<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/NCT04498351</url>
  </required_header>
  <id_info>
    <org_study_id>N-19-2020</org_study_id>
    <nct_id>NCT04498351</nct_id>
  </id_info>
  <brief_title>Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine</brief_title>
  <official_title>Evaluation of Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine for Augmenting Analgesia and Anesthesia in Ultrasound Guided Spermatic Cord Block For Testicular Sperm Extraction Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Using the spermatic cord block has been of great advantage, as it has been cost saving,&#xD;
      efficient technique whether used inon its own or combination with a sedative or .&#xD;
      Furthermore, it provides minimal cardiac risks, early case ambulation, satisfactory&#xD;
      postoperative pain control, as well as a reduced hospital stay and cost. one of the major&#xD;
      drawbacks of spermatic cord block is being a single injection technique, leading to a short&#xD;
      postoperative analgesia duration. So, to overcome this flaw some adjuvants were proven to&#xD;
      prolong the analgesia duration as Dexmetedomidine (Dex), and magnesium.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The technique of the spermatic cord block was first described in the 1960s by Earle AS.Using&#xD;
      the spermatic cord block has been of great advantage, as it has been cost saving, efficient&#xD;
      technique whether used inon its own or combination with a sedative or . Furthermore, it&#xD;
      provides minimal cardiac risks, early case ambulation, satisfactory postoperative pain&#xD;
      control, as well as a reduced hospital stay and cost. one of the major drawbacks of spermatic&#xD;
      cord block is being a single injection technique, leading to a short postoperative analgesia&#xD;
      duration. So, to overcome this flaw some adjuvants were proven to prolong the analgesia&#xD;
      duration as Dexmetedomidine (Dex), and magnesium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">October 22, 2021</completion_date>
  <primary_completion_date type="Actual">September 20, 2021</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>
    <intervention_model_description>Following skin sterilization and local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle is inserted in-plane to the ultrasound beam in a cranial-to-caudal direction the spermatic cord in short axis and directed towards the deferent duct, contralateral to the testicular artery. The needle tip was advanced to become contact with the deferent. Correct location of the needle tip was confirmed by injecting 0.5-1 ml to see the local anesthetic spreading around the deferent duct. A total of 18ml levobupivacaine 0.5% are then injected into the spermatic cord block .&#xD;
The procedure is repeated on the contralateral side.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Prospective randomized double blinded clinical study on humans</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Time from injection of LA to the first postoperative analgesic request</measure>
    <time_frame>UP TO 1 HOURE</time_frame>
    <description>(duration of the block).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>beat/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>0 No Pain 1-3 Mild Pain (nagging, annoying, interfering little with ADLs) 4-6 Moderate Pain (interferes significantly with ADLs) 7-10 Severe Pain (disabling; unable to perform ADLs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>perform SCAB</measure>
    <time_frame>UP TO 1 HOURE</time_frame>
    <description>The mean time needed to perform SCAB</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total nalbuphine consumption</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>total nalbuphine consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of complications</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean arterial blood pressure</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>mmHg</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Spermatic Cord Block</condition>
  <arm_group>
    <arm_group_label>cotrol group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>dexmedetomidine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>magnesium sulphate group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>dexmedetomidine and magnesium sulphate group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Control Test</intervention_name>
    <description>Spermatic cord block by18ml levobupivacaine 0.5% plus 2 ml normal saline in total volume of 20 ml.&#xD;
The procedure is repeated on the contralateral side.</description>
    <arm_group_label>cotrol group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 1 μg/kg dexmedetomidine in 2 ml in total volume of 20 ml The procedure is repeated on the contralateral side.</description>
    <arm_group_label>dexmedetomidine group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine and magnesium sulphate</intervention_name>
    <description>Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 1 μg/kg dexmedetomidine and 100 mg magnesium sulphate in 2 ml in total volume of 20 ml .&#xD;
The procedure is repeated on the contralateral side.</description>
    <arm_group_label>dexmedetomidine and magnesium sulphate group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>magnesium sulphate</intervention_name>
    <description>Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 100 mg magnesium sulphate in 2 ml in total volume of 20 ml</description>
    <arm_group_label>magnesium sulphate group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged from 18 to 60 years.&#xD;
&#xD;
          -  ASA I-II.&#xD;
&#xD;
          -  Undergoing Testicular Sperm Extraction Surgery.&#xD;
&#xD;
          -  BMI from 18.5 to 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Contraindications to regional anesthesia (bleeding disorders e.g. INR&gt;1.5, PC&lt;70%,&#xD;
             platelet count&lt;100 × 109, use of any anti-coagulants, local infection, etc.).&#xD;
&#xD;
          -  Known allergy to local anesthetics.&#xD;
&#xD;
          -  ASA III-IV.&#xD;
&#xD;
          -  Patients aged less than 18 or more than 60.&#xD;
&#xD;
          -  Body mass index &gt;35.&#xD;
&#xD;
          -  Patients with difficulty in evaluating their level of pain.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>the operation only in male</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>mohamad abdulfatah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>lecture</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine, Cairo University.</name>
      <address>
        <city>Cairo</city>
        <zip>11451</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>March 19, 2022</last_update_submitted>
  <last_update_submitted_qc>March 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Amr Samir Wahdan</investigator_full_name>
    <investigator_title>Lecturer of Anesthesia, Pain management and Surgical ICU</investigator_title>
  </responsible_party>
  <keyword>Spermatic Cord Block</keyword>
  <keyword>Magnesium Sulfate</keyword>
  <keyword>Dexmedetomidine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Sulfate</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>still working</ipd_description>
  </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/NCT04498351
org study id: N-19-2020
nct id: NCT04498351
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Using the spermatic cord block has been of great advantage, as it has been cost saving,
      efficient technique whether used inon its own or combination with a sedative or .
