<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/NCT03790748</url>
  </required_header>
  <id_info>
    <org_study_id>IUD2900</org_study_id>
    <nct_id>NCT03790748</nct_id>
  </id_info>
  <brief_title>Regional Blocks of Gynecological Surgeries</brief_title>
  <official_title>Comparison of Dural Puncture Epidural Technique Versus Conventional Epidural Technique for Adequate Anesthesia During Vaginal Surgeries</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>
      This study will be conducted on 273 patients of ASA grade I and II aged from 25 to 55 years&#xD;
      and presented for elective vaginal surgeries such as vaginal hysterectomy, repair of prolapse&#xD;
      Patients will be divided into three equal groups; group A control group for conventional&#xD;
      epidural technique(n=91), group B for dural puncture epidural with 27G pencil point Whitacre&#xD;
      spinal needle (n=91) and group C for dural puncture epidural with 25G pencil point Whitacre&#xD;
      spinal needle(n=91). Randomization will be done using computer generated number and concealed&#xD;
      using sequentially numbered sealed opaque envelope.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">June 28, 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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of bilateral sacral blockade</measure>
    <time_frame>Up to 30 minutes after local anesthetic injection</time_frame>
    <description>Sensory blockade was evaluated using a non-traumatic pinprick stimulus starting at the S2 dermatome and moving in a caudad direction (measured every 2 minutes)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Onset of sensory blockade</measure>
    <time_frame>Up to 30 minutes after local anesthetic injection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum achieved sensory level</measure>
    <time_frame>Up to 30 minutes after local anesthetic injection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to achieve the maximum sensory level</measure>
    <time_frame>Up to 30 minutes after local anesthetic injection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Onset of motor blockade</measure>
    <time_frame>Up to 30 minutes after local anesthetic injection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to complete motor block</measure>
    <time_frame>Up to 30 minutes after local anesthetic injection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of sensory block</measure>
    <time_frame>Assessed every 20 minutes after achieving highest dermatome level of sensory analgesia</time_frame>
    <description>Time to two segmental dermatomes regression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of motor block</measure>
    <time_frame>Assessed every 20 minutes after achieving Bromage 3 motor block</time_frame>
    <description>Time interval from achievement of Bromage 1 to regression of motor blockade to Bromage 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of analgesia</measure>
    <time_frame>Time for requirement for rescue analgesia or VAS pain score &gt;3 as postoperatively</time_frame>
    <description>Time from onset of sensory block to first complain of pain postoperatively as the epidural catheter will be removed after the surgery finished</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of epidural top-ups</measure>
    <time_frame>Number of extra doses of local anesthetic given after injection of local anesthetic loading dose till end of the surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation score</measure>
    <time_frame>Assessed every 20 minutes during the surgical procedure and postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic parameters</measure>
    <time_frame>Assessed every 5 minutes from the start of anesthetic procedures till transfer the patients to the rooms</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative side effects</measure>
    <time_frame>During surgical period up to 7 days post-operatively</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">273</enrollment>
  <condition>Gynecologic Disease Requiring Vaginal Operation Under Neuraxial Anesthesia</condition>
  <arm_group>
    <arm_group_label>Conventional Epidural Technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Procedure: Standard Lumbar Epidural Block using Touhy Epidural Needle (18G) at L4-5 inter-space and Epidural Catheter (20G) was inserted then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Procedure: 25G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Procedure: 27G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Lumbar Epidural Technique</intervention_name>
    <description>Standard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.</description>
    <arm_group_label>Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle</arm_group_label>
    <arm_group_label>Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>25G Dural Puncture Epidural Technique</intervention_name>
    <description>25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.</description>
    <arm_group_label>Conventional Epidural Technique</arm_group_label>
    <arm_group_label>Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>27G Dural Puncture Epidural Technique</intervention_name>
    <description>27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.</description>
    <arm_group_label>Conventional Epidural Technique</arm_group_label>
    <arm_group_label>Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I and II&#xD;
&#xD;
          -  Height(150-170 cm)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient refusal&#xD;
&#xD;
