<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/NCT02229578</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201400019</org_study_id>
    <secondary_id>OCR18920</secondary_id>
    <nct_id>NCT02229578</nct_id>
  </id_info>
  <brief_title>Lidocaine For Treatment of Post-operative Pain From Donor Sites Following Burn Injury.</brief_title>
  <acronym>LidocaineBurn</acronym>
  <official_title>Lidocaine In The Treatment of Post-operative Pain Management From a Donor Site After Split Thickness Skin Graft Harvesting Following Thermal Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Burn pain is known to be one the most severe forms of acute pain often requiring large&#xD;
      amounts of narcotics in addition to other adjuvants. Topical lidocaine is effective for&#xD;
      controlling pain in various settings including dressing changes of burns. The aim of this&#xD;
      study is to demonstrate the effectiveness of topical lidocaine in decreasing pain scores and&#xD;
      narcotic requirements when applied to donor graft sites while at the same time not&#xD;
      interfering with the standard of care TheraBond dressing. During this study the investiagtors&#xD;
      will be monitoring for evidence of delayed wound healing, and surgical site infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pain from burns is a severe form of acute pain that requires aggressive use of opioids. Even&#xD;
      with the implementation of multiple modalities for analgesia, pain from skin debridements and&#xD;
      grafting procedures remains a challenge to control. Local anesthetics have been used for pain&#xD;
      relief in burn patients previously as a topical gel or IV infusion and have been found to&#xD;
      significantly reduce medication consumption, without apparent adverse effects on wound&#xD;
      healing. Lidocaine actually has potent anti-inflammatory effects which could be advantageous&#xD;
      on wounds. In addition, topical application of lidocaine to wounds result in different&#xD;
      degrees of systemic absorption. High concentrations of lidocaine have potential for central&#xD;
      nervous system (seizures (&gt;5mg/L)) and cardiovascular toxicity (arrhythmias (&gt;9mg/L)). Plasma&#xD;
      concentration of lidocaine depend upon drug dose, rate of absorption, patient weight,&#xD;
      physical status and thickness of skin harvested. A prior study where up to 6.7mg/kg of 2%&#xD;
      lidocaine with epinephrine was sprayed on donor graft sites found that systemic lidocaine&#xD;
      levels were far below toxic levels at their peak (average level of 1.4, with maximum level at&#xD;
      2.2). In this study the levels peaked between 30 and 60 minutes and systemic levels of&#xD;
      lidocaine were detectable 6 hours following application of the solution. Studies have&#xD;
      demonstrated the beneficial effects of systemic lidocaine administered via IV infusions in&#xD;
      reducing perioperative pain scores.Topical lidocaine is effective as a topical anesthetic in&#xD;
      multiple clinical trials however only two studies to date has shown that topical lidocaine&#xD;
      applied to skin-harvest sites produces an analgesic effect, reduces narcotic requirements&#xD;
      while not affecting wound healing or causing toxic blood concentrations. In both these&#xD;
      studies systemic intravenous lidocaine levels were monitored and were found to be&#xD;
      significantly below toxic limits. The use of topical lidocaine on donor sites is still not&#xD;
      widely used, partly for fear the lidocaine will interfere with wound healing and/or dressing&#xD;
      adherence. No study to date has demonstrated lidocaine solution to be effective on burn sites&#xD;
      when used in conjunction with TheraBond silver foam dressing. TheraBond is an absorbent,&#xD;
      atraumatic dressing coated with ionic silver that is routinely used on donor sites at the&#xD;
      University of Florida. This study will also offer additional supporting evidence that topical&#xD;
      lidocaine is effective in post operative pain management of donor skin sites and should be&#xD;
      more widely utilized. In addition, this study will serve as a stepping stone for analyzing&#xD;
      different local anesthetic solutions in the future and the potential for reapplication to&#xD;
      surgical sites.&#xD;
&#xD;
      The purpose of this study is to offer the medical community data on a simple and relatively&#xD;
      cheap adjuvant that can be utilized to help reduce the amount of post-operative pain and&#xD;
      narcotic requirement in burn patients requiring skin grafts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Anticipated">March 3, 2024</completion_date>
  <primary_completion_date type="Actual">April 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain improvement</measure>
    <time_frame>24 hours</time_frame>
    <description>Improvement of pain perception for those receiving lidocaine vs those that do not using reported pain scale (zero through ten). The amount of narcotics utilized will also documented and compared between groups.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Lidocaine Treatment Group</arm_group_label>
    <description>Subjects in this group will receive a nonpyrogenic solution of lidocaine 2% in isotonic saline (Solution A) sprayed on the donor site of the grafted skin prior to emergence from general anesthesia. A total maximum of 7mg/kg of lidocaine solution will be available for administration. Prior to spraying of the Solution A, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Treatment Group</arm_group_label>
    <description>Subjects in this group will receive a nonpyrogenic solution of isotonic saline (Solution B) sprayed over the donor site. Prior to spraying of the Solution B, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Subjects in this group will receive a nonpyrogenic solution of lidocaine 2% in isotonic saline (Solution A) sprayed on the donor site of the grafted skin prior to emergence from general anesthesia. A total maximum of 7mg/kg of lidocaine solution will be available for administration. Prior to spraying of the Solution A, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.</description>
    <arm_group_label>Lidocaine Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects in this group will receive a nonpyrogenic solution of isotonic saline (Solution B) sprayed over the donor site. Prior to spraying of the Solution B, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.</description>
    <arm_group_label>Placebo Treatment Group</arm_group_label>
    <other_name>Saline</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient accessing burn treatment services at an area hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients who have suffered second to third degree burns requiring a single split&#xD;
             thickness skin graft surgery.&#xD;
&#xD;
          -  Donor sites will be between 3-15% TBSA.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have history of chronic pain,&#xD;
&#xD;
          -  opioid abuse history,&#xD;
&#xD;
          -  major renal and/or liver dysfunction,&#xD;
&#xD;
          -  history of seizures or major neurologic deficiencies,&#xD;
&#xD;
          -  allergy to local anesthetics,&#xD;
&#xD;
          -  reported allergy to hydromorphone,&#xD;
&#xD;
          -  pregnancy, or&#xD;
&#xD;
          -  currently have other injuries that significantly contribute to pain (i.e. multi-trauma&#xD;
             patients) will be excluded from the study.&#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>
  <overall_official>
    <last_name>Brenda Fahy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shands Hospital, University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shands Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Burn pain</keyword>
  <keyword>lidocaine</keyword>
  <keyword>donor site pain</keyword>
  <keyword>Narcotic use</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</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/NCT02229578
org study id: IRB201400019
secondary id: OCR18920
nct id: NCT02229578
lead sponsor: 
has dmc: No
Burn pain is known to be one the most severe forms of acute pain often requiring large
      amounts of narcotics in addition to other adjuvants. Topical lidocaine is effective for
      controlling pain in various settings including dressing changes of burns. The aim of this
      study is to demonstrate the effectiveness of topical lidocaine in decreasing pain scores and
      narcotic requirements when applied to donor graft sites while at the same time not
      interfering with the standard of care TheraBond dressing. During this study the investiagtors
      will be monitoring for evidence of delayed wound healing, and surgical site infection.
