<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/NCT04429893</url>
  </required_header>
  <id_info>
    <org_study_id>0304543</org_study_id>
    <nct_id>NCT04429893</nct_id>
  </id_info>
  <brief_title>Magnesium Sulphate to Bupivicaine in Serratus Anterior Plane Block in Modified Radical Mastectomy</brief_title>
  <official_title>Effectiveness of Adding Magnesium Sulphate to Bupivicaine in Ultrasound Guided Serratus Anterior Plane Block in Patients Undergoing Modified Radical Mastectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Modified radical mastectomy may be associated with severe post-operative pain, leading to&#xD;
      chronic pain syndrome which usually requires optimal perioperative pain management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomly into two equal groups (40 patients each) according to the adjuvant&#xD;
      added to the local anesthetic (bupivacaine) in the serratus anterior plane block using a&#xD;
      computer-generated random numbers concealed in sealed opaque envelopes. Group B: The patients&#xD;
      will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml.&#xD;
      Group BM: The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate&#xD;
      in 0.9% normal saline with a total volume of 25 ml.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2022</start_date>
  <completion_date type="Anticipated">September 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2022</primary_completion_date>
  <phase>Phase 2/Phase 3</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>assessment of the pain intensity</measure>
    <time_frame>24 hours</time_frame>
    <description>Pain assessment by visual analogue scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Cancer Breast</condition>
  <condition>Chronic Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Group BM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>magnesium sulphate</intervention_name>
    <description>assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy</description>
    <arm_group_label>Group BM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bupivicaine</intervention_name>
    <description>assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy</description>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group BM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult female patients&#xD;
&#xD;
          -  American Society Of Anesthesiologists (ASA) class I or II&#xD;
&#xD;
          -  scheduled for elective unilateral modified radical mastectomy&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  patient refusal&#xD;
&#xD;
          -  bilateral breast surgery&#xD;
&#xD;
          -  coagulation disorders&#xD;
&#xD;
          -  body mass index&gt; 35&#xD;
&#xD;
          -  allergy to local anaesthetics or magnesium sulphate&#xD;
&#xD;
          -  severe respiratory or cardiac disorders&#xD;
&#xD;
          -  pre-existing neurological deficits&#xD;
&#xD;
          -  liver or renal insufficiency&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rehab A. Abd Elaziz, Ass.Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rehab A. Abd Elaziz, Ass. Prof.</last_name>
    <phone>01001073703</phone>
    <phone_ext>020</phone_ext>
    <email>trcium2002@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rehab Abd Elraof Abd Elaziz</name>
      <address>
        <city>Alexandria</city>
        <state>Smouha</state>
        <zip>000000</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rehab A. Abd Elaziz, Ass. Prof.</last_name>
      <phone>01001073703</phone>
      <phone_ext>020</phone_ext>
      <email>trcium2002@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>July 31, 2022</last_update_submitted>
  <last_update_submitted_qc>July 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>rehab zayed</investigator_full_name>
    <investigator_title>Assisstant Professor of Anesthesia</investigator_title>
  </responsible_party>
  <keyword>serratus anterior plane block</keyword>
  <keyword>magnesium sulphate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Sulfate</mesh_term>
    <mesh_term>Bupivacaine</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/NCT04429893
org study id: 0304543
nct id: NCT04429893
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Modified radical mastectomy may be associated with severe post-operative pain, leading to
      chronic pain syndrome which usually requires optimal perioperative pain management.
Patients will be randomly into two equal groups (40 patients each) according to the adjuvant
      added to the local anesthetic (bupivacaine) in the serratus anterior plane block using a
      computer-generated random numbers concealed in sealed opaque envelopes. Group B: The patients
      will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml.
      Group BM: The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate
      in 0.9% normal saline with a total volume of 25 ml.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: assessment of the pain intensity
time frame: 24 hours
description: Pain assessment by visual analogue scale
arm group label: Group BM
arm group type: Experimental
description: The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.
arm group label: Group B
arm group type: Active Comparator
description: The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml
intervention type: Drug
intervention name: magnesium sulphate
description: assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy
arm group label: Group BM
intervention type: Drug
intervention name: bupivicaine
description: assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy
arm group label: Group B
arm group label: Group BM
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Rehab A. Abd Elaziz, Ass.Prof.
role: Principal Investigator
affiliation: Alexandria University
last name: Rehab A. Abd Elaziz, Ass. Prof.
phone: 01001073703
phone ext: 020
email: trcium2002@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: rehab zayed
investigator title: Assisstant Professor of Anesthesia
mesh term: Chronic Pain
mesh term: Magnesium Sulfate
mesh term: Bupivacaine