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/NCT06019754</url>
    </required_header>
    <id_info>
      <org_study_id>IRB#10892</org_study_id>
      <nct_id>NCT06019754</nct_id>
    </id_info>
    <brief_title>The Anterior Approach of the Combined Lumbar and Sacral Plexuses Block for Analgesia of Lower Limb Surgeries</brief_title>
    <official_title>The One-Point Puncture Anterior Approach of the Combined Lumbar and Sacral Plexuses Block for Analgesia of Lower Limb Orthopedic Surgeries</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zagazig University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zagazig University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        lumbosacral plexus block (LSPB) has been widely applied in orthopedics departments due to its&#xD;
        advantages, including reduction in the application of opiates, decreasing the occurrence of&#xD;
        acute pain, promoting early activation, and shortening the time of hospital stay. LSPB is a&#xD;
        peripheral regional technique of anesthesia and analgesia, that provides a block of the main&#xD;
        components of the lumbosacral plexus.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Traditional ultrasound-guided lumbar plexus block combined with sacral plexus block requires&#xD;
        separate blocks at different sites, requiring the lateral decubitus or prone position, which&#xD;
        may be suboptimal in patients with severe pain. we present an anterior approach for combined&#xD;
        lumbar and sacral plexus blocks with a one-point puncture.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</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>
      <intervention_model_description>Using a point puncture approach instead of two punctures to perform lumbosacral plexuses block in the interventional group</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Care Provider, Outcomes Assessor)</masking>
      <masking_description>Randomization assignments will be kept in sealed envelopes until all preprocedural measurements will be completed</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Total intraoperative and postoperative opioid consumption</measure>
      <time_frame>Total fentanyl used intraoperative and total morphine consumed up to 8 hours postoperative</time_frame>
      <description>The total fentanyl doses consumed in the entire operative procedure and morphine consumed for 8 hours postoperative will be calculated.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>(NRS) score assessment in the recovery room and then it will be repeated every 2 hours for 8 hours postoperatively</measure>
      <time_frame>postoperatively pain (NRS) score assessment for 8 hours</time_frame>
      <description>Numerical Pain Score (NRS) ranges from 0 to 10, where 0 is no pain, and 10 is the worst pain imaginable. Adequate pain control will be considered at Numerical Pain Score (NRS) &lt; 4. Postoperative pain will be assessed using (the NRS) score first in the recovery room and then it will be repeated every 2 hours postoperatively for 8 hours after then.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Lower Limb Fracture</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>patients who will be recruited in the control group will receive general anesthesia only</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Interventional group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients who will be recruited in the Interventional will receive combined lumbar and sacral plexus block</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>combined Lumbar and sacral plexus block</intervention_name>
      <description>performing an ultrasound-guided combined Lumbar and sacral plexus block using one-point puncture</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Interventional group</arm_group_label>
      <other_name>No block intervention in control group</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients diagnosed with unilateral lower limb fracture by X-ray or CT examination&#xD;
  &#xD;
            -  patients with any contraindications to spinal anesthesia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  puncture site infection&#xD;
  &#xD;
            -  patients with coagulation disorders&#xD;
  &#xD;
            -  patients who refuse to participate or withdraw due to personal reasons&#xD;
  &#xD;
            -  allergy to local anesthetics.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zagazig University</investigator_affiliation>
      <investigator_full_name>Naglaa Fathy Abdelhaleem Abdelhaleem</investigator_full_name>
      <investigator_title>Lecturer, Anesthesia and Surgical Intensive Care department, Faculty of Medicine</investigator_title>
    </responsible_party>
    <!-- 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/NCT06019754
  org study id: IRB#10892
  nct id: NCT06019754
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  lumbosacral plexus block (LSPB) has been widely applied in orthopedics departments due to its
        advantages, including reduction in the application of opiates, decreasing the occurrence of
        acute pain, promoting early activation, and shortening the time of hospital stay. LSPB is a
        peripheral regional technique of anesthesia and analgesia, that provides a block of the main
        components of the lumbosacral plexus.
  Traditional ultrasound-guided lumbar plexus block combined with sacral plexus block requires
        separate blocks at different sites, requiring the lateral decubitus or prone position, which
        may be suboptimal in patients with severe pain. we present an anterior approach for combined
        lumbar and sacral plexus blocks with a one-point puncture.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Using a point puncture approach instead of two punctures to perform lumbosacral plexuses block in the interventional group
  primary purpose: Other
  masking: Double (Care Provider, Outcomes Assessor)
  masking description: Randomization assignments will be kept in sealed envelopes until all preprocedural measurements will be completed
  measure: Total intraoperative and postoperative opioid consumption
  time frame: Total fentanyl used intraoperative and total morphine consumed up to 8 hours postoperative
  description: The total fentanyl doses consumed in the entire operative procedure and morphine consumed for 8 hours postoperative will be calculated.
  measure: (NRS) score assessment in the recovery room and then it will be repeated every 2 hours for 8 hours postoperatively
  time frame: postoperatively pain (NRS) score assessment for 8 hours
  description: Numerical Pain Score (NRS) ranges from 0 to 10, where 0 is no pain, and 10 is the worst pain imaginable. Adequate pain control will be considered at Numerical Pain Score (NRS) < 4. Postoperative pain will be assessed using (the NRS) score first in the recovery room and then it will be repeated every 2 hours postoperatively for 8 hours after then.
  arm group label: Control group
  arm group type: Placebo Comparator
  description: patients who will be recruited in the control group will receive general anesthesia only
  arm group label: Interventional group
  arm group type: Active Comparator
  description: Patients who will be recruited in the Interventional will receive combined lumbar and sacral plexus block
  intervention type: Procedure
  intervention name: combined Lumbar and sacral plexus block
  description: performing an ultrasound-guided combined Lumbar and sacral plexus block using one-point puncture
  arm group label: Control group
  arm group label: Interventional group
  other name: No block intervention in control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Zagazig University
  investigator full name: Naglaa Fathy Abdelhaleem Abdelhaleem
  investigator title: Lecturer, Anesthesia and Surgical Intensive Care department, Faculty of Medicine