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/NCT06022614</url>
    </required_header>
    <id_info>
      <org_study_id>erector spinae plane block</org_study_id>
      <nct_id>NCT06022614</nct_id>
    </id_info>
    <brief_title>Effect of Adding Dexmedetomidine as Adjuvant to Bupivacaine in US Guided ESPB for Post MRM Pain Management</brief_title>
    <official_title>Effect of Adding Dexmedetomidine as Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Post Modified Radical Mastectomy Pain Management</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the study is to assess the effect of adding dexmedetomidine to bupivacaine in US&#xD;
        guided erector spinae plane block in modified radical mastectomy surgeries , Using visual&#xD;
        analogue score and post-operative narcotics consumption.&#xD;
  &#xD;
        Peripheral nerve blocks are effective adjuvant options for pain management in breast&#xD;
        surgeries. The use of Erector spinae plane block (ESPB) has been proven to be very effective&#xD;
        in controlling pain and minimizing narcotic consumption after modified radical mastectomy&#xD;
        surgeries.&#xD;
  &#xD;
        Many adjuvants to local anaesthetics were used to improve the duration and intensity of the&#xD;
        peripheral nerve block.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Breast cancer is one of the most important medical problems in the female gender, since among&#xD;
        every eight women, one will suffer from breast cancer during her lifetime.&#xD;
  &#xD;
        Acute post-operative pain is very common after breast surgeries which requires adequate pain&#xD;
        management. Different peripheral nerve blocks such as paravertebral block had been used as an&#xD;
        analgesic option for breast surgeries.&#xD;
  &#xD;
        Erector spinae plane block is a newer interfascial plane block first described in 2016 who&#xD;
        used it for treating thoracic neuropathic pain by injecting a local anesthetic deep into the&#xD;
        erector spinae muscle at the level of T5. Moreover, ESPB is a reasonable option, with clearly&#xD;
        identifiable sonographic landmarks and LA needle insertion and injection locations.&#xD;
  &#xD;
        Later studies have shown that ESPB can provide effective analgesia in breast surgeries.&#xD;
  &#xD;
        ESPB is achieved by injecting the local anesthetics locally deep to erector spinae muscle&#xD;
        surface, as a part of multimodal analgesia. Given that erector spinae muscles anatomically&#xD;
        situate along the thoracolumbar spine, ESPB promotes an extensive craniocaudal spread.&#xD;
  &#xD;
        Ultrasound is a non-invasive visualization technology that helps in capturing the anatomical&#xD;
        structure of target tissues, it can help to guide the direction and depth of anesthesia&#xD;
        puncture needles, thus reducing the risk of complications .&#xD;
  &#xD;
        Adjuvants to local anesthetics, such as opioids, alpha 2 agonists, magnesium and&#xD;
        dexamethasone may improve the duration and intensity of peripheral nerve blocks effect.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 1, 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>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The primary outcome will be the first time to request rescue analgesia.</measure>
      <time_frame>From the end of the surgery till 24 hours</time_frame>
      <description>The investigators assess first time to request rescue analgesia according to A) pain score from 0 to 10 while 0 means no pain (best) and 10 means sever pain (worst).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The primary outcome will be the first time to request rescue analgesia</measure>
      <time_frame>From the end of the surgery till 24 hours</time_frame>
      <description>B) patient hemodynamics ex. Heart rate if patient is tachypneic (HR more than 100 beat/min) which is means that the patient is in pain.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Erector Spinae Plane Block</condition>
    <arm_group>
      <arm_group_label>Patients receiving Block with Bupivacaine only</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>consists of patients receiving erector spinae plane block with Bupivacaine only</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients receiving Block using Bupivacaine with Dexmedetomidine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>consists of patients receiving erector spinae plane block using bupivacaine with Dexmedetomidine</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Use Bupivacaine 0.25% Injectable Solution</intervention_name>
      <description>Group A Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml normal saline.</description>
      <arm_group_label>Patients receiving Block with Bupivacaine only</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine</intervention_name>
      <description>Group B Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml dexmedetomidine</description>
      <arm_group_label>Patients receiving Block using Bupivacaine with Dexmedetomidine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age:30-65years.&#xD;
  &#xD;
            -  Physical status: ASA I,II.&#xD;
  &#xD;
            -  BMI&lt;35.&#xD;
  &#xD;
            -  Localized breast cancer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age:&lt;30 and &gt;65 years.&#xD;
  &#xD;
            -  Refusal of procedure or participation in the study by the patient.&#xD;
  &#xD;
            -  Physical status: ASA III or above.&#xD;
  &#xD;
            -  History of allergy to the study drug.&#xD;
  &#xD;
            -  BMI&gt;35.&#xD;
  &#xD;
            -  Bleeding disorders and coagulopathy.&#xD;
  &#xD;
            -  Psychiatric illness that may interfere with the study.&#xD;
  &#xD;
            -  Metastatic breast cancer.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Abanoub Habib, PHD</last_name>
      <phone>01283575659</phone>
      <email>abanoubmoureshabib@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of Medicine Ain Shams University</name>
        <address>
          <city>Cairo</city>
          <zip>1181</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Abanoub Habib, PHD</last_name>
        <phone>01283575659</phone>
        <email>Abanoubmoureshabib@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexmedetomidine</mesh_term>
      <mesh_term>Bupivacaine</mesh_term>
      <mesh_term>Pharmaceutical Solutions</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/NCT06022614
  org study id: erector spinae plane block
  nct id: NCT06022614
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to assess the effect of adding dexmedetomidine to bupivacaine in US
        guided erector spinae plane block in modified radical mastectomy surgeries , Using visual
        analogue score and post-operative narcotics consumption.
  
