<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/NCT03824717</url>
  </required_header>
  <id_info>
    <org_study_id>112062</org_study_id>
    <nct_id>NCT03824717</nct_id>
  </id_info>
  <brief_title>MEV 90 of 0.5% Ropivacaine In Infraclavicular Blocks</brief_title>
  <acronym>MEV90ROPI</acronym>
  <official_title>Minimum Effective Volume of 0.5% Ropivacaine for Ultrasound-Guided Infraclavicular Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Nerve blocks are routinely performed perioperatively to provide anesthesia and analgesia for&#xD;
      various surgical procedures on the upper limb. These blocks are performed with the aid of an&#xD;
      ultrasound machine to improve the success rate. Below the clavicle approach to these nerves&#xD;
      is used for surgeries below the elbow, forearm and hand efficiently.&#xD;
&#xD;
      Ultrasound guidance for such blocks allows direct visualisation of the needle and the spread&#xD;
      of the freezing medication (local anesthetic) in real-time therefore reducing complications&#xD;
      and improving success rates of blocks. It may be possible that a smaller volume of local&#xD;
      anesthetic in this setting may allow effective anesthesia while lowering the adverse effects.&#xD;
      The aim of this study is to find out the lowest volume of the local anesthetic that will be&#xD;
      effective in blocking the nerves adequately.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a dose finding study. Volume assignment of ropivacaine will be carried out using a&#xD;
      Biased Coin Design up and down method. In this method, the volume of local anesthetic&#xD;
      (ropivacaine) administered to each patient will depends on the response of the previous&#xD;
      patient. In the event of block failure, the next subject will receive an additional 2 mL of&#xD;
      volume compared with the previous patient. In the event of block success, the next patient&#xD;
      will receive either the same volume as the last patient or a 2 mL reduction in volume (per&#xD;
      the biased coin design with a probability of the same volume being 0.9 and lower volume being&#xD;
      0.1). The first patient in the study will receive 30 mL and depending on the block success,&#xD;
      the volume of the next block will be increased or decreased. The biased coin design is well&#xD;
      described and established in other minimum volume studies.&#xD;
&#xD;
      All patients will have the block in the block room with standard monitoring (non-invasive&#xD;
      blood pressure, pulse-oximetry, electrocardiogram) and mild sedation with midazolam and&#xD;
      fentanyl. All blocks will be performed by staff anesthesiologists with a subspecialty in&#xD;
      regional anesthesia and who work routinely in the block room or by a resident or fellow who&#xD;
      is directly supervised by one of these staff anesthesiologist.&#xD;
&#xD;
      There will be two follow up telephone call to all patients enrolled in this study 24 hours&#xD;
      post block insertion and one at 7 days to discuss length of block duration, any postoperative&#xD;
      nausea/vomiting, any ongoing numbness or tingling, and overall satisfaction with the block.&#xD;
      The participants will be informed of this phone call as part of the consent process and their&#xD;
      telephone number will be confirmed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Biased coin design and up and down method to determine the minimum effective volume of Ropivacaine in ultrasound guided infraclavicular brachial plexus blocks.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>There is no masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>ED90 of 0.5% Ropivacaine</measure>
    <time_frame>30 minutes</time_frame>
    <description>Volume used to achieve sensory and motor blockade (surgical anesthesia)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical anesthesia</measure>
    <time_frame>30 minutes</time_frame>
    <description>Sensory and motor blockade tested using pin prick sensation ( 0 - normal sensation and can feel pin-prick, 1 - touch only, 2 - no sensation of touch or pinprick) and motor function of the ulnar, radial and median nerves.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Duration of sensory anesthesia</measure>
    <time_frame>8 to 10 hours</time_frame>
    <description>Duration of analgesia - time from administration of block to Visual analogue scale score more than 4 or patient request for first analgesic dose</description>
  </other_outcome>
  <other_outcome>
    <measure>Complications during block placement</measure>
    <time_frame>30 minutes</time_frame>
    <description>Incidence of paresthesia during needle insertion, vascular or pleural puncture</description>
  </other_outcome>
  <other_outcome>
    <measure>Postoperative complications 24 hours and 7 days</measure>
    <time_frame>24 hours and 7 days</time_frame>
    <description>Presence or absence of tingling, numbness, weakness of limb will be noted. Patient satisfaction as satisfied or unsatisfied will be noted.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">55</enrollment>
  <condition>Infraclavicular Brachial Plexus Block</condition>
  <arm_group>
    <arm_group_label>Ropivacaine dosage</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Dose finding study - The volume of 0.5% ropivacaine used to achieve surgical anesthesia in infraclavicular brachial plexus block</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dose of ropivacaine</intervention_name>
    <description>Biased coin design up and down dose finding study of 0.5% ropivacaine to achieve a successful infraclavicular brachial plexus block</description>
    <arm_group_label>Ropivacaine dosage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 to 80 years&#xD;
&#xD;
          -  Amercian Society of Anesthesia physical status I, II, III&#xD;
&#xD;
          -  Patients undergoing upper limb surgeries (with/without sedation)&#xD;
&#xD;
          -  Ability to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Known history of sensitivity or contraindications to study drugs&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Infection at the site of administration of block&#xD;
&#xD;
          -  Significant blood coagulation disorders&#xD;
&#xD;
          -  Neurological deficits involving brachial plexus&#xD;
&#xD;
          -  Patients on any medication which is known to have drug interactions with the study&#xD;
             drugs&#xD;
&#xD;
          -  Patients who receive general anesthesia/ narcotic supplements&#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_contact>
    <last_name>Shalini Dhir, MD, FRCPC</last_name>
    <phone>+1 519 646 6000</phone>
    <phone_ext>64219</phone_ext>
    <email>shalini.dhir@sjhc.london.on.ca</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ropivacaine</keyword>
  <keyword>Brachial plexus block</keyword>
  <keyword>Infraclavicular block</keyword>
  <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/NCT03824717
org study id: 112062
nct id: NCT03824717
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Nerve blocks are routinely performed perioperatively to provide anesthesia and analgesia for
      various surgical procedures on the upper limb. These blocks are performed with the aid of an
      ultrasound machine to improve the success rate. Below the clavicle approach to these nerves
      is used for surgeries below the elbow, forearm and hand efficiently.