      Furthermore, it provides minimal cardiac risks, early case ambulation, satisfactory
      postoperative pain control, as well as a reduced hospital stay and cost. one of the major
      drawbacks of spermatic cord block is being a single injection technique, leading to a short
      postoperative analgesia duration. So, to overcome this flaw some adjuvants were proven to
      prolong the analgesia duration as Dexmetedomidine (Dex), and magnesium.
The technique of the spermatic cord block was first described in the 1960s by Earle AS.Using
      the spermatic cord block has been of great advantage, as it has been cost saving, efficient
      technique whether used inon its own or combination with a sedative or . Furthermore, it
      provides minimal cardiac risks, early case ambulation, satisfactory postoperative pain
      control, as well as a reduced hospital stay and cost. one of the major drawbacks of spermatic
      cord block is being a single injection technique, leading to a short postoperative analgesia
      duration. So, to overcome this flaw some adjuvants were proven to prolong the analgesia
      duration as Dexmetedomidine (Dex), and magnesium.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Following skin sterilization and local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle is inserted in-plane to the ultrasound beam in a cranial-to-caudal direction the spermatic cord in short axis and directed towards the deferent duct, contralateral to the testicular artery. The needle tip was advanced to become contact with the deferent. Correct location of the needle tip was confirmed by injecting 0.5-1 ml to see the local anesthetic spreading around the deferent duct. A total of 18ml levobupivacaine 0.5% are then injected into the spermatic cord block .
The procedure is repeated on the contralateral side.
primary purpose: Diagnostic
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Prospective randomized double blinded clinical study on humans
measure: Time from injection of LA to the first postoperative analgesic request
time frame: UP TO 1 HOURE
description: (duration of the block).
measure: heart rate
time frame: up to 24 hours
description: beat/min
measure: VAS
time frame: up to 24 hours
description: 0 No Pain 1-3 Mild Pain (nagging, annoying, interfering little with ADLs) 4-6 Moderate Pain (interferes significantly with ADLs) 7-10 Severe Pain (disabling; unable to perform ADLs)
measure: perform SCAB
time frame: UP TO 1 HOURE
description: The mean time needed to perform SCAB
measure: total nalbuphine consumption
time frame: up to 24 hours
description: total nalbuphine consumption
measure: Incidence of complications
time frame: up to 24 hours
description: complications
measure: mean arterial blood pressure
time frame: up to 24 hours
description: mmHg
arm group label: cotrol group
arm group type: Placebo Comparator
arm group label: dexmedetomidine group
arm group type: Active Comparator
arm group label: magnesium sulphate group
arm group type: Active Comparator
arm group label: dexmedetomidine and magnesium sulphate group
arm group type: Active Comparator
intervention type: Drug
intervention name: Control Test
description: Spermatic cord block by18ml levobupivacaine 0.5% plus 2 ml normal saline in total volume of 20 ml.
The procedure is repeated on the contralateral side.
arm group label: cotrol group
intervention type: Drug
intervention name: Dexmedetomidine
description: Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 1 μg/kg dexmedetomidine in 2 ml in total volume of 20 ml The procedure is repeated on the contralateral side.
arm group label: dexmedetomidine group
intervention type: Drug
intervention name: Dexmedetomidine and magnesium sulphate
description: Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 1 μg/kg dexmedetomidine and 100 mg magnesium sulphate in 2 ml in total volume of 20 ml .
The procedure is repeated on the contralateral side.
arm group label: dexmedetomidine and magnesium sulphate group
intervention type: Drug
intervention name: magnesium sulphate
description: Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 100 mg magnesium sulphate in 2 ml in total volume of 20 ml
arm group label: magnesium sulphate group
criteria: 
gender: Male
gender based: Yes
gender description: the operation only in male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: mohamad abdulfatah, MD
role: Principal Investigator
affiliation: lecture
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Amr Samir Wahdan
investigator title: Lecturer of Anesthesia, Pain management and Surgical ICU
mesh term: Magnesium Sulfate
mesh term: Dexmedetomidine
sharing ipd: Undecided
ipd description: still working