<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/NCT03753594</url>
  </required_header>
  <id_info>
    <org_study_id>XH20181118</org_study_id>
    <nct_id>NCT03753594</nct_id>
  </id_info>
  <brief_title>Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block</brief_title>
  <official_title>Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block With Ropivacaine at Different Concentrations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huazhong University of Science and Technology</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>
      Regional tissue oxygenation saturation has been shown to increase in innervated regions after&#xD;
      sympathetic block. The aim of this prospective observational study was to evaluate the&#xD;
      changes of regional tissue oxygenation saturation by near-infrared spectroscopy after&#xD;
      successful femoral nerve block with ropivacaine and determine whether the changes of regional&#xD;
      tissue oxygenation saturation can be affected by the concentration of ropivacaine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Successful peripheral nerve blocks induce sympathetic blockade, which increases local blood&#xD;
      flow by vasodilation. The relationship between successful femoral nerve block and the&#xD;
      variation of regional tissue oxygenation saturation was unclear.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Actual">May 10, 2019</completion_date>
  <primary_completion_date type="Actual">May 10, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Regional tissue oxygenation saturation after successful femoral nerve block</measure>
    <time_frame>at 5-minute intervals till 30 minutes after regional block</time_frame>
    <description>rSO2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pinprick sensory scores</measure>
    <time_frame>5 minute before regional block and at 5-minute intervals till 30 minutes after regional block</time_frame>
    <description>A 3-level scale was used to grade the intensity of sensory block using pinprick stimulation: 0=normal sensation; 1=analgesia; 2=anesthesia.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Anesthesia, Local</condition>
  <arm_group>
    <arm_group_label>H group</arm_group_label>
    <description>Patients scheduled for elective knee arthroscopy with peripheral nerve block will receive ultrasound-guided femoral nerve block with 0.5% ropivacaine. Regional tissue oxygenation saturation of the nerve innervation area and pinprick sensory tests at 5 min were assessed before the block and at 5-min intervals till 30 min after the block.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>L group</arm_group_label>
    <description>Patients scheduled for elective knee arthroscopy with peripheral nerve block will receive ultrasound-guided femoral nerve block with 0.25% ropivacaine. Regional tissue oxygenation saturation of the nerve innervation area and pinprick sensory tests were assessed at 5 min before the block and at 5-min intervals till 30 min after the block.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tissue oxygenation saturation</intervention_name>
    <description>tissue oxygenation saturation</description>
    <arm_group_label>H group</arm_group_label>
    <arm_group_label>L group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        One hundred adult patients scheduled for elective knee arthroscopy with peripheral nerve&#xD;
        block&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  American Society of Anesthesiologists physical statusⅠ-Ⅱ&#xD;
&#xD;
          -  Undergo elective elective knee arthroscopy with peripheral nerve block&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
&#xD;
          -  BMI&gt;35&#xD;
&#xD;
          -  Any contraindications to peripheral nerve block such as coagulation abnormalities,&#xD;
             •Allergy to local anaesthetics, peripheral neuropathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiangdong Chen, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Wuhan Union Hospital, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Union Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>May 10, 2019</last_update_submitted>
  <last_update_submitted_qc>May 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Xi Wu</investigator_full_name>
    <investigator_title>Principal Investigator, Department of Anesthesiology, Union Hospital of Tongji Medical College</investigator_title>
  </responsible_party>
  <keyword>Peripheral nerve block</keyword>
  <!-- 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/NCT03753594
org study id: XH20181118
nct id: NCT03753594
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Regional tissue oxygenation saturation has been shown to increase in innervated regions after
      sympathetic block. The aim of this prospective observational study was to evaluate the
      changes of regional tissue oxygenation saturation by near-infrared spectroscopy after
      successful femoral nerve block with ropivacaine and determine whether the changes of regional
      tissue oxygenation saturation can be affected by the concentration of ropivacaine.
Successful peripheral nerve blocks induce sympathetic blockade, which increases local blood
      flow by vasodilation. The relationship between successful femoral nerve block and the
      variation of regional tissue oxygenation saturation was unclear.
observational model: Cohort
time perspective: Prospective
measure: Regional tissue oxygenation saturation after successful femoral nerve block
time frame: at 5-minute intervals till 30 minutes after regional block
description: rSO2
measure: Pinprick sensory scores
time frame: 5 minute before regional block and at 5-minute intervals till 30 minutes after regional block
description: A 3-level scale was used to grade the intensity of sensory block using pinprick stimulation: 0=normal sensation; 1=analgesia; 2=anesthesia.
arm group label: H group
description: Patients scheduled for elective knee arthroscopy with peripheral nerve block will receive ultrasound-guided femoral nerve block with 0.5% ropivacaine. Regional tissue oxygenation saturation of the nerve innervation area and pinprick sensory tests at 5 min were assessed before the block and at 5-min intervals till 30 min after the block.
arm group label: L group
description: Patients scheduled for elective knee arthroscopy with peripheral nerve block will receive ultrasound-guided femoral nerve block with 0.25% ropivacaine. Regional tissue oxygenation saturation of the nerve innervation area and pinprick sensory tests were assessed at 5 min before the block and at 5-min intervals till 30 min after the block.
intervention type: Device
intervention name: tissue oxygenation saturation
description: tissue oxygenation saturation
arm group label: H group
arm group label: L group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xiangdong Chen, Doctor
role: Study Director
affiliation: Wuhan Union Hospital, China
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Xi Wu
investigator title: Principal Investigator, Department of Anesthesiology, Union Hospital of Tongji Medical College