<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/NCT03810209</url>
  </required_header>
  <id_info>
    <org_study_id>SAP Block in Mastectomy</org_study_id>
    <nct_id>NCT03810209</nct_id>
  </id_info>
  <brief_title>SAP Block to Reduce Post Mastectomy Pain</brief_title>
  <official_title>Effect of Adding Magnesium Sulphate to Bupivacaine on the Quality of Ultrasound-guided Serratus Plane Block in Patients Undergoing a Modified Radical Mastectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suez Canal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Suez Canal 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>
      To decrease post-operative pain in patients undergoing modified radical mastectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Serratus anterior Plane (SAP) Block has proven to be an effective component of multimodal&#xD;
      analgesic regimens for a variety of thoracic procedures. It is designed to block primarily&#xD;
      the thoracic intercostal nerves and to provide complete analgesia of the lateral part of the&#xD;
      thorax and it may be a viable alternative to paravertebral blockade and thoracic epidural&#xD;
      analgesia and may be associated with fewer side effects. It's straight forward to perform,&#xD;
      with high success rate and minimal incidence of complications.&#xD;
&#xD;
      It was reported prolonged numbness over the area supplied by the lateral cutaneous branches&#xD;
      of the T2-T9 spinal nerves using only 0.4 ml.kg-10.125% levobupivacaine. This is remarkable,&#xD;
      because alternative techniques such as intercostal, interpleural and thoracic paravertebral&#xD;
      block require relatively high concentrations and volumes of local anesthetics to produce&#xD;
      similarly prolonged, multi-dermatomal thoracic analgesia.The duration of Serratus plane block&#xD;
      is limited to the effect of administered local anesthetics (LAs). However, recently adjuvants&#xD;
      such as epinephrine, ketamine and clonidine are added to LA solution in concentrations&#xD;
      advocated for other peripheral blocks to prolong the effect of block with promising results.&#xD;
&#xD;
      Evidence supporting the presence of N-methyl-D-aspartate (NMDA) receptors in skin and muscles&#xD;
      have led to the use of magnesium sulphate (MgSO4) (NMDA antagonist) via different routes for&#xD;
      brachial plexus block and via neuraxial route. Until date, no study has been done to evaluate&#xD;
      the role of MgSO4 as an adjuvant in SAP block. Therefore, the investigators intended this&#xD;
      study to evaluate the role of MgSO4 as an adjuvant to bupivacaine in ultrasound (USG)-guided&#xD;
      SAP block for postoperative analgesia in patients scheduled for modified radical mastectomy.&#xD;
&#xD;
      While the key requirement for successful regional anesthetic blocks is ensuring optimal&#xD;
      distribution of local anesthetic around nerve structures, ultrasound guidance enables the&#xD;
      anesthetist to secure an accurate needle position and to monitor the distribution of the&#xD;
      local anesthetic in real time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">January 9, 2019</completion_date>
  <primary_completion_date type="Actual">December 11, 2018</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The duration of analgesia measured by the time of first analgesic request</measure>
    <time_frame>post operative 24 hours</time_frame>
    <description>magnesium group showed delayed first analgesic request</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Serratus Anterior Plain Block</condition>
  <arm_group>
    <arm_group_label>magnesium sulphate group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The investigator injected 28.5 mL of bupivacaine 0.5% and 1.5 ml MgSo4 (150 mg), a total volume of 30 ml, it was confirmed visually by the ultrasound.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The investigator injected 28.5 mL of Bupivacaine 0.5% and 1.5 mL of normal saline, a total volume of 30 ml, it was confirmed visually by the ultrasound.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium Sulphate</intervention_name>
    <description>adding magnesium sulphate to local anaesthetic in SAP Block</description>
    <arm_group_label>magnesium sulphate group</arm_group_label>
    <other_name>MgSO4</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>adding normal saline to local anaesthetic in SAP block</description>
    <arm_group_label>control group</arm_group_label>
    <other_name>NaCl</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult, female patients, ASA physical status I, II, and III aged older than 18 years&#xD;
             scheduled for modified radical mastectomy surgery under general anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any known allergies to the study drugs. Anatomical abnormalities or infections in the&#xD;
        serratus region. Bleeding disorders e.g. thrombocytopenia, high INR, high PT in chronic&#xD;
        liver or impaired kidney). Patients on chronic pain medications or regularly receiving&#xD;
        analgesics. Pregnant or breast feeding patients. Body Mass Index (BMI) more than 35.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>females with breast cancer for modified radical mastectomy</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>abdelrhman alshawadfy</last_name>
    <role>Principal Investigator</role>
    <affiliation>suez canal univesity</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Suez Canal University</name>
      <address>
        <city>Ismailia</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>April 28, 2020</last_update_submitted>
  <last_update_submitted_qc>April 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Suez Canal University</investigator_affiliation>
    <investigator_full_name>Abdelrhman Alshawadfy</investigator_full_name>
    <investigator_title>clinical professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Sulfate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03810209
org study id: SAP Block in Mastectomy
nct id: NCT03810209
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To decrease post-operative pain in patients undergoing modified radical mastectomy.
The Serratus anterior Plane (SAP) Block has proven to be an effective component of multimodal
      analgesic regimens for a variety of thoracic procedures. It is designed to block primarily
      the thoracic intercostal nerves and to provide complete analgesia of the lateral part of the
      thorax and it may be a viable alternative to paravertebral blockade and thoracic epidural
      analgesia and may be associated with fewer side effects. It's straight forward to perform,
      with high success rate and minimal incidence of complications.

