<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/NCT03798834</url>
  </required_header>
  <id_info>
    <org_study_id>R/17.07.111</org_study_id>
    <nct_id>NCT03798834</nct_id>
  </id_info>
  <brief_title>Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy</brief_title>
  <official_title>Fascia Iliaca Block as an Anesthetic Technique for Thromboembolectomy of Chronic Lower Limb Ischemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura 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>
      The fascia iliaca block (FIB) is an anterior approach to block the lumbar plexus. It&#xD;
      disturbed mainly to the anterior region of the thigh by blocking the femoral nerve (LFC) and&#xD;
      the lateral femoral cutaneous nerve. Moreover, FIB may possibly be extended to the obturator,&#xD;
      ilioinguinal, genitofemoral, lateral cutaneous nerve of the thigh and over the psoas muscle&#xD;
      but, rarely reaches the lumbar plexus.&#xD;
&#xD;
      The fascia iliaca compartment could be detected by bony landmarks palpation and the loss of&#xD;
      resistance technique. Feeling two tactile ''pops'' due to loss of resistance occurred during&#xD;
      the needle passage through the fascia lata and the fascia iliaca. Ultrasound (US) guidance of&#xD;
      FIB will increase the success rate and the efficacy of sensory blockade by decreasing the&#xD;
      needed local anesthetic amount.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was conducted to demonstrate the success incidence (to evaluate the efficacy) of&#xD;
      preoperative 0.25% bupivacaine FIB as a sole anesthetic technique in thromboembolectomy of&#xD;
      unilateral chronic lower limb ischemia compared to neuraxial anesthesiaas a primary goal.&#xD;
      Intraoperative hemodynamics variation, postoperative pain score, total analgesic rescue&#xD;
      requests and the total amount of systemic rescue analgesia used in the first postoperative&#xD;
      day in addition to any detected postoperative complications were secondary goals. The&#xD;
      hypothesis is that; FIB will provide adequate anesthesia as neuraxial anesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 17, 2018</start_date>
  <completion_date type="Actual">April 15, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of the patients who did not require conversion to general anesthesia</measure>
    <time_frame>for 30 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>For 24 hours after the intervention</time_frame>
    <description>The post-operative pain will recorded using 10-point Visual Analog Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>For 6 hours after the intervention</time_frame>
    <description>changes in Heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean arterial pressure (MAP</measure>
    <time_frame>For 6 hours after the intervention</time_frame>
    <description>changes in mean arterial pressure (MAP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hypotension</measure>
    <time_frame>For 24 hours from the block</time_frame>
    <description>Incidents of hypotension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any observed adverse effects</measure>
    <time_frame>over the 24 hours postoperative</time_frame>
    <description>ny adverse effects will be observed over the 24 hours postoperative for local skin hematoma ,sensory deficits or local bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bradycardia</measure>
    <time_frame>For 24 hours from the block</time_frame>
    <description>Incidents if bradycardia</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Chronic Lower Limb Ischemia</condition>
  <arm_group>
    <arm_group_label>Fascia iliaca block (FIB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ultrasound-guided Fascia iliaca block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spinal anesthesia</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fascia iliaca block (FIB)</intervention_name>
    <description>ultrasound-guided Fascia iliaca block</description>
    <arm_group_label>Fascia iliaca block (FIB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spinal anesthesia</intervention_name>
    <description>Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%</description>
    <arm_group_label>Spinal anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status I or II.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous same lower limb surgery&#xD;
&#xD;
          -  Neuromuscular disease&#xD;
&#xD;
          -  Severe cardiovascular disease&#xD;
&#xD;
          -  Any contraindications to regional anesthesia&#xD;
&#xD;
          -  patient refusal&#xD;
&#xD;
          -  coagulation abnormality&#xD;
&#xD;
          -  Known allergy to local anesthetics&#xD;
&#xD;
          -  Infection at the injection site&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reem A Elsharkawy, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Lecturer of Anesthesia and Surgical Intensive Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura University</name>
      <address>
        <city>Mansourah</city>
        <state>DK</state>
        <zip>050</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>September 19, 2020</last_update_submitted>
  <last_update_submitted_qc>September 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03798834
org study id: R/17.07.111
nct id: NCT03798834
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The fascia iliaca block (FIB) is an anterior approach to block the lumbar plexus. It
      disturbed mainly to the anterior region of the thigh by blocking the femoral nerve (LFC) and
      the lateral femoral cutaneous nerve. Moreover, FIB may possibly be extended to the obturator,
      ilioinguinal, genitofemoral, lateral cutaneous nerve of the thigh and over the psoas muscle
      but, rarely reaches the lumbar plexus.

      The fascia iliaca compartment could be detected by bony landmarks palpation and the loss of
      resistance technique. Feeling two tactile ''pops'' due to loss of resistance occurred during
      the needle passage through the fascia lata and the fascia iliaca. Ultrasound (US) guidance of
      FIB will increase the success rate and the efficacy of sensory blockade by decreasing the
      needed local anesthetic amount.
This study was conducted to demonstrate the success incidence (to evaluate the efficacy) of
      preoperative 0.25% bupivacaine FIB as a sole anesthetic technique in thromboembolectomy of
      unilateral chronic lower limb ischemia compared to neuraxial anesthesiaas a primary goal.
      Intraoperative hemodynamics variation, postoperative pain score, total analgesic rescue
      requests and the total amount of systemic rescue analgesia used in the first postoperative
      day in addition to any detected postoperative complications were secondary goals. The
      hypothesis is that; FIB will provide adequate anesthesia as neuraxial anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: The proportion of the patients who did not require conversion to general anesthesia
time frame: for 30 minutes
measure: Postoperative pain
time frame: For 24 hours after the intervention
description: The post-operative pain will recorded using 10-point Visual Analog Scale (VAS)
measure: Heart rate
time frame: For 6 hours after the intervention
description: changes in Heart rate
measure: mean arterial pressure (MAP
time frame: For 6 hours after the intervention
description: changes in mean arterial pressure (MAP
measure: hypotension
time frame: For 24 hours from the block
description: Incidents of hypotension
measure: Any observed adverse effects
time frame: over the 24 hours postoperative
description: ny adverse effects will be observed over the 24 hours postoperative for local skin hematoma ,sensory deficits or local bleeding
measure: bradycardia
time frame: For 24 hours from the block
description: Incidents if bradycardia
arm group label: Fascia iliaca block (FIB)
arm group type: Experimental
description: ultrasound-guided Fascia iliaca block
arm group label: Spinal anesthesia
arm group type: Placebo Comparator
description: Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%
intervention type: Drug
intervention name: Fascia iliaca block (FIB)
description: ultrasound-guided Fascia iliaca block
arm group label: Fascia iliaca block (FIB)
intervention type: Other
intervention name: Spinal anesthesia
description: Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%
arm group label: Spinal anesthesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Reem A Elsharkawy, MD
role: Study Chair
affiliation: Lecturer of Anesthesia and Surgical Intensive Care
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Ischemia
mesh term: Anesthetics
sharing ipd: Undecided