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/NCT05976464</url>
    </required_header>
    <id_info>
      <org_study_id>magnesium analgesic efficacy</org_study_id>
      <nct_id>NCT05976464</nct_id>
    </id_info>
    <brief_title>Efficacy of Magnesium Sulfate as an Adjuvant in Erector Spinae Plane Block as an Anesthetic Post Operative After Modified Radical Mastectomy</brief_title>
    <official_title>Efficacy of Magnesium Sulfate as an Adjuvant to Local Anesthetic in Erector Spinae Plane Block for Post-operative Analgesia After Modified Radical Mastectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut 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>
        efficacy of magnesium sulfate as an adjuvant in erector spinae plane block as an anesthetic&#xD;
        post-operative after modified radical mastectomy&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2023</primary_completion_date>
    <phase>Early Phase 1</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>- The primary outcome measure in this study will be the total dose of morphine consumption during the 24 hour Postoperatively.</measure>
      <time_frame>Up to 24 hour</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>ESPB, Mg Sulfate,Post Mastectomy</condition>
    <arm_group>
      <arm_group_label>erector spinae plane block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Ultrasound-guided Erector spinae plane (ESP) block will be done with the patient in a sitting position depending on the surgical site (lt. or Rt.) ESP block will be given using high-frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to the thoracic third and sixth spinous process, the erector spinae muscle, is identified from the surface, we will deposit 20 ml of 0.25% levobupivacaine into interfacial plane below erector spinae muscle.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>magnesium sulfate as an adjuvant in erector spinae plane block</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Ultrasound-guided Erector spinae plane (ESP) block will be done with the patient in a sitting position depending on surgical site (lt. or Rt.) ESP block will be given using high-frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to the thoracic third and sixth spinous process, the erector spinae muscle, is identified from the surface, we will deposit 20 ml of 0.25% levobupivacaine and magnesium sulfate into interfacial plane below erector spinae muscle.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Magnesium sulfate in erector spinae plane block</intervention_name>
      <description>Ultrasound-guided Erector spinae plane (ESP) block will be done with the patient in a sitting position depending on the surgical site (lt. or Rt.) ESP block will be given using high-frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to the thoracic third and sixth spinous process, the erector spinae muscle, is identified from the surface, we will deposit 20 ml of 0.25% levobupivacaine into interfacial plane below erector spinae muscle.&#xD;
  General anesthesia will be induced with l/kg fentanyl, 2mg/kg propofol, 0.5 mg/kg atracurium and inhalational anesthesia (sevoflurane) No other narcotic, analgesic or sedative will be administrated during the operative period.&#xD;
  BP(SystolicBP, DiastolicBP) and HR will be observed and recorded every 30 min till the end of surgery.</description>
      <arm_group_label>erector spinae plane block</arm_group_label>
      <arm_group_label>magnesium sulfate as an adjuvant in erector spinae plane block</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. ASA I-II. 2. Female patients aged 18-65 years. 3. Scheduled for a modified radical&#xD;
               mastectomy with axillary dissection for breast cancer.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. ASA &lt; II.&#xD;
  &#xD;
            2. more than 65 years old&#xD;
  &#xD;
            3. Patients with known allergies to the study drugs&#xD;
  &#xD;
            4. Skin infection at the site of needle puncture.&#xD;
  &#xD;
            5. Coagulopathy&#xD;
  &#xD;
          5. Drug or as that would interfere with perception and assessment of pain. 6. Uncooperative&#xD;
          patients.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Doha Mohamed Ahmed, MD</investigator_full_name>
      <investigator_title>Principal investigator</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>
    <!-- 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/NCT05976464
  org study id: magnesium analgesic efficacy
  nct id: NCT05976464
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  efficacy of magnesium sulfate as an adjuvant in erector spinae plane block as an anesthetic
        post-operative after modified radical mastectomy
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: - The primary outcome measure in this study will be the total dose of morphine consumption during the 24 hour Postoperatively.
  time frame: Up to 24 hour
  arm group label: erector spinae plane block
  arm group type: Active Comparator
  description: Ultrasound-guided Erector spinae plane (ESP) block will be done with the patient in a sitting position depending on the surgical site (lt. or Rt.) ESP block will be given using high-frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to the thoracic third and sixth spinous process, the erector spinae muscle, is identified from the surface, we will deposit 20 ml of 0.25% levobupivacaine into interfacial plane below erector spinae muscle.
  arm group label: magnesium sulfate as an adjuvant in erector spinae plane block
  arm group type: Experimental
  description: Ultrasound-guided Erector spinae plane (ESP) block will be done with the patient in a sitting position depending on surgical site (lt. or Rt.) ESP block will be given using high-frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to the thoracic third and sixth spinous process, the erector spinae muscle, is identified from the surface, we will deposit 20 ml of 0.25% levobupivacaine and magnesium sulfate into interfacial plane below erector spinae muscle.
  intervention type: Drug
  intervention name: Magnesium sulfate in erector spinae plane block
  description: Ultrasound-guided Erector spinae plane (ESP) block will be done with the patient in a sitting position depending on the surgical site (lt. or Rt.) ESP block will be given using high-frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to the thoracic third and sixth spinous process, the erector spinae muscle, is identified from the surface, we will deposit 20 ml of 0.25% levobupivacaine into interfacial plane below erector spinae muscle.
  General anesthesia will be induced with l/kg fentanyl, 2mg/kg propofol, 0.5 mg/kg atracurium and inhalational anesthesia (sevoflurane) No other narcotic, analgesic or sedative will be administrated during the operative period.
  BP(SystolicBP, DiastolicBP) and HR will be observed and recorded every 30 min till the end of surgery.
  arm group label: erector spinae plane block
  arm group label: magnesium sulfate as an adjuvant in erector spinae plane block
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Doha Mohamed Ahmed, MD
  investigator title: Principal investigator
  mesh term: Magnesium Sulfate