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/NCT05971368</url>
    </required_header>
    <id_info>
      <org_study_id>paravertebral vs serratus</org_study_id>
      <nct_id>NCT05971368</nct_id>
    </id_info>
    <brief_title>A Comparative Study Between Ultrasound Guided Thoracic Paravertebral Block VS Serrartus Anterior Muscle Block in VATS as Regard Their Effectiveness in Post-operative Analgesia</brief_title>
    <official_title>A Comparative Study Between Ultrasound Guided Thoracic Paravertebral Block VS Ultrasound Guided Serrartus Anterior Muscle Block in Video-assisted Thoracoscopic Surgeries.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</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>
        A comparative study between ultrasound guided thoracic paravertebral block VS ultrasound&#xD;
        guided serrartus anterior muscle block in video-assisted thoracoscopic surgeries as regard&#xD;
        their effectiveness in post-operative analgesia&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The use of loco-regional analgesia is recommended to control postoperative pain after VATS as&#xD;
        it allows opioid sparing and facilitates early postoperative rehabilitation. Different&#xD;
        loco-regional analgesic techniques could be used to control pain after thoracic surgery such&#xD;
        as a paravertebral block, an intercostal block and serratus plane block. In this study,&#xD;
        Thoracic paravertebral nerve block will be compared to Serratus anterior nerve block, both&#xD;
        will be done Ultrasound guided (USG) using bupivacaine (0.25%) for postoperative analgesia.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 4, 2022</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2, 2023</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>Single (Participant)</masking>
      <masking_description>Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.&#xD;
  Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>total amount of opioid consumption in the two groups according to change in VAS score</measure>
      <time_frame>the first 24 hours postoperatively</time_frame>
      <description>Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3 and another titrating dose (2-3 mg nalbuphine) will be considered if the patient is still complaining in order to reach VAS score ≤ 3 (with maximum dose of 10 mg nalbuphine at a time)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>visual analog scale (VAS)</measure>
      <time_frame>the first 24 hours postoperatively</time_frame>
      <description>Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The onset of 1st analgesic request</measure>
      <time_frame>The first 24 hours postoperatively</time_frame>
      <description>Postoperative pain will be assessed by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3. comparison will be done between the two groups in the onset of 1st analgesic request</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mean arterial blood pressure of the patients</measure>
      <time_frame>first 24 hours postoperatively</time_frame>
      <description>After surgery, Patients will be observed immediately post-operative at 0 (PACU), and 2, 4, 8, 12, 24 hours after surgery for post-operative pain in form of increasing mean arterial blood pressure as a sign of uncontrolled pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>onset of ambulation</measure>
      <time_frame>first 24 hours postoperatively</time_frame>
      <description>controlling pain postoperatively will help in early ambulation which is a major goal post operative to decrease complications</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>complication of nerve block</measure>
      <time_frame>first 24 hours postoperatively</time_frame>
      <description>as hematoma , infection , pneumothorax .</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>heart rate of the patients</measure>
      <time_frame>first 24 hours postoperatively</time_frame>
      <description>After surgery, Patients will be observed immediately post-operative at 0 (PACU), and 2, 4, 8, 12, 24 hours after surgery for post-operative pain in form of increasing heart rate above 90 (pulse per min )as a sign of uncontrolled pain</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Post Operative Pain, Acute</condition>
    <arm_group>
      <arm_group_label>Group A: Patients will receive ultrasound guided thoracic paravertebral block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B: Patients will receive ultrasound guided serratus anterior muscle block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>thoracic paravertebal block</intervention_name>
      <description>o Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.&#xD;
  A high-frequency linear ultrasound probe will be placed between transverse processes from the T4 level (the level of port introduction) in the paramedian plane while patients is in the lateral decubitus position. The transverse processes, superior costotransverse ligaments, and pleura will be well visualized. The block needle (22 gauge) will be advanced until it crosses the superior costotransverse ligament. The prepared 0.25% bupivacaine will be administered at 0.4 mL/kg (max. 40 mL) in the thoracic paravertebral space. Depression of the pleura will be observed as a result of the spread of local anesthetic.</description>
      <arm_group_label>Group A: Patients will receive ultrasound guided thoracic paravertebral block</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>serratus anterior muscle block</intervention_name>
      <description>Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.&#xD;
  While the patient is in the supine position, a high-frequency linear ultrasound probe will be placed horizontally on the mid-axillary line at the level of 4th or 5th ribs on the side of the block. The serratus anterior, latissimus dorsi, and intercostal muscles will be identified. The block needle (22-gauge) will be advanced below the serratus anterior muscle (SAM) towards the fifth rib (using in-plane technique). The prepared 0.25% bupivacaine will be administered at 0.4 mL/kg (max. 40 mL) between the SAM and the rib. It will be observed that the solution of local anesthesia will spread between the SAM and the rib.</description>
      <arm_group_label>Group B: Patients will receive ultrasound guided serratus anterior muscle block</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients American Society of Anesthesiologists physical status (ASA) I to II&#xD;
  &#xD;
            -  Both sexes.&#xD;
  &#xD;
            -  Aged ≥ 20 to ≤ 65years.&#xD;
  &#xD;
            -  Scheduled for VATS under general anesthesia.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient's refusal.&#xD;
  &#xD;
            -  Patients with major spine deformities.&#xD;
  &#xD;
            -  Disruption of the local anatomy, secondary, for instance, to the presence of chest&#xD;
