<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/NCT01718262</url>
  </required_header>
  <id_info>
    <org_study_id>353368-19</org_study_id>
    <nct_id>NCT01718262</nct_id>
  </id_info>
  <brief_title>Study Measuring Total Plasma Ropivacaine Levels During Continuous Peripheral Nerve Catheter Infusion</brief_title>
  <official_title>Study Measuring Total Plasma Ropivacaine Levels During Continuous Peripheral Nerve Catheter Infusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Defense and Veterans Center for Integrative Pain Management</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Defense and Veterans Center for Integrative Pain Management</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to measure the blood levels of the medicine called ropivacaine&#xD;
      (local anesthetic) used to manage pain. Ropivacaine is a widely used medication and is not&#xD;
      the subject of this study, but the investigators are studying how much of the drug can be&#xD;
      found in the patient's blood, known as the blood level, of this medicine. Too much&#xD;
      ropivacaine in a patient's blood can lead to local anesthetic toxicity. Once the nerve&#xD;
      catheter is removed, local anesthetic toxicity is no longer a potential problem. However,&#xD;
      there is little data on what ropivacaine blood levels are after having the catheter in for a&#xD;
      long period of time(up to one month).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2010</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</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>Plasma Ropivicaine Levels</measure>
    <time_frame>up to 10 days</time_frame>
    <description>Blood will be drawn every 0, 3, 5, 7, and 10 days. Blood is drawn every 3 days thereafter.</description>
  </primary_outcome>
  <enrollment type="Actual">49</enrollment>
  <condition>Anesthesia</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The plasma ropivacaine samples will be assayed at the Department of Research Programs&#xD;
      Laboratory (DRP) at WRNMMC. Once the whole blood sample has been centrifuged, the plasma will&#xD;
      be removed with a glass pipette, placed in a storage container. The blood samples will be&#xD;
      labeled with a non sequential serial number and will not include the time of the blood draw.&#xD;
      This will blind the DRP laboratory to the patient's identity and timing of the blood draw.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Military health care beneficiaries age 18 years and older presenting for upper or lower&#xD;
        extremity surgery requiring continuous infusions of local anesthetic either at WRNMMC will&#xD;
        be asked to participate in the study. We will recruit up to fifty patients for the study at&#xD;
        WRNMMC.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females 18 years and older, capable of providing informed consent indicating&#xD;
             awareness of the investigational nature of the study, in keeping with institutional&#xD;
             policy&#xD;
&#xD;
          -  Written informed consent must be obtained from each patient prior to entering the&#xD;
             study&#xD;
&#xD;
          -  Patients must be scheduled to receive a continuous peripheral nerve catheter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to have serial blood drawn&#xD;
&#xD;
          -  Contraindication for a continuous peripheral nerve catheter (allergy to local&#xD;
             anesthetic, infection at site of injection, elevated coagulation times (international&#xD;
             normalized ratio (INR)&gt;1.5, partial thromboplastin time (PTT)&gt;38; these values are&#xD;
             drawn as part of routine standard of care and those values will be checked prior to&#xD;
             initial catheter insertion), therapeutic dosing of anticoagulation medication,&#xD;
             moderate to severe head injury and moderate to severe traumatic brain injury&#xD;
&#xD;
          -  Patients with a hematocrit &lt; 20. Complete Blood Counts (CBCs) are drawn as part of&#xD;
             routine standard of care and will be followed by the Acute Pain Service. Although the&#xD;
             CBCs and ropivacaine blood draws will not always coincide, we will always check the&#xD;
             last hematocrit obtained prior to our blood draw&#xD;
&#xD;
          -  Severe liver or renal disease (values greater than two times normal range)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20889</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>August 9, 2019</last_update_submitted>
  <last_update_submitted_qc>August 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ropivacaine Level</keyword>
  <keyword>continuous peripheral nerve blocks.</keyword>
  <!-- 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/NCT01718262
org study id: 353368-19
nct id: NCT01718262
lead sponsor: 
has dmc: No
The purpose of the study is to measure the blood levels of the medicine called ropivacaine
      (local anesthetic) used to manage pain. Ropivacaine is a widely used medication and is not
      the subject of this study, but the investigators are studying how much of the drug can be
      found in the patient's blood, known as the blood level, of this medicine. Too much
      ropivacaine in a patient's blood can lead to local anesthetic toxicity. Once the nerve
      catheter is removed, local anesthetic toxicity is no longer a potential problem. However,
      there is little data on what ropivacaine blood levels are after having the catheter in for a
      long period of time(up to one month).
observational model: Cohort
time perspective: Prospective
measure: Plasma Ropivicaine Levels
time frame: up to 10 days
description: Blood will be drawn every 0, 3, 5, 7, and 10 days. Blood is drawn every 3 days thereafter.
The plasma ropivacaine samples will be assayed at the Department of Research Programs
      Laboratory (DRP) at WRNMMC. Once the whole blood sample has been centrifuged, the plasma will
      be removed with a glass pipette, placed in a storage container. The blood samples will be
      labeled with a non sequential serial number and will not include the time of the blood draw.
      This will blind the DRP laboratory to the patient's identity and timing of the blood draw.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor