateral upper limb in abduction position. After the skin of
        the infraclavicular region disinfected and preparing the US probe and adjusting the depth of
        4 to 6cm and gain of Ultrasound machine .The 20-gauge echogenic needle will be introduced
        in-plane approach from medial to lateral and 10ml of bupivacaine 0.25% will be injected into
        the fascial plane between pectoralis muscles in order to block medial and lateral pectoral
        nerve (PECS I). Then the needle will be reinserted into the fascial plane between pectoralis
        minor and serratus anterior muscle and 20ml of bupivacaine 0.25%will be injected in
        increments of 5 ml after negative aspiration in order to block intercostals II-III-IV-V-VI
        and the long thoracic nerve.
  
        General anesthesia will be induced in all patients with fentanyl (1-2ug/kg), propofol
        (1-2mg/kg) and an intuitive dose of atracurium (0. 5mg/kg), endotracheal intubation secured
        the airway. Anesthesia will be maintained with isoflurane (1- 2%) and an incremental dose of
        atracurium 0.1mg/kg. Controlled ventilation will be accomplished by a ventilator with a tidal
        volume of 6-8 ml/kg and an I/E ratio of 1:2 to maintain a tidal carbon dioxide voltage of
        approximately 35-40 mmHg.
  
        The heart rate (HR), noninvasive arterial systolic blood pressure (SBP), diastolic blood
        pressure (DBP) and peripheral oxygen saturation (SpO2) will be recorded at baseline, after
        induction and with skin incision and every 5 minutes intraoperative till the end of surgery.
        And postoperative at 30 min, 1, 2, 3, 6, 12 and 24 hours.
  
        - Postoperative pain will be assessed using visual analog score (VAS) [0-10]. 0 - 3 mild pain
  
          -  4 - 6 moderate pain
  
          -  7 - 10 severe pain
  
          -  10 <unbearable pain)
  
        All patients will receive paracetamol (1gm) immediately postoperative and every 6 hours.
        Patients will be assessed every one hour in the first 6 hours then every 4 hours in the next
        18 hours. Patients will receive ketorolac 30 mg if VAS 3-5. If VAS>5, morphine 0.1mg/kg will
        be given then total ketorolac and morphine consumption in 24 hours will be calculated and
        compared between both groups.
  
        Adverse effects will be considered as -bradycardia (if heart rate [HR] is <20% of baseline)
        will be treated by atropine (IV) 0.01 mg/kg.
  
          -  Hypotension (if mean arterial blood pressure is <20% of baseline) will be treated with
             (IV) fluid and an incremental (IV) dose of ephedrine 0.2- 0.3 mg/kg or (SC/IM) dose of
             ephedrine 0.5 mg/kg.
  
          -  Respiratory depression, apnea and hypoxemia (spo2 < 92%) will be treated with O2
             supplementation.
  
          -  Also, complications as disturbed conscious level, nausea, vomiting and prolonged motor
             block will be recorded.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Double (Participant, Investigator)
  measure: post-operative analgesia.
  time frame: he visual analog score will be evaluated every 1 hour postoperatively.
  description: the visual analog score will be evaluated postoperatively in all the patients in both groups
  arm group label: Morphine group (n= 25):
  arm group type: Active Comparator
  arm group label: PECS group (n= 25):
  arm group type: Active Comparator
  intervention type: Procedure
  intervention name: intrathecal morphine injection
  description: Patients will receive intrathecal 200 microgram morphine immediately before induction of general anesthesia
  arm group label: Morphine group (n= 25):
  intervention type: Procedure
  intervention name: ultrasound guided PECS2 block
  description: ultrasound guided PECS2 block will be performed with 30 ml bupivacaine 0.25%
  arm group label: PECS group (n= 25):
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mohammed Ahmed Mahmoud, MD
  phone: 01091328413
  phone ext: 002
  email: mohamedmahmoud@med.sohag.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Mohammed Ahmed Mahmoud
  investigator title: Lecturer of anesthesia and ICU
  mesh term: Pain, Postoperative
  mesh term: Morphine