          -  hypersensitivity to local anesthetic drugs&#xD;
&#xD;
          -  bleeding disorders and coagulopathy(platelets count less than 80000,INR less than 1.5&#xD;
             or therapeutic dose of anticoagulant).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reham Ali Abdelrahman, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesia, Surgical ICU, and Pain Management</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reham Ali Abdelrahman</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>August 27, 2021</last_update_submitted>
  <last_update_submitted_qc>August 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Reham Ali Abdelhaleem Abdelrahman</investigator_full_name>
    <investigator_title>Lecturer of Anesthesia</investigator_title>
  </responsible_party>
  <keyword>Neuraxial Technique, Epidural Technique, Dural Puncture Epidural Technique, Gynecologic Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Genital Diseases, Female</mesh_term>
  </condition_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/NCT03790748
org study id: IUD2900
nct id: NCT03790748
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will be conducted on 273 patients of ASA grade I and II aged from 25 to 55 years
      and presented for elective vaginal surgeries such as vaginal hysterectomy, repair of prolapse
      Patients will be divided into three equal groups; group A control group for conventional
      epidural technique(n=91), group B for dural puncture epidural with 27G pencil point Whitacre
      spinal needle (n=91) and group C for dural puncture epidural with 25G pencil point Whitacre
      spinal needle(n=91). Randomization will be done using computer generated number and concealed
      using sequentially numbered sealed opaque envelope.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: incidence of bilateral sacral blockade
time frame: Up to 30 minutes after local anesthetic injection
description: Sensory blockade was evaluated using a non-traumatic pinprick stimulus starting at the S2 dermatome and moving in a caudad direction (measured every 2 minutes)
measure: Onset of sensory blockade
time frame: Up to 30 minutes after local anesthetic injection
measure: Maximum achieved sensory level
time frame: Up to 30 minutes after local anesthetic injection
measure: Time to achieve the maximum sensory level
time frame: Up to 30 minutes after local anesthetic injection
measure: Onset of motor blockade
time frame: Up to 30 minutes after local anesthetic injection
measure: Time to complete motor block
time frame: Up to 30 minutes after local anesthetic injection
measure: Duration of sensory block
time frame: Assessed every 20 minutes after achieving highest dermatome level of sensory analgesia
description: Time to two segmental dermatomes regression
measure: Duration of motor block
time frame: Assessed every 20 minutes after achieving Bromage 3 motor block
description: Time interval from achievement of Bromage 1 to regression of motor blockade to Bromage 1
measure: Duration of analgesia
time frame: Time for requirement for rescue analgesia or VAS pain score >3 as postoperatively
description: Time from onset of sensory block to first complain of pain postoperatively as the epidural catheter will be removed after the surgery finished
measure: Number of epidural top-ups
time frame: Number of extra doses of local anesthetic given after injection of local anesthetic loading dose till end of the surgery
measure: Sedation score
time frame: Assessed every 20 minutes during the surgical procedure and postoperatively
measure: Hemodynamic parameters
time frame: Assessed every 5 minutes from the start of anesthetic procedures till transfer the patients to the rooms
measure: Perioperative side effects
time frame: During surgical period up to 7 days post-operatively
arm group label: Conventional Epidural Technique
arm group type: Experimental
description: Procedure: Standard Lumbar Epidural Block using Touhy Epidural Needle (18G) at L4-5 inter-space and Epidural Catheter (20G) was inserted then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
arm group label: Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle
arm group type: Active Comparator
description: Procedure: 25G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
arm group label: Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle
arm group type: Active Comparator
description: Procedure: 27G Dural Puncture Epidural Block at L4-5 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
intervention type: Procedure
intervention name: Standard Lumbar Epidural Technique
description: Standard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
arm group label: Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle
arm group label: Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle
intervention type: Procedure
intervention name: 25G Dural Puncture Epidural Technique
description: 25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
arm group label: Conventional Epidural Technique
arm group label: Dural Puncture Epidural Technique using pencil-point 27G Whitacre needle
intervention type: Procedure
intervention name: 27G Dural Puncture Epidural Technique
description: 27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
arm group label: Conventional Epidural Technique
arm group label: Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Reham Ali Abdelrahman, M.D.
role: Principal Investigator
affiliation: Cairo University
facility: 
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Reham Ali Abdelhaleem Abdelrahman
investigator title: Lecturer of Anesthesia
mesh term: Genital Diseases, Female