<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/NCT04417608</url>
  </required_header>
  <id_info>
    <org_study_id>N202003147</org_study_id>
    <nct_id>NCT04417608</nct_id>
  </id_info>
  <brief_title>Looking for Minimum Dose to Induce Sympathectomy in Infraclavicular Brachial Plexus Block</brief_title>
  <official_title>Looking for Minimum Dose to Induce Sympathectomy in Infraclavicular Brachial Plexus Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University WanFang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University WanFang Hospital</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>
      For patients who undergoing hemodialysis, it is important to have good AV fistula. One third&#xD;
      of AV fistula usually fail during early stage. It is helpful to use nerve block to dilate the&#xD;
      blood vessels and enhance the prognosis. But 0.2% Ropivacaine usually cause muscle weakness&#xD;
      in present studies. The investigators hope to find the lowest concentration to provide&#xD;
      sympathectomy without muscle weakness. Because the patients with hemodialysis usually have&#xD;
      multiple co-morbidity, thus we choose patients with forearm fracture at the first place. With&#xD;
      this result, the investigators can design further study for patients with hemodialysis. The&#xD;
      investigators prefer proximal approach because brachial plexus run together in the&#xD;
      cosctoclavicular space and show lower incidence of incomplete work.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 4, 2020</start_date>
  <completion_date type="Anticipated">July 4, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 4, 2021</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>Change of diameter of basilic vein and brachial artery</measure>
    <time_frame>Change from baseline diameter(pre-nerve block) at 45min</time_frame>
    <description>Use ultrasound to measure the difference of diameter at different time point.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of diameter of basilic vein and brachial artery</measure>
    <time_frame>Change from baseline diameter(pre-nerve block) at 24hour</time_frame>
    <description>Use ultrasound to measure the difference of diameter at different time point.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of diameter of basilic vein and brachial artery</measure>
    <time_frame>Change from baseline diameter(pre-nerve block) at 48hour</time_frame>
    <description>Use ultrasound to measure the difference of diameter at different time point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensory block of upper limb</measure>
    <time_frame>45min post nerve block</time_frame>
    <description>A validated 3-point scale was used: 0 = no block (patient has normal sensation), 1 = patient can feel cold, but the sensation is reduced compared with the unblocked side, and 2 = complete anesthesia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensory block of upper limb</measure>
    <time_frame>24hour post nerve block</time_frame>
    <description>A validated 3-point scale was used: 0 = no block (patient has normal sensation), 1 = patient can feel cold, but the sensation is reduced compared with the unblocked side, and 2 = complete anesthesia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor block of upper limb</measure>
    <time_frame>45min post nerve block</time_frame>
    <description>A validated 3-point scale was used: 0 = no block (patient has normal power), 1 = patient can feel weakness with the unblocked side, and 2 = complete anesthesia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor block of upper limb</measure>
    <time_frame>24hour post nerve block</time_frame>
    <description>A validated 3-point scale was used: 0 = no block (patient has normal power), 1 = patient can feel weakness with the unblocked side, and 2 = complete anesthesia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor block of upper limb</measure>
    <time_frame>48hour post nerve block</time_frame>
    <description>A validated 3-point scale was used: 0 = no block (patient has normal power), 1 = patient can feel weakness with the unblocked side, and 2 = complete anesthesia.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Finding the Minimum Dose to Induce Sympathectomy in Infraclavicular</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Infraclavicular brachial plexus block</intervention_name>
    <description>Ultrasound-guided infraclavicular brachial plexus block</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are scheduled for upper limb surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 20-80 y/o, BW: 40-90 kilograms，ASA class I-III，No pre-existing&#xD;
             neuropathy，Scheduled for upper limb surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pre-existing neuropathy (ex: polyneuropathy)&#xD;
&#xD;
          2. History of allergy to xylocaine、ropivacaine、epinephrine&#xD;
&#xD;
          3. Emergent surgery&#xD;
&#xD;
          4. Coagulopathy&#xD;
&#xD;
          5. Patient who can not express themselves&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University WanFang Hospital</investigator_affiliation>
    <investigator_full_name>anchihhsu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT04417608
org study id: N202003147
nct id: NCT04417608
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
For patients who undergoing hemodialysis, it is important to have good AV fistula. One third
      of AV fistula usually fail during early stage. It is helpful to use nerve block to dilate the
      blood vessels and enhance the prognosis. But 0.2% Ropivacaine usually cause muscle weakness
      in present studies. The investigators hope to find the lowest concentration to provide
      sympathectomy without muscle weakness. Because the patients with hemodialysis usually have
      multiple co-morbidity, thus we choose patients with forearm fracture at the first place. With
      this result, the investigators can design further study for patients with hemodialysis. The
      investigators prefer proximal approach because brachial plexus run together in the
      cosctoclavicular space and show lower incidence of incomplete work.
observational model: Cohort
time perspective: Prospective
measure: Change of diameter of basilic vein and brachial artery
time frame: Change from baseline diameter(pre-nerve block) at 45min
description: Use ultrasound to measure the difference of diameter at different time point.
measure: Change of diameter of basilic vein and brachial artery
time frame: Change from baseline diameter(pre-nerve block) at 24hour
description: Use ultrasound to measure the difference of diameter at different time point.
measure: Change of diameter of basilic vein and brachial artery
time frame: Change from baseline diameter(pre-nerve block) at 48hour
description: Use ultrasound to measure the difference of diameter at different time point.
measure: Sensory block of upper limb
time frame: 45min post nerve block
description: A validated 3-point scale was used: 0 = no block (patient has normal sensation), 1 = patient can feel cold, but the sensation is reduced compared with the unblocked side, and 2 = complete anesthesia.
measure: Sensory block of upper limb
time frame: 24hour post nerve block
description: A validated 3-point scale was used: 0 = no block (patient has normal sensation), 1 = patient can feel cold, but the sensation is reduced compared with the unblocked side, and 2 = complete anesthesia.
measure: Motor block of upper limb
time frame: 45min post nerve block
description: A validated 3-point scale was used: 0 = no block (patient has normal power), 1 = patient can feel weakness with the unblocked side, and 2 = complete anesthesia.
measure: Motor block of upper limb
time frame: 24hour post nerve block
description: A validated 3-point scale was used: 0 = no block (patient has normal power), 1 = patient can feel weakness with the unblocked side, and 2 = complete anesthesia.
measure: Motor block of upper limb
time frame: 48hour post nerve block
description: A validated 3-point scale was used: 0 = no block (patient has normal power), 1 = patient can feel weakness with the unblocked side, and 2 = complete anesthesia.
intervention type: Procedure
intervention name: Infraclavicular brachial plexus block
description: Ultrasound-guided infraclavicular brachial plexus block
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University WanFang Hospital
investigator full name: anchihhsu
investigator title: Principal Investigator