<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/NCT03038958</url>
  </required_header>
  <id_info>
    <org_study_id>AK160324627AD</org_study_id>
    <nct_id>NCT03038958</nct_id>
  </id_info>
  <brief_title>Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy</brief_title>
  <official_title>Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Saint Pierre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hôpital de Braine-l'Alleud</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire Saint Pierre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric&#xD;
      prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy and side&#xD;
      effects&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of sensory block</measure>
    <time_frame>Until complete release of sensory block</time_frame>
    <description>Total duration of sensory block is the interval time between the end of intrathecal injection and the complete recovery of sensory block</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Onset time of sensory block</measure>
    <time_frame>up to 30 minutes</time_frame>
    <description>The levels of sensory block will be determined at 5, 10, 20 and 30 minutes after intrathecal injection. The levels of sensory block will be assessed as loss of sensation to pin-prick and cold.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Onset time of motor block</measure>
    <time_frame>up to 30 minutes</time_frame>
    <description>The levels of motor block will be determined at 5, 10, 20 and 30 minutes after intrathecal injection. The levels of motor block will be assessed by using the Bromage Scale (0=no motor block; 1=hip blocked; 2=hip and knee blocked; 3=hip, knee, and ankle blocked).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of motor block</measure>
    <time_frame>Until complete regression of motor block</time_frame>
    <description>Total duration of motor block is the interval time between the end of intrathecal injection and the complete recovery of motor block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessed by Visual Analog Scale</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>Pain levels will be determined at the inflation of tourniquet, at the incision and every 10 minutes in the PACU (Post Anesthesia Care Unit). Visual Analog pain score (scale = 0 no pain; 10 = worst pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side-effects (hypotension, bradycardia, urinary retention)</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>Assessed during and after intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Knee Arthroscopy</condition>
  <condition>Spinal Anesthesia</condition>
  <arm_group>
    <arm_group_label>Isobaric 2-chloroprocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The 50 mg dose of isobaric 2-chloroprocaine will be administered to patients undergoing ambulatory knee arthroscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyperbaric prilocaine 2%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The dose of 50 mg of Hyperbaric prilocaine 2% will be administered to patients undergoing ambulatory knee arthroscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isobaric 2-chloroprocaine</intervention_name>
    <description>intrathecal injection of 50 mg isobaric 2-Chloroprocaine</description>
    <arm_group_label>Isobaric 2-chloroprocaine</arm_group_label>
    <other_name>Ampres</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyperbaric prilocaine</intervention_name>
    <description>intrathecal injection of 50 mg hyperbaric prilocaine 2%</description>
    <arm_group_label>Hyperbaric prilocaine 2%</arm_group_label>
    <other_name>Tachipri</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiology physical status (ASA) ≤ III&#xD;
&#xD;
          -  Age 18-80 year&#xD;
&#xD;
          -  Height between 160 and 185 cm&#xD;
&#xD;
          -  Signed informed consent obtained prior to any study specific assessments and&#xD;
             procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac pathology (such as Heart failure, Aortic stenosis)&#xD;
&#xD;
          -  Coagulation disorders (INR&gt;1.3, platelet &lt; 80 000/mm3)&#xD;
&#xD;
          -  Known allergy to local anaesthetics&#xD;
&#xD;
          -  Disagreement of the patient&#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>Emmanuel Guntz, MD</last_name>
    <role>Study Director</role>
    <affiliation>Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Panayota Kapessidou, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Braine-l'Alleud Hospital</name>
      <address>
        <city>Braine-l'Alleud</city>
        <zip>1420</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Saint-Pierre</name>
      <address>
        <city>Brussels Capital Region</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>November 15, 2019</last_update_submitted>
  <last_update_submitted_qc>November 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Local Anaesthetic</keyword>
  <keyword>spinal anesthesia</keyword>
  <keyword>Knee arthroscopy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prilocaine</mesh_term>
    <mesh_term>Chloroprocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03038958
org study id: AK160324627AD
nct id: NCT03038958
lead sponsor: 
collaborator: 
has dmc: No
This study compares intrathecal 1% plain chloroprocaine with intrathecal 2% hyperbaric
      prilocaine for patients undergoing ambulatory knee arthroscopy in terms of efficacy and side
      effects
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Duration of sensory block
time frame: Until complete release of sensory block
description: Total duration of sensory block is the interval time between the end of intrathecal injection and the complete recovery of sensory block
measure: Onset time of sensory block
time frame: up to 30 minutes
description: The levels of sensory block will be determined at 5, 10, 20 and 30 minutes after intrathecal injection. The levels of sensory block will be assessed as loss of sensation to pin-prick and cold.
measure: Onset time of motor block
time frame: up to 30 minutes
description: The levels of motor block will be determined at 5, 10, 20 and 30 minutes after intrathecal injection. The levels of motor block will be assessed by using the Bromage Scale (0=no motor block; 1=hip blocked; 2=hip and knee blocked; 3=hip, knee, and ankle blocked).
measure: Duration of motor block
time frame: Until complete regression of motor block
description: Total duration of motor block is the interval time between the end of intrathecal injection and the complete recovery of motor block
measure: Pain assessed by Visual Analog Scale
time frame: up to 24 hours
description: Pain levels will be determined at the inflation of tourniquet, at the incision and every 10 minutes in the PACU (Post Anesthesia Care Unit). Visual Analog pain score (scale = 0 no pain; 10 = worst pain imaginable).
measure: Side-effects (hypotension, bradycardia, urinary retention)
time frame: up to 24 hours
description: Assessed during and after intervention
arm group label: Isobaric 2-chloroprocaine
arm group type: Active Comparator
description: The 50 mg dose of isobaric 2-chloroprocaine will be administered to patients undergoing ambulatory knee arthroscopy
arm group label: Hyperbaric prilocaine 2%
arm group type: Active Comparator
description: The dose of 50 mg of Hyperbaric prilocaine 2% will be administered to patients undergoing ambulatory knee arthroscopy
intervention type: Drug
intervention name: Isobaric 2-chloroprocaine
description: intrathecal injection of 50 mg isobaric 2-Chloroprocaine
arm group label: Isobaric 2-chloroprocaine
other name: Ampres
intervention type: Drug
intervention name: Hyperbaric prilocaine
description: intrathecal injection of 50 mg hyperbaric prilocaine 2%
arm group label: Hyperbaric prilocaine 2%
other name: Tachipri
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Emmanuel Guntz, MD
role: Study Director
affiliation: Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital
last name: Panayota Kapessidou, MD,PhD
role: Principal Investigator
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
facility: 
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Prilocaine
mesh term: Chloroprocaine
sharing ipd: No