<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/NCT02989896</url>
  </required_header>
  <id_info>
    <org_study_id>ERZINCAN UNIVERSITY 5</org_study_id>
    <nct_id>NCT02989896</nct_id>
  </id_info>
  <brief_title>Perfusion Index in the Success of Peripheral Nerve Block</brief_title>
  <official_title>Evaluation of Perfusion Index in the Success of Peripheral Nerve Block in Advanced Age Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erzincan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erzincan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      After a successful peripheral nerve block, blockade of sympathetic nerve fibers results in&#xD;
      local vasodilatation, increased local blood flow, and increased skin temperature.Increased&#xD;
      permeability index; Can be used as a reliable tool for evaluating block activity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</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>patient's perfusion index</measure>
    <time_frame>nine month</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Perfusion Index</condition>
  <condition>Peripheral Nerve Block Success</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>perfusion index</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Elective orthopedic lower extremity surgery patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 65 years old&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 65 years old&#xD;
&#xD;
          -  Patients contraindicated in regional anesthesia&#xD;
&#xD;
          -  Patients with local anesthetic allergy&#xD;
&#xD;
          -  Patients with injection site infection&#xD;
&#xD;
          -  Patients who do not accept the procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Curatolo M, Petersen-Felix S, Arendt-Nielsen L. Sensory assessment of regional analgesia in humans: a review of methods and applications. Anesthesiology. 2000 Dec;93(6):1517-30. doi: 10.1097/00000542-200012000-00025. No abstract available.</citation>
    <PMID>11149448</PMID>
  </reference>
  <reference>
    <citation>Pearson AC, Gudipati CV, Labovitz AJ. Effects of aging on left ventricular structure and function. Am Heart J. 1991 Mar;121(3 Pt 1):871-5. doi: 10.1016/0002-8703(91)90201-r.</citation>
    <PMID>1825740</PMID>
  </reference>
  <reference>
    <citation>Lima AP, Beelen P, Bakker J. Use of a peripheral perfusion index derived from the pulse oximetry signal as a noninvasive indicator of perfusion. Crit Care Med. 2002 Jun;30(6):1210-3. doi: 10.1097/00003246-200206000-00006.</citation>
    <PMID>12072670</PMID>
  </reference>
  <reference>
    <citation>Kus A, Gurkan Y, Gormus SK, Solak M, Toker K. Usefulness of perfusion index to detect the effect of brachial plexus block. J Clin Monit Comput. 2013 Jun;27(3):325-8. doi: 10.1007/s10877-013-9439-4. Epub 2013 Feb 10.</citation>
    <PMID>23397432</PMID>
  </reference>
  <reference>
    <citation>Galvin EM, Niehof S, Verbrugge SJ, Maissan I, Jahn A, Klein J, van Bommel J. Peripheral flow index is a reliable and early indicator of regional block success. Anesth Analg. 2006 Jul;103(1):239-43, table of contents. doi: 10.1213/01.ane.0000220947.02689.9f.</citation>
    <PMID>16790660</PMID>
  </reference>
  <reference>
    <citation>Sebastiani A, Philippi L, Boehme S, Closhen D, Schmidtmann I, Scherhag A, Markstaller K, Engelhard K, Pestel G. Perfusion index and plethysmographic variability index in patients with interscalene nerve catheters. Can J Anaesth. 2012 Dec;59(12):1095-101. doi: 10.1007/s12630-012-9796-3. Epub 2012 Oct 2.</citation>
    <PMID>23055034</PMID>
  </reference>
  <reference>
    <citation>Goldman JM, Petterson MT, Kopotic RJ, Barker SJ. Masimo signal extraction pulse oximetry. J Clin Monit Comput. 2000;16(7):475-83. doi: 10.1023/a:1011493521730.</citation>
    <PMID>12580205</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>December 8, 2016</last_update_submitted>
  <last_update_submitted_qc>December 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erzincan University</investigator_affiliation>
    <investigator_full_name>ILKE KUPELI</investigator_full_name>
    <investigator_title>assist. prof.</investigator_title>
  </responsible_party>
  <keyword>Perfusion index</keyword>
  <keyword>Peripheral nerve block success</keyword>
  <keyword>older age</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/NCT02989896
org study id: ERZINCAN UNIVERSITY 5
nct id: NCT02989896
lead sponsor: 
has dmc: No
After a successful peripheral nerve block, blockade of sympathetic nerve fibers results in
      local vasodilatation, increased local blood flow, and increased skin temperature.Increased
      permeability index; Can be used as a reliable tool for evaluating block activity.
observational model: Cohort
time perspective: Prospective
measure: patient's perfusion index
time frame: nine month
intervention type: Device
intervention name: perfusion index
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
citation: Curatolo M, Petersen-Felix S, Arendt-Nielsen L. Sensory assessment of regional analgesia in humans: a review of methods and applications. Anesthesiology. 2000 Dec;93(6):1517-30. doi: 10.1097/00000542-200012000-00025. No abstract available.
PMID: 11149448
citation: Pearson AC, Gudipati CV, Labovitz AJ. Effects of aging on left ventricular structure and function. Am Heart J. 1991 Mar;121(3 Pt 1):871-5. doi: 10.1016/0002-8703(91)90201-r.
PMID: 1825740
citation: Lima AP, Beelen P, Bakker J. Use of a peripheral perfusion index derived from the pulse oximetry signal as a noninvasive indicator of perfusion. Crit Care Med. 2002 Jun;30(6):1210-3. doi: 10.1097/00003246-200206000-00006.
PMID: 12072670
citation: Kus A, Gurkan Y, Gormus SK, Solak M, Toker K. Usefulness of perfusion index to detect the effect of brachial plexus block. J Clin Monit Comput. 2013 Jun;27(3):325-8. doi: 10.1007/s10877-013-9439-4. Epub 2013 Feb 10.
PMID: 23397432
citation: Galvin EM, Niehof S, Verbrugge SJ, Maissan I, Jahn A, Klein J, van Bommel J. Peripheral flow index is a reliable and early indicator of regional block success. Anesth Analg. 2006 Jul;103(1):239-43, table of contents. doi: 10.1213/01.ane.0000220947.02689.9f.
PMID: 16790660
citation: Sebastiani A, Philippi L, Boehme S, Closhen D, Schmidtmann I, Scherhag A, Markstaller K, Engelhard K, Pestel G. Perfusion index and plethysmographic variability index in patients with interscalene nerve catheters. Can J Anaesth. 2012 Dec;59(12):1095-101. doi: 10.1007/s12630-012-9796-3. Epub 2012 Oct 2.
PMID: 23055034
citation: Goldman JM, Petterson MT, Kopotic RJ, Barker SJ. Masimo signal extraction pulse oximetry. J Clin Monit Comput. 2000;16(7):475-83. doi: 10.1023/a:1011493521730.
PMID: 12580205
responsible party type: Principal Investigator
investigator affiliation: Erzincan University
investigator full name: ILKE KUPELI
investigator title: assist. prof.