<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/NCT01704612</url>
  </required_header>
  <id_info>
    <org_study_id>2011-PC001</org_study_id>
    <nct_id>NCT01704612</nct_id>
  </id_info>
  <brief_title>Evaluation of Block Duration in Type 2 Diabetes Patients</brief_title>
  <acronym>Diabeteblock</acronym>
  <official_title>Comparison of Subgluteal Sciatic Nerve Block Duration in Type-2 Diabetic and Non Diabetic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pierre and Marie Curie University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pierre and Marie Curie University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabete animal studies demonstrated a longer period recovery after local anesthetic injection&#xD;
      (perineural administration). No clinical study demonstrated a prolonged nerve block duration&#xD;
      in diabete type 2 patients after peripheral nerve block. The investigators hypothesized that&#xD;
      block recovery is delayed in diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For diabetic patients, peripheral nerve block is an interesting alternative to general&#xD;
      anesthesia because it provides effective analgesia and may decrease haemodynamic&#xD;
      complication. The fear of nerve injury after regional anaesthesia in diabetic patients is a&#xD;
      concern that has neither been confirmed nor refuted by current literature. As a matter of&#xD;
      fact, diabetic patients with neuropathy may be considered at increased risk because of the&#xD;
      possibility for double crush syndrome when a chronic axon lesion related to diabetes is&#xD;
      associated with an unexpected distal nerve injury related to regional anaesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the duration of sensory block in hours</measure>
    <time_frame>Day 0</time_frame>
    <description>The beginning of this term is defined by the end of the sciatic block injection, and the end of this period is defined by the reappearance of sensitivity to pin-prick test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the duration of motor sciatic block</measure>
    <time_frame>Day 0</time_frame>
    <description>The beginning of this term is defined by the end of the sciatic block injection, and the end of this period is defined by the reappearance of motor function</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Time necessary for onset sensory and motor block time in minutes</measure>
    <time_frame>Day 0</time_frame>
    <description>peroperative period</description>
  </other_outcome>
  <other_outcome>
    <measure>Failure of the block: yes/no</measure>
    <time_frame>Day 0</time_frame>
    <description>perop</description>
  </other_outcome>
  <other_outcome>
    <measure>occurrence of neurological omplications, yes/no</measure>
    <time_frame>1 month</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Diabetes Type 2</condition>
  <arm_group>
    <arm_group_label>Diabete group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient with type 2 diabete received 20 mL ropivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>no diabete reveived 20 mL ropivacaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ropivacaine</intervention_name>
    <description>patients received 20 mL ropivacaine 5 mg/mL on subgluteal nerve</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Diabete group</arm_group_label>
    <other_name>naropin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age (50 80 yrs) with monofilament test 10 g (&gt; 4/8)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal of sciatic nerve block,&#xD;
&#xD;
          -  age &lt; 50 yr or &gt; 80 yr,&#xD;
&#xD;
          -  American Society of Anesthesiologists state &gt; IV,&#xD;
&#xD;
          -  presence of contraindications to local anaesthesia (known allergy to local&#xD;
             anaesthetics, sepsis),&#xD;
&#xD;
          -  emergency surgery,&#xD;
&#xD;
          -  patients unlikely to be fully cooperative during the study,&#xD;
&#xD;
          -  psychiatric disorders, or&#xD;
&#xD;
          -  those abusing alcohol or drugs, and&#xD;
&#xD;
          -  participation in another study within the previous 30 days. Moreover, patients with&#xD;
             preoperative estimated values of creatinine clearance &lt; 50 mL min-1 (Cockroft and&#xD;
             Gault Formula) or with glycosylated hemoglobin (A1c) level &gt; 8 % or with type 1&#xD;
             diabetes mellitus (insulin therapy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe Cuvillon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP Pitié Salpetriere</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>APHP Pitié-Sampetriere</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>October 7, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>December 21, 2012</last_update_submitted>
  <last_update_submitted_qc>December 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire de Nīmes</investigator_affiliation>
    <investigator_full_name>Philippe Cuvillon</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>local anesthetic</keyword>
  <keyword>sciatic</keyword>
  <keyword>diabetes</keyword>
  <keyword>block</keyword>
  <keyword>duration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT01704612
org study id: 2011-PC001
nct id: NCT01704612
lead sponsor: 
collaborator: 
has dmc: Yes
Diabete animal studies demonstrated a longer period recovery after local anesthetic injection
      (perineural administration). No clinical study demonstrated a prolonged nerve block duration
      in diabete type 2 patients after peripheral nerve block. The investigators hypothesized that
      block recovery is delayed in diabetic patients.
For diabetic patients, peripheral nerve block is an interesting alternative to general
      anesthesia because it provides effective analgesia and may decrease haemodynamic
      complication. The fear of nerve injury after regional anaesthesia in diabetic patients is a
      concern that has neither been confirmed nor refuted by current literature. As a matter of
      fact, diabetic patients with neuropathy may be considered at increased risk because of the
      possibility for double crush syndrome when a chronic axon lesion related to diabetes is
      associated with an unexpected distal nerve injury related to regional anaesthesia.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: the duration of sensory block in hours
time frame: Day 0
description: The beginning of this term is defined by the end of the sciatic block injection, and the end of this period is defined by the reappearance of sensitivity to pin-prick test
measure: the duration of motor sciatic block
time frame: Day 0
description: The beginning of this term is defined by the end of the sciatic block injection, and the end of this period is defined by the reappearance of motor function
measure: Time necessary for onset sensory and motor block time in minutes
time frame: Day 0
description: peroperative period
measure: Failure of the block: yes/no
time frame: Day 0
description: perop
measure: occurrence of neurological omplications, yes/no
time frame: 1 month
arm group label: Diabete group
arm group type: Active Comparator
description: Patient with type 2 diabete received 20 mL ropivacaine
arm group label: Control group
arm group type: Sham Comparator
description: no diabete reveived 20 mL ropivacaine
intervention type: Drug
intervention name: ropivacaine
description: patients received 20 mL ropivacaine 5 mg/mL on subgluteal nerve
arm group label: Control group
arm group label: Diabete group
other name: naropin
criteria: 
gender: All
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philippe Cuvillon, PhD
role: Principal Investigator
affiliation: APHP Pitié Salpetriere
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire de Nīmes
investigator full name: Philippe Cuvillon
investigator title: MD, PhD
mesh term: Diabetes Mellitus, Type 2
mesh term: Ropivacaine