Pain from burns is a severe form of acute pain that requires aggressive use of opioids. Even
      with the implementation of multiple modalities for analgesia, pain from skin debridements and
      grafting procedures remains a challenge to control. Local anesthetics have been used for pain
      relief in burn patients previously as a topical gel or IV infusion and have been found to
      significantly reduce medication consumption, without apparent adverse effects on wound
      healing. Lidocaine actually has potent anti-inflammatory effects which could be advantageous
      on wounds. In addition, topical application of lidocaine to wounds result in different
      degrees of systemic absorption. High concentrations of lidocaine have potential for central
      nervous system (seizures (>5mg/L)) and cardiovascular toxicity (arrhythmias (>9mg/L)). Plasma
      concentration of lidocaine depend upon drug dose, rate of absorption, patient weight,
      physical status and thickness of skin harvested. A prior study where up to 6.7mg/kg of 2%
      lidocaine with epinephrine was sprayed on donor graft sites found that systemic lidocaine
      levels were far below toxic levels at their peak (average level of 1.4, with maximum level at
      2.2). In this study the levels peaked between 30 and 60 minutes and systemic levels of
      lidocaine were detectable 6 hours following application of the solution. Studies have
      demonstrated the beneficial effects of systemic lidocaine administered via IV infusions in
      reducing perioperative pain scores.Topical lidocaine is effective as a topical anesthetic in
      multiple clinical trials however only two studies to date has shown that topical lidocaine
      applied to skin-harvest sites produces an analgesic effect, reduces narcotic requirements
      while not affecting wound healing or causing toxic blood concentrations. In both these
      studies systemic intravenous lidocaine levels were monitored and were found to be
      significantly below toxic limits. The use of topical lidocaine on donor sites is still not
      widely used, partly for fear the lidocaine will interfere with wound healing and/or dressing
      adherence. No study to date has demonstrated lidocaine solution to be effective on burn sites
      when used in conjunction with TheraBond silver foam dressing. TheraBond is an absorbent,
      atraumatic dressing coated with ionic silver that is routinely used on donor sites at the
      University of Florida. This study will also offer additional supporting evidence that topical
      lidocaine is effective in post operative pain management of donor skin sites and should be
      more widely utilized. In addition, this study will serve as a stepping stone for analyzing
      different local anesthetic solutions in the future and the potential for reapplication to
      surgical sites.

      The purpose of this study is to offer the medical community data on a simple and relatively
      cheap adjuvant that can be utilized to help reduce the amount of post-operative pain and
      narcotic requirement in burn patients requiring skin grafts.
observational model: Cohort
time perspective: Prospective
measure: Pain improvement
time frame: 24 hours
description: Improvement of pain perception for those receiving lidocaine vs those that do not using reported pain scale (zero through ten). The amount of narcotics utilized will also documented and compared between groups.
arm group label: Lidocaine Treatment Group
description: Subjects in this group will receive a nonpyrogenic solution of lidocaine 2% in isotonic saline (Solution A) sprayed on the donor site of the grafted skin prior to emergence from general anesthesia. A total maximum of 7mg/kg of lidocaine solution will be available for administration. Prior to spraying of the Solution A, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.
arm group label: Placebo Treatment Group
description: Subjects in this group will receive a nonpyrogenic solution of isotonic saline (Solution B) sprayed over the donor site. Prior to spraying of the Solution B, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.
intervention type: Drug
intervention name: Lidocaine
description: Subjects in this group will receive a nonpyrogenic solution of lidocaine 2% in isotonic saline (Solution A) sprayed on the donor site of the grafted skin prior to emergence from general anesthesia. A total maximum of 7mg/kg of lidocaine solution will be available for administration. Prior to spraying of the Solution A, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.
arm group label: Lidocaine Treatment Group
intervention type: Drug
intervention name: Placebo
description: Subjects in this group will receive a nonpyrogenic solution of isotonic saline (Solution B) sprayed over the donor site. Prior to spraying of the Solution B, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.
arm group label: Placebo Treatment Group
other name: Saline
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Brenda Fahy, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Lidocaine