      It was reported prolonged numbness over the area supplied by the lateral cutaneous branches
      of the T2-T9 spinal nerves using only 0.4 ml.kg-10.125% levobupivacaine. This is remarkable,
      because alternative techniques such as intercostal, interpleural and thoracic paravertebral
      block require relatively high concentrations and volumes of local anesthetics to produce
      similarly prolonged, multi-dermatomal thoracic analgesia.The duration of Serratus plane block
      is limited to the effect of administered local anesthetics (LAs). However, recently adjuvants
      such as epinephrine, ketamine and clonidine are added to LA solution in concentrations
      advocated for other peripheral blocks to prolong the effect of block with promising results.

      Evidence supporting the presence of N-methyl-D-aspartate (NMDA) receptors in skin and muscles
      have led to the use of magnesium sulphate (MgSO4) (NMDA antagonist) via different routes for
      brachial plexus block and via neuraxial route. Until date, no study has been done to evaluate
      the role of MgSO4 as an adjuvant in SAP block. Therefore, the investigators intended this
      study to evaluate the role of MgSO4 as an adjuvant to bupivacaine in ultrasound (USG)-guided
      SAP block for postoperative analgesia in patients scheduled for modified radical mastectomy.

      While the key requirement for successful regional anesthetic blocks is ensuring optimal
      distribution of local anesthetic around nerve structures, ultrasound guidance enables the
      anesthetist to secure an accurate needle position and to monitor the distribution of the
      local anesthetic in real time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: The duration of analgesia measured by the time of first analgesic request
time frame: post operative 24 hours
description: magnesium group showed delayed first analgesic request
arm group label: magnesium sulphate group
arm group type: Active Comparator
description: The investigator injected 28.5 mL of bupivacaine 0.5% and 1.5 ml MgSo4 (150 mg), a total volume of 30 ml, it was confirmed visually by the ultrasound.
arm group label: control group
arm group type: Placebo Comparator
description: The investigator injected 28.5 mL of Bupivacaine 0.5% and 1.5 mL of normal saline, a total volume of 30 ml, it was confirmed visually by the ultrasound.
intervention type: Drug
intervention name: Magnesium Sulphate
description: adding magnesium sulphate to local anaesthetic in SAP Block
arm group label: magnesium sulphate group
other name: MgSO4
intervention type: Drug
intervention name: Normal saline
description: adding normal saline to local anaesthetic in SAP block
arm group label: control group
other name: NaCl
criteria: 
gender: Female
gender based: Yes
gender description: females with breast cancer for modified radical mastectomy
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: abdelrhman alshawadfy
role: Principal Investigator
affiliation: suez canal univesity
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Suez Canal University
investigator full name: Abdelrhman Alshawadfy
investigator title: clinical professor
mesh term: Magnesium Sulfate
sharing ipd: No