<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/NCT02186899</url>
  </required_header>
  <id_info>
    <org_study_id>FSOvsGA</org_study_id>
    <nct_id>NCT02186899</nct_id>
  </id_info>
  <brief_title>Peripheral Nerve Block (Femoral - Sciatic - Obturator) Versus General Anesthesia for Arthroscopic ACL Repair</brief_title>
  <official_title>Comparison of Femoral - Sciatic - Obturator Nerve Block vs General Anesthesia in Combination With Continuous or Bolus Femoral Nerve Block for Arthroscopic ACL Repair Regarding the Time of Patient Mobilasation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Larissa University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Larissa University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Arthroscopic ACL repair can be performed under different types of anesthesia. In the last few&#xD;
      years peripheral nerve blocks have increased their popularity for this kind of operation. The&#xD;
      investigators want to see how the type of anesthesia and postoperative analgesia effects the&#xD;
      time required for patient mobilisation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgery completed without pain for the patient</measure>
    <time_frame>Completion of the surgery</time_frame>
    <description>Use of VAS score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>1st postoperative day</time_frame>
    <description>Use of VAS score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mobilization of the knee</measure>
    <time_frame>24 weeks postoperatively</time_frame>
    <description>How many degrees can the patient bend the knee</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Chronic pain development</measure>
    <time_frame>24 weeks postoperatively</time_frame>
    <description>Use of questionnaire for the functional state of the knee and VAS score for the pain</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Arthroscopic ACL Rerpair</condition>
  <condition>Surgery</condition>
  <condition>Anesthesia Care</condition>
  <arm_group>
    <arm_group_label>General Anesthesia Femoral continuous</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>General anesthesia plus continuous femoral nerve block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General anesthesia Femoral bolus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>General anesthesia plus single shot femoral nerve block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Femoral Sciatic Obturator Nerve block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasound guided femoral plus sciatic plus obturator nerve block</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound Guided Femoral Sciatic Obturator nerve blocks</intervention_name>
    <arm_group_label>Femoral Sciatic Obturator Nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>General Anesthesia femoral bolus</intervention_name>
    <arm_group_label>General anesthesia Femoral bolus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>General anesthesia femoral continuous</intervention_name>
    <arm_group_label>General Anesthesia Femoral continuous</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 - 80 yrs&#xD;
&#xD;
          -  ASA I - III&#xD;
&#xD;
          -  ACL surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coagulopathy disorders&#xD;
&#xD;
          -  Infection at the puncture site for the interscalene block&#xD;
&#xD;
          -  Neurologic deficit in the arm that is going to be operated&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  BMI &gt; 35&#xD;
&#xD;
          -  Psychiatric disorders&#xD;
&#xD;
          -  Patient's refusal&#xD;
&#xD;
          -  Problems with patient communication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marina Simaioforidou, Medicine</last_name>
    <role>Study Director</role>
    <affiliation>Private Clinic of Larissa &quot;Asklipeiio&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>George Basdekis, Medicine</last_name>
    <role>Study Chair</role>
    <affiliation>Private Clinic of Larissa &quot;Asklipeiio&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Konstantinos Bargiotas, Medicine</last_name>
    <role>Study Chair</role>
    <affiliation>Larissa University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aristeidis Zibis, Medicine</last_name>
    <role>Study Chair</role>
    <affiliation>Private Clinic of Larissa &quot;Askipeiio&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Athanasios Drakos, Medicine</last_name>
    <role>Study Chair</role>
    <affiliation>Larissa University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Metaxia Bareka, Medicine</last_name>
    <role>Principal Investigator</role>
    <affiliation>Larissa University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marina Simaioforidou, Medicine</last_name>
    <phone>00306947845083</phone>
    <email>msimaiof@otenet.gr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Private Clinic of Larissa &quot;Asklipeiio&quot;</name>
      <address>
        <city>Larissa</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marina Simaioforidou, Medicine</last_name>
    </contact>
    <investigator>
      <last_name>Marina Simaioforidou, Medicine</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>April 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 7, 2014</last_update_submitted>
  <last_update_submitted_qc>July 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Larissa University Hospital</investigator_affiliation>
    <investigator_full_name>Marina Simaioforidou</investigator_full_name>
    <investigator_title>Anesthesiologist</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</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/NCT02186899
org study id: FSOvsGA
nct id: NCT02186899
lead sponsor: 
has dmc: No
Arthroscopic ACL repair can be performed under different types of anesthesia. In the last few
      years peripheral nerve blocks have increased their popularity for this kind of operation. The
      investigators want to see how the type of anesthesia and postoperative analgesia effects the
      time required for patient mobilisation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Surgery completed without pain for the patient
time frame: Completion of the surgery
description: Use of VAS score
measure: Postoperative pain
time frame: 1st postoperative day
description: Use of VAS score
measure: Mobilization of the knee
time frame: 24 weeks postoperatively
description: How many degrees can the patient bend the knee
measure: Chronic pain development
time frame: 24 weeks postoperatively
description: Use of questionnaire for the functional state of the knee and VAS score for the pain
arm group label: General Anesthesia Femoral continuous
arm group type: Active Comparator
description: General anesthesia plus continuous femoral nerve block
arm group label: General anesthesia Femoral bolus
arm group type: Active Comparator
description: General anesthesia plus single shot femoral nerve block
arm group label: Femoral Sciatic Obturator Nerve block
arm group type: Active Comparator
description: Ultrasound guided femoral plus sciatic plus obturator nerve block
intervention type: Other
intervention name: Ultrasound Guided Femoral Sciatic Obturator nerve blocks
arm group label: Femoral Sciatic Obturator Nerve block
intervention type: Other
intervention name: General Anesthesia femoral bolus
arm group label: General anesthesia Femoral bolus
intervention type: Other
intervention name: General anesthesia femoral continuous
arm group label: General Anesthesia Femoral continuous
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Marina Simaioforidou, Medicine
role: Study Director
affiliation: Private Clinic of Larissa "Asklipeiio"
last name: George Basdekis, Medicine
role: Study Chair
affiliation: Private Clinic of Larissa "Asklipeiio"
last name: Konstantinos Bargiotas, Medicine
role: Study Chair
affiliation: Larissa University Hospital
last name: Aristeidis Zibis, Medicine
role: Study Chair
affiliation: Private Clinic of Larissa "Askipeiio"
last name: Athanasios Drakos, Medicine
role: Study Chair
affiliation: Larissa University Hospital
last name: Metaxia Bareka, Medicine
role: Principal Investigator
affiliation: Larissa University Hospital
last name: Marina Simaioforidou, Medicine
phone: 00306947845083
email: msimaiof@otenet.gr
facility: 
status: Recruiting
contact: 
investigator: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Larissa University Hospital
investigator full name: Marina Simaioforidou
investigator title: Anesthesiologist
mesh term: Anesthetics