<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/NCT01726192</url>
  </required_header>
  <id_info>
    <org_study_id>HLOCSTIM2</org_study_id>
    <nct_id>NCT01726192</nct_id>
  </id_info>
  <brief_title>Comparison of Two Techniques for Placement of Perineural Femoral Catheters.</brief_title>
  <acronym>HLOCSTIM2</acronym>
  <official_title>Comparison of Ultrasound Hydrolocalization Technique Versus Neurostimulation for Placement of Continuous Femoral Catheters.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Attikon Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Attikon Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy of the hydrolocalization technique for&#xD;
      placement of femoral perineural catheters in comparison with stimulating catheters. A non&#xD;
      inferiority trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will randomize patients that will undergo anterior cruciate ligament&#xD;
      reconstruction.&#xD;
&#xD;
      Each patient will receive a subgluteal single shot nerve block and a continuous femoral nerve&#xD;
      block with placement of a catheter either with the hydrolocalization technique (group HLOC)&#xD;
      or a neurostimulating catheter (group NS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <primary_completion_date type="Anticipated">January 2013</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>local anesthetic consumption</measure>
    <time_frame>36 hours postoperatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain scores with a VAS scale</measure>
    <time_frame>36 hours postoperatively</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>incidence of side effects, consumption of iv analgesics</measure>
    <time_frame>36 hours postoperatively</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Anterior Cruciate Ligament Reconstruction</condition>
  <arm_group>
    <arm_group_label>HLOC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placement of a femoral catheter with the hydrolocalization technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placement of a femoral neurostimulating catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placement of a femoral catheter with the hydrolocalization technique</intervention_name>
    <description>Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%</description>
    <arm_group_label>HLOC</arm_group_label>
    <other_name>Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placement of a femoral neurostimulating catheter</intervention_name>
    <arm_group_label>NS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults&#xD;
&#xD;
          -  BMI less than 30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known allergies to local anesthetics or other drugs used&#xD;
&#xD;
          -  patient refusal&#xD;
&#xD;
          -  any local or systemic contraindication to the use of popliteal block&#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>Tatiana F Sidiropoulou, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Attikon Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Theodosios Saranteas, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Attikon Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mario Dauri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Policlinico Tor Vergata</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tatiana F Sidiropoulou, MD, PhD</last_name>
    <phone>00302105832371</phone>
    <email>tatianasid@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Attikon Hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Tatiana F Sidiropoulou, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Theodosios Saranteas, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Policlinico Tor Vergata</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mario Dauri, MD</last_name>
      <email>mario.dauri@ptvonline.it</email>
    </contact>
    <investigator>
      <last_name>Mario Dauri, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Greece</country>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Saranteas T, Adoni A, Sidiropoulou T, Paraskeuopoulos T, Kostopanagiotou G. Combined ultrasound imaging and hydrolocalization technique for accurate placement of perineural catheters. Br J Anaesth. 2011 Dec;107(6):1008-9. doi: 10.1093/bja/aer375. No abstract available.</citation>
    <PMID>22088876</PMID>
  </reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>November 13, 2012</last_update_submitted>
  <last_update_submitted_qc>November 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Attikon Hospital</investigator_affiliation>
    <investigator_full_name>Sidiropoulou Tatiana</investigator_full_name>
    <investigator_title>Lecturer in Anesthesiology, University of Athens</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01726192
org study id: HLOCSTIM2
nct id: NCT01726192
lead sponsor: 
has dmc: No
The purpose of this study is to assess the efficacy of the hydrolocalization technique for
      placement of femoral perineural catheters in comparison with stimulating catheters. A non
      inferiority trial.
The investigators will randomize patients that will undergo anterior cruciate ligament
      reconstruction.

      Each patient will receive a subgluteal single shot nerve block and a continuous femoral nerve
      block with placement of a catheter either with the hydrolocalization technique (group HLOC)
      or a neurostimulating catheter (group NS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: local anesthetic consumption
time frame: 36 hours postoperatively
measure: Pain scores with a VAS scale
time frame: 36 hours postoperatively
measure: incidence of side effects, consumption of iv analgesics
time frame: 36 hours postoperatively
arm group label: HLOC
arm group type: Active Comparator
description: Placement of a femoral catheter with the hydrolocalization technique
arm group label: NS
arm group type: Active Comparator
description: Placement of a femoral neurostimulating catheter
intervention type: Procedure
intervention name: Placement of a femoral catheter with the hydrolocalization technique
description: Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%
arm group label: HLOC
other name: Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%
intervention type: Procedure
intervention name: Placement of a femoral neurostimulating catheter
arm group label: NS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tatiana F Sidiropoulou, MD, PhD
role: Principal Investigator
affiliation: Attikon Hospital
last name: Theodosios Saranteas, MD, PhD
role: Principal Investigator
affiliation: Attikon Hospital
last name: Mario Dauri, MD
role: Principal Investigator
affiliation: Policlinico Tor Vergata
last name: Tatiana F Sidiropoulou, MD, PhD
phone: 00302105832371
email: tatianasid@gmail.com
facility: 
status: Recruiting
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Greece
country: Italy
citation: Saranteas T, Adoni A, Sidiropoulou T, Paraskeuopoulos T, Kostopanagiotou G. Combined ultrasound imaging and hydrolocalization technique for accurate placement of perineural catheters. Br J Anaesth. 2011 Dec;107(6):1008-9. doi: 10.1093/bja/aer375. No abstract available.
PMID: 22088876
responsible party type: Principal Investigator
investigator affiliation: Attikon Hospital
investigator full name: Sidiropoulou Tatiana
investigator title: Lecturer in Anesthesiology, University of Athens
mesh term: Pain, Postoperative
mesh term: Ropivacaine