<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/NCT01698593</url>
  </required_header>
  <id_info>
    <org_study_id>RS#2009-1356</org_study_id>
    <nct_id>NCT01698593</nct_id>
  </id_info>
  <brief_title>Bupivacaine Digital Blocks: How Long is the Pain Relief and Temperature Elevation?</brief_title>
  <official_title>Bupivacaine Digital Blocks: How Long is the Pain Relief and Temperature Elevation?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lalonde, Donald H., M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lalonde, Donald H., M.D.</source>
  <brief_summary>
    <textblock>
      No one knows how long bupivacaine finger blocks last. Many use bupivacaine with and without&#xD;
      epinephrine, but no one knows how the epinephrine affects the duration of the block. We also&#xD;
      don't know how long the pain part of the block lasts, which is what counts.&#xD;
&#xD;
      The goal of the study is to determine the duration of action of bupivacaine digital nerve&#xD;
      blocks (with and without epinephrine) on finger temperature and the sensory modalities of&#xD;
      pain, touch, and pressure. 2 ml of bupivacaine 0.5% with and without epinephrine will be&#xD;
      injected at the base of each ring finger on the palm surface. At the end of 1 hr, 6 hrs, 12&#xD;
      hrs, 14 hrs and each additional hour, patients will use an insulin lancet to measure pain,&#xD;
      the Semmes Weinstein monofilament test to measure light touch and pressure and a body surface&#xD;
      thermometer to measure finger temperature. The time for the finger to return to normal&#xD;
      sensation and temperature will be measured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lidocaine finger blocks have been shown to provide analgesia for nearly 5 hours without&#xD;
      epinephrine and approximately 10 hours with epinephrine - essentially doubling its&#xD;
      duration.1,2 The analgesic effect of epinephrine on the duration of bupivacaine finger blocks&#xD;
      remains unknown.&#xD;
&#xD;
      Bupivacaine finger injection provides a much longer duration of action than lidocaine.&#xD;
      Previous studies have shown the duration of action to be as long as 24.9 hours.1 In the&#xD;
      senior author's experience, however, patients who get bupivacaine blocks start asking for&#xD;
      pain medication as early as 7 hours after the block. Is it possible that the pain blocking&#xD;
      effect of bupivacaine has a different duration than the touch and pressure effects? The&#xD;
      answer to this question also remains unknown.&#xD;
&#xD;
      The third unknown question about bupivacaine digital blocks is their effect on fingertip&#xD;
      temperature. It has been shown that lidocaine wrist blocks increase temperature in finger&#xD;
      tips, and this has been postulated to be potentially helpful in frostbite to provide pain&#xD;
      relief and hyperemia.3 Previous studies have shown bupivacaine to exhibit vasodilatory&#xD;
      properties at clinical concentrations of injection.4-7 Does bupivacaine provide increased&#xD;
      warmth to the finger tip? How long does it last?&#xD;
&#xD;
      The goals of this study are three fold: 1.) To determine what effect epinephrine has on the&#xD;
      duration of bupivacaine finger block anesthesia. 2.) To assess the duration of action of&#xD;
      bupivacaine with and without epinephrine on the digital sensory modalities of pain, touch and&#xD;
      pressure, and 3.) To assess the finger tip temperature changes that result from bupivacaine&#xD;
      digital blocks with and without epinephrine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2009</start_date>
  <completion_date type="Actual">July 2010</completion_date>
  <primary_completion_date type="Actual">July 2010</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to return of pin-prick (pain) sensation</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Ring Finger Nerve Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine 0.5%</intervention_name>
    <arm_group_label>Ring Finger Nerve Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine 0.5% + Epinephrine (1:200,000)</intervention_name>
    <arm_group_label>Ring Finger Nerve Block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult volunteer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under the age of majority&#xD;
&#xD;
          -  Unable to give consent&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Allergy to local anesthetic&#xD;
&#xD;
          -  Prior finger surgery&#xD;
&#xD;
          -  Preexisting digital vascular ischemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Saint John Regional Hospital</name>
      <address>
        <city>Saint John</city>
        <state>New Brunswick</state>
        <zip>E2L 4L2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bupivacaine</keyword>
  <keyword>digital nerve block</keyword>
  <keyword>epinephrine</keyword>
  <keyword>duration of action</keyword>
  <keyword>pain</keyword>
  <keyword>touch</keyword>
  <keyword>pressure</keyword>
  <keyword>temperature</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperthermia</mesh_term>
    <mesh_term>Fever</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Bupivacaine</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/NCT01698593
org study id: RS#2009-1356
nct id: NCT01698593
lead sponsor: 
No one knows how long bupivacaine finger blocks last. Many use bupivacaine with and without
      epinephrine, but no one knows how the epinephrine affects the duration of the block. We also
      don't know how long the pain part of the block lasts, which is what counts.

      The goal of the study is to determine the duration of action of bupivacaine digital nerve
      blocks (with and without epinephrine) on finger temperature and the sensory modalities of
      pain, touch, and pressure. 2 ml of bupivacaine 0.5% with and without epinephrine will be
      injected at the base of each ring finger on the palm surface. At the end of 1 hr, 6 hrs, 12
      hrs, 14 hrs and each additional hour, patients will use an insulin lancet to measure pain,
      the Semmes Weinstein monofilament test to measure light touch and pressure and a body surface
      thermometer to measure finger temperature. The time for the finger to return to normal
      sensation and temperature will be measured.
Lidocaine finger blocks have been shown to provide analgesia for nearly 5 hours without
      epinephrine and approximately 10 hours with epinephrine - essentially doubling its
      duration.1,2 The analgesic effect of epinephrine on the duration of bupivacaine finger blocks
      remains unknown.

      Bupivacaine finger injection provides a much longer duration of action than lidocaine.
      Previous studies have shown the duration of action to be as long as 24.9 hours.1 In the
      senior author's experience, however, patients who get bupivacaine blocks start asking for
      pain medication as early as 7 hours after the block. Is it possible that the pain blocking
      effect of bupivacaine has a different duration than the touch and pressure effects? The
      answer to this question also remains unknown.

      The third unknown question about bupivacaine digital blocks is their effect on fingertip
      temperature. It has been shown that lidocaine wrist blocks increase temperature in finger
      tips, and this has been postulated to be potentially helpful in frostbite to provide pain
      relief and hyperemia.3 Previous studies have shown bupivacaine to exhibit vasodilatory
      properties at clinical concentrations of injection.4-7 Does bupivacaine provide increased
      warmth to the finger tip? How long does it last?

      The goals of this study are three fold: 1.) To determine what effect epinephrine has on the
      duration of bupivacaine finger block anesthesia. 2.) To assess the duration of action of
      bupivacaine with and without epinephrine on the digital sensory modalities of pain, touch and
      pressure, and 3.) To assess the finger tip temperature changes that result from bupivacaine
      digital blocks with and without epinephrine.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Time to return of pin-prick (pain) sensation
time frame: 24 hours
arm group label: Ring Finger Nerve Block
arm group type: Active Comparator
intervention type: Drug
intervention name: Bupivacaine 0.5%
arm group label: Ring Finger Nerve Block
intervention type: Drug
intervention name: Bupivacaine 0.5% + Epinephrine (1:200,000)
arm group label: Ring Finger Nerve Block
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Hyperthermia
mesh term: Fever
mesh term: Epinephrine
mesh term: Bupivacaine