               drains or surgical emphysema, resulting in difficulty in ultrasound interpretation and&#xD;
               distortion of tissue planes.&#xD;
  &#xD;
            -  Patients with bleeding disorders and coagulopathy.&#xD;
  &#xD;
            -  Infection at the injection site.&#xD;
  &#xD;
            -  Known allergy to local anesthetics.&#xD;
  &#xD;
            -  Patients with pre-existing myopathy or neuropathy.&#xD;
  &#xD;
            -  Ipsilateral diaphragmatic paresis.&#xD;
  &#xD;
            -  Tumors in the paravertebral space at the level of injection.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>aya gamal abdelhamid, MSC</last_name>
      <phone>(202) 01067206719</phone>
      <email>ayagamal.3614@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of medicine Ain shams university</name>
        <address>
          <city>Cairo</city>
          <state>Abbasia</state>
          <zip>1181</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>faculty of medicine faculty of medicine ain shams university</last_name>
        <phone>+202-24346344</phone>
        <email>it@med.asu.edu.eg</email>
      </contact>
      <contact_backup>
        <last_name>Research Ethics Committee</last_name>
        <phone>(202)16857539</phone>
        <email>rec-fmasu@med.asu.edu.eg</email>
      </contact_backup>
      <investigator>
        <last_name>AYA GAMAL abdelhamid, master degree</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>regional anesthesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Acute Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05971368
  org study id: paravertebral vs serratus
  nct id: NCT05971368
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  A comparative study between ultrasound guided thoracic paravertebral block VS ultrasound
        guided serrartus anterior muscle block in video-assisted thoracoscopic surgeries as regard
        their effectiveness in post-operative analgesia
  The use of loco-regional analgesia is recommended to control postoperative pain after VATS as
        it allows opioid sparing and facilitates early postoperative rehabilitation. Different
        loco-regional analgesic techniques could be used to control pain after thoracic surgery such
        as a paravertebral block, an intercostal block and serratus plane block. In this study,
        Thoracic paravertebral nerve block will be compared to Serratus anterior nerve block, both
        will be done Ultrasound guided (USG) using bupivacaine (0.25%) for postoperative analgesia.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.
  Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.
  measure: total amount of opioid consumption in the two groups according to change in VAS score
  time frame: the first 24 hours postoperatively
  description: Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3 and another titrating dose (2-3 mg nalbuphine) will be considered if the patient is still complaining in order to reach VAS score ≤ 3 (with maximum dose of 10 mg nalbuphine at a time)
  measure: visual analog scale (VAS)
  time frame: the first 24 hours postoperatively
  description: Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3
  measure: The onset of 1st analgesic request
  time frame: The first 24 hours postoperatively
  description: Postoperative pain will be assessed by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3. comparison will be done between the two groups in the onset of 1st analgesic request
  measure: mean arterial blood pressure of the patients
  time frame: first 24 hours postoperatively
  description: After surgery, Patients will be observed immediately post-operative at 0 (PACU), and 2, 4, 8, 12, 24 hours after surgery for post-operative pain in form of increasing mean arterial blood pressure as a sign of uncontrolled pain
  measure: onset of ambulation
  time frame: first 24 hours postoperatively
  description: controlling pain postoperatively will help in early ambulation which is a major goal post operative to decrease complications
  measure: complication of nerve block
  time frame: first 24 hours postoperatively
  description: as hematoma , infection , pneumothorax .
  measure: heart rate of the patients
  time frame: first 24 hours postoperatively
  description: After surgery, Patients will be observed immediately post-operative at 0 (PACU), and 2, 4, 8, 12, 24 hours after surgery for post-operative pain in form of increasing heart rate above 90 (pulse per min )as a sign of uncontrolled pain
  arm group label: Group A: Patients will receive ultrasound guided thoracic paravertebral block
  arm group type: Active Comparator
  description: Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.
  arm group label: Group B: Patients will receive ultrasound guided serratus anterior muscle block
  arm group type: Active Comparator
  description: Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.
  intervention type: Procedure
  intervention name: thoracic paravertebal block
  description: o Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.
  A high-frequency linear ultrasound probe will be placed between transverse processes from the T4 level (the level of port introduction) in the paramedian plane while patients is in the lateral decubitus position. The transverse processes, superior costotransverse ligaments, and pleura will be well visualized. The block needle (22 gauge) will be advanced until it crosses the superior costotransverse ligament. The prepared 0.25% bupivacaine will be administered at 0.4 mL/kg (max. 40 mL) in the thoracic paravertebral space. Depression of the pleura will be observed as a result of the spread of local anesthetic.
  arm group label: Group A: Patients will receive ultrasound guided thoracic paravertebral block
  intervention type: Procedure
  intervention name: serratus anterior muscle block
  description: Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.
  While the patient is in the supine position, a high-frequency linear ultrasound probe will be placed horizontally on the mid-axillary line at the level of 4th or 5th ribs on the side of the block. The serratus anterior, latissimus dorsi, and intercostal muscles will be identified. The block needle (22-gauge) will be advanced below the serratus anterior muscle (SAM) towards the fifth rib (using in-plane technique). The prepared 0.25% bupivacaine will be administered at 0.4 mL/kg (max. 40 mL) between the SAM and the rib. It will be observed that the solution of local anesthesia will spread between the SAM and the rib.
  arm group label: Group B: Patients will receive ultrasound guided serratus anterior muscle block
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: aya gamal abdelhamid, MSC
  phone: (202) 01067206719
  email: ayagamal.3614@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Pain, Postoperative
  mesh term: Acute Pain
  sharing ipd: Undecided