      Ultrasound guidance for such blocks allows direct visualisation of the needle and the spread
      of the freezing medication (local anesthetic) in real-time therefore reducing complications
      and improving success rates of blocks. It may be possible that a smaller volume of local
      anesthetic in this setting may allow effective anesthesia while lowering the adverse effects.
      The aim of this study is to find out the lowest volume of the local anesthetic that will be
      effective in blocking the nerves adequately.
This is a dose finding study. Volume assignment of ropivacaine will be carried out using a
      Biased Coin Design up and down method. In this method, the volume of local anesthetic
      (ropivacaine) administered to each patient will depends on the response of the previous
      patient. In the event of block failure, the next subject will receive an additional 2 mL of
      volume compared with the previous patient. In the event of block success, the next patient
      will receive either the same volume as the last patient or a 2 mL reduction in volume (per
      the biased coin design with a probability of the same volume being 0.9 and lower volume being
      0.1). The first patient in the study will receive 30 mL and depending on the block success,
      the volume of the next block will be increased or decreased. The biased coin design is well
      described and established in other minimum volume studies.

      All patients will have the block in the block room with standard monitoring (non-invasive
      blood pressure, pulse-oximetry, electrocardiogram) and mild sedation with midazolam and
      fentanyl. All blocks will be performed by staff anesthesiologists with a subspecialty in
      regional anesthesia and who work routinely in the block room or by a resident or fellow who
      is directly supervised by one of these staff anesthesiologist.

      There will be two follow up telephone call to all patients enrolled in this study 24 hours
      post block insertion and one at 7 days to discuss length of block duration, any postoperative
      nausea/vomiting, any ongoing numbness or tingling, and overall satisfaction with the block.
      The participants will be informed of this phone call as part of the consent process and their
      telephone number will be confirmed.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Biased coin design and up and down method to determine the minimum effective volume of Ropivacaine in ultrasound guided infraclavicular brachial plexus blocks.
primary purpose: Treatment
masking: None (Open Label)
masking description: There is no masking
measure: ED90 of 0.5% Ropivacaine
time frame: 30 minutes
description: Volume used to achieve sensory and motor blockade (surgical anesthesia)
measure: Surgical anesthesia
time frame: 30 minutes
description: Sensory and motor blockade tested using pin prick sensation ( 0 - normal sensation and can feel pin-prick, 1 - touch only, 2 - no sensation of touch or pinprick) and motor function of the ulnar, radial and median nerves.
measure: Duration of sensory anesthesia
time frame: 8 to 10 hours
description: Duration of analgesia - time from administration of block to Visual analogue scale score more than 4 or patient request for first analgesic dose
measure: Complications during block placement
time frame: 30 minutes
description: Incidence of paresthesia during needle insertion, vascular or pleural puncture
measure: Postoperative complications 24 hours and 7 days
time frame: 24 hours and 7 days
description: Presence or absence of tingling, numbness, weakness of limb will be noted. Patient satisfaction as satisfied or unsatisfied will be noted.
arm group label: Ropivacaine dosage
arm group type: Other
description: Dose finding study - The volume of 0.5% ropivacaine used to achieve surgical anesthesia in infraclavicular brachial plexus block
intervention type: Drug
intervention name: Dose of ropivacaine
description: Biased coin design up and down dose finding study of 0.5% ropivacaine to achieve a successful infraclavicular brachial plexus block
arm group label: Ropivacaine dosage
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Shalini Dhir, MD, FRCPC
phone: +1 519 646 6000
phone ext: 64219
email: shalini.dhir@sjhc.london.on.ca
responsible party type: Sponsor
mesh term: Ropivacaine