<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/NCT04492319</url>
  </required_header>
  <id_info>
    <org_study_id>N-18-2020</org_study_id>
    <nct_id>NCT04492319</nct_id>
  </id_info>
  <brief_title>Addition of Neostigmine to Levobupivacaine</brief_title>
  <official_title>The Effect of Addition of Neostigmine to Levobupivacaine in Male Patients Receiving Ultrasound Guided Spermatic Cord Block for Postoperative Analgesia in 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 neostigmine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Anticipated">October 20, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 23, 2021</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time from injection of Local anaesthesia to the first postoperative analgesic request</measure>
    <time_frame>UP TO 24 HOURE</time_frame>
    <description>(duration of the block).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>visual analog scale</measure>
    <time_frame>UP TO 24 HOURE</time_frame>
    <description>visual analog scale ; 0 is bad / 10: is good</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>spermatic cord block time</measure>
    <time_frame>UP TO 1 HOURE</time_frame>
    <description>The mean time needed to perform spermatic cord block</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 HOURE</time_frame>
    <description>mean arterial blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>heart rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">112</enrollment>
  <condition>Spermatic Cord Block</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>neostigmine 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 by 9.5 ml Levobupivacaine 0.5% plus 0.5 ml 0.9 normal saline in each side</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neostigmine</intervention_name>
    <description>spermatic cord block by 9,5 ml Levobupivacaine 0.5% plus neostigmine 250 μg in each side .</description>
    <arm_group_label>neostigmine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged from 20 to 45 years.&#xD;
&#xD;
          -  American Society of Anesthesiologists I-II.&#xD;
&#xD;
          -  Undergoing Testicular Sperm Extraction Surgery.&#xD;
&#xD;
          -  BMI from 18.5 to 40 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Contraindications to regional anesthesia (bleeding disorders e.g. international&#xD;
             normalized ratio &gt;1.5, Prothrombin Concentration &lt;70%, platelet count&lt;100 × 109, use&#xD;
             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;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>operation in male only</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amr wahdan</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>December 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>December 23, 2020</last_update_submitted>
  <last_update_submitted_qc>December 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2020</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>Neostigmine</keyword>
  <keyword>Levobupivacaine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neostigmine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>sill 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/NCT04492319
org study id: N-18-2020
nct id: NCT04492319
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 neostigmine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time from injection of Local anaesthesia to the first postoperative analgesic request
time frame: UP TO 24 HOURE
description: (duration of the block).
measure: visual analog scale
time frame: UP TO 24 HOURE
description: visual analog scale ; 0 is bad / 10: is good
measure: spermatic cord block time
time frame: UP TO 1 HOURE
description: The mean time needed to perform spermatic cord block
measure: Incidence of complications
time frame: up to 24 hours
description: complications
measure: mean arterial blood pressure
time frame: UP TO 24 HOURE
description: mean arterial blood pressure
measure: heart rate
time frame: up to 24 hours
description: heart rate
arm group label: control group
arm group type: Active Comparator
arm group label: neostigmine group
arm group type: Active Comparator
intervention type: Drug
intervention name: Control Test
description: spermatic cord block by 9.5 ml Levobupivacaine 0.5% plus 0.5 ml 0.9 normal saline in each side
arm group label: control group
intervention type: Drug
intervention name: Neostigmine
description: spermatic cord block by 9,5 ml Levobupivacaine 0.5% plus neostigmine 250 μg in each side .
arm group label: neostigmine group
criteria: 
gender: Male
gender based: Yes
gender description: operation in male only
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amr wahdan
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: Neostigmine
sharing ipd: Undecided
ipd description: sill working