        Peripheral nerve blocks are effective adjuvant options for pain management in breast
        surgeries. The use of Erector spinae plane block (ESPB) has been proven to be very effective
        in controlling pain and minimizing narcotic consumption after modified radical mastectomy
        surgeries.
  
        Many adjuvants to local anaesthetics were used to improve the duration and intensity of the
        peripheral nerve block.
  Breast cancer is one of the most important medical problems in the female gender, since among
        every eight women, one will suffer from breast cancer during her lifetime.
  
        Acute post-operative pain is very common after breast surgeries which requires adequate pain
        management. Different peripheral nerve blocks such as paravertebral block had been used as an
        analgesic option for breast surgeries.
  
        Erector spinae plane block is a newer interfascial plane block first described in 2016 who
        used it for treating thoracic neuropathic pain by injecting a local anesthetic deep into the
        erector spinae muscle at the level of T5. Moreover, ESPB is a reasonable option, with clearly
        identifiable sonographic landmarks and LA needle insertion and injection locations.
  
        Later studies have shown that ESPB can provide effective analgesia in breast surgeries.
  
        ESPB is achieved by injecting the local anesthetics locally deep to erector spinae muscle
        surface, as a part of multimodal analgesia. Given that erector spinae muscles anatomically
        situate along the thoracolumbar spine, ESPB promotes an extensive craniocaudal spread.
  
        Ultrasound is a non-invasive visualization technology that helps in capturing the anatomical
        structure of target tissues, it can help to guide the direction and depth of anesthesia
        puncture needles, thus reducing the risk of complications .
  
        Adjuvants to local anesthetics, such as opioids, alpha 2 agonists, magnesium and
        dexamethasone may improve the duration and intensity of peripheral nerve blocks effect.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: The primary outcome will be the first time to request rescue analgesia.
  time frame: From the end of the surgery till 24 hours
  description: The investigators assess first time to request rescue analgesia according to A) pain score from 0 to 10 while 0 means no pain (best) and 10 means sever pain (worst).
  measure: The primary outcome will be the first time to request rescue analgesia
  time frame: From the end of the surgery till 24 hours
  description: B) patient hemodynamics ex. Heart rate if patient is tachypneic (HR more than 100 beat/min) which is means that the patient is in pain.
  arm group label: Patients receiving Block with Bupivacaine only
  arm group type: Active Comparator
  description: consists of patients receiving erector spinae plane block with Bupivacaine only
  arm group label: Patients receiving Block using Bupivacaine with Dexmedetomidine
  arm group type: Active Comparator
  description: consists of patients receiving erector spinae plane block using bupivacaine with Dexmedetomidine
  intervention type: Drug
  intervention name: Use Bupivacaine 0.25% Injectable Solution
  description: Group A Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml normal saline.
  arm group label: Patients receiving Block with Bupivacaine only
  intervention type: Drug
  intervention name: Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine
  description: Group B Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml dexmedetomidine
  arm group label: Patients receiving Block using Bupivacaine with Dexmedetomidine
  criteria: 
  gender: Female
  minimum age: 30 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Abanoub Habib, PHD
  phone: 01283575659
  email: abanoubmoureshabib@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Dexmedetomidine
  mesh term: Bupivacaine
  mesh term: Pharmaceutical Solutions