<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/NCT03815422</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0143</org_study_id>
    <nct_id>NCT03815422</nct_id>
  </id_info>
  <brief_title>Plantar Compartment Block in Hallux Valgus Ambulatory Surgery</brief_title>
  <acronym>Observationnal</acronym>
  <official_title>Analgesia Quality and Quality of Deambulation of the Plantar Compartment Block After Hallux Valgus Ambulatory Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</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>
      Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key&#xD;
      to successful early recovery and rehabilitation.&#xD;
&#xD;
      Popliteal sciatic nerve block is widely used despite the risk of falling due to prolonged&#xD;
      motor blockade.&#xD;
&#xD;
      Plantar block combined with distal peroneal block may be a better analgesic option in order&#xD;
      to provide fast track rehabilitation.&#xD;
&#xD;
      The purpose of this study is to describe the analgesic effect of the plantar compartment&#xD;
      block following hallux valgus surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Analgesia quality of the plantar compartment block</measure>
    <time_frame>48 hours</time_frame>
    <description>after Hallux Valgus ambulatory surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of deambulation</measure>
    <time_frame>Quality of deambulation during the first 2 postoperative days.</time_frame>
    <description>48 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative analgesic</measure>
    <time_frame>postoperative analgesic requirement, during the first 2 postoperative days.</time_frame>
    <description>48 hours</description>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Hallux Valgus Ambulatory Surgery</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Regional anesthesia</intervention_name>
    <description>Short lasting sciatic nerve block and long lasting plantar block with distal deep peroneal block</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Plantar compartment block in Hallux Valgus ambulatory surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 75 years old&#xD;
&#xD;
          -  patient covered by social health insurance&#xD;
&#xD;
          -  have signed written informed consent&#xD;
&#xD;
          -  scheduled for hallux valgus ambulatory surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  protected patients or patients incapable of giving written informed consent&#xD;
&#xD;
          -  pregnant or breastfeeding woman&#xD;
&#xD;
          -  vulnerable adult&#xD;
&#xD;
          -  inability to participate in pain scoring scales&#xD;
&#xD;
          -  severe coagulopathy&#xD;
&#xD;
          -  allergy or contraindications to study drugs&#xD;
&#xD;
          -  preopérative gait disorders&#xD;
&#xD;
          -  chronic kidney disease with glomerular filtration rate (GFR) ≤ 50 ml/min (estimated by&#xD;
             the Cockroft and Gault formula)&#xD;
&#xD;
          -  severe chronic liver disease&#xD;
&#xD;
          -  chronic pain (treated by non steroidal anti inflammatory drugs, opioids, neuroleptic&#xD;
             drugs, antidepressant or anticonvulsants)&#xD;
&#xD;
          -  peripheral neuropathy&#xD;
&#xD;
          -  intervention under general anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabien SWISSER, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Early ambulation</keyword>
  <keyword>Plantar block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hallux Valgus</mesh_term>
    <mesh_term>Bunion</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>
    <ipd_description>NC</ipd_description>
  </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/NCT03815422
org study id: RECHMPL18_0143
nct id: NCT03815422
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key
      to successful early recovery and rehabilitation.

      Popliteal sciatic nerve block is widely used despite the risk of falling due to prolonged
      motor blockade.

      Plantar block combined with distal peroneal block may be a better analgesic option in order
      to provide fast track rehabilitation.

      The purpose of this study is to describe the analgesic effect of the plantar compartment
      block following hallux valgus surgery.
observational model: Cohort
time perspective: Other
measure: Analgesia quality of the plantar compartment block
time frame: 48 hours
description: after Hallux Valgus ambulatory surgery
measure: Quality of deambulation
time frame: Quality of deambulation during the first 2 postoperative days.
description: 48 hours
measure: postoperative analgesic
time frame: postoperative analgesic requirement, during the first 2 postoperative days.
description: 48 hours
intervention type: Procedure
intervention name: Regional anesthesia
description: Short lasting sciatic nerve block and long lasting plantar block with distal deep peroneal block
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fabien SWISSER, MD
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Hallux Valgus
mesh term: Bunion
mesh term: Anesthetics
sharing ipd: Undecided
ipd description: NC