<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/NCT03022136</url>
  </required_header>
  <id_info>
    <org_study_id>Der-201701</org_study_id>
    <nct_id>NCT03022136</nct_id>
  </id_info>
  <brief_title>To Map Human Lower Thoracic Dermatomes by Epidural Block</brief_title>
  <acronym>LTDEP</acronym>
  <official_title>Observation Study of Thoracic Dermatomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Significant differences exist among various dermatome maps. In addition, there were no&#xD;
      anatomical landmarks to evaluate the dermatome at the back. The investigators aim to map the&#xD;
      sensory innervations of lower thoracic nerves and find the dorsal landmarks to evaluate&#xD;
      sensory innervations by epidural block. Patients undergoing urological surgery will receive&#xD;
      epidural block. Fifty patients with superior border of complete sensory loss to ice from T9&#xD;
      to T12 (anterior median line) will be included in this study. The sensory loss to ice will be&#xD;
      evaluated at midclavicular line, anterior axillary line, posterior axillary line, scapular&#xD;
      line and posterior median line. The level of vertebrae will be identified and marked by&#xD;
      ultrasound. The superior border of complete sensory loss to ice from anterior median line to&#xD;
      posterior median line will be recorded for every patient. The dermatome map of T9 to T12 will&#xD;
      be drawn. The landmarks of sensory innervations at posterior median line will be established&#xD;
      using vertebrae.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The tract for percutaneous nephrolithotomy is typically established in the 11th&#xD;
      intercostal space or in the subcostal area. According to Keegan and Garrett's dermatome map,&#xD;
      the somatic pain could be controlled if the 11th and 12th the spinal nerve been blocked.&#xD;
      However, the investigators found that if the 11th and the 12th spinal nerve had been blocked&#xD;
      by evaluating the landmarks of ventral landmarks (xiphoid process , umbilicus and pubic&#xD;
      symphysis), the somatic pain of percutaneous nephrolithotomy could not be controlled. In&#xD;
      order to find the reason, the investigators compared the four main dermatome maps created by&#xD;
      Henry Head, Foerster, Keegan and Lee. There are significant differences of dermatome among&#xD;
      these maps. In addition, there were no landmarks to evaluate the dermatome at the back.&#xD;
&#xD;
      Objectives: To map the sensory innervations of lower thoracic nerves and find the dorsal&#xD;
      landmarks to evaluate sensory innervations by epidural block.&#xD;
&#xD;
      Methods: Adult patients undergoing elective percutaneous nephrolithotomy, ureteroscopic&#xD;
      lithotripsy, transuretheral resection of prostate and transuretheral resection of bladder&#xD;
      tumor will receive epidural block with 0.5% ropivacaine. Complete Sensory loss to ice will be&#xD;
      evaluated at anterior median line as soon as the surgery was completed. The superior border&#xD;
      of complete sensory loss to ice will be identified by ventral landmaks (xiphoid process ,&#xD;
      umbilicus and pubic symphysis). Fifty patients with superior border of complete sensory loss&#xD;
      to ice from T9 to T12 will be included in this study. The sensory loss to ice will be&#xD;
      evaluated at anterior median line, midclavicular line, anterior axillary line, posterior&#xD;
      axillary line, scapular line and posterior median line. The level of vertebrae will be&#xD;
      identified and marked by ultrasound. The superior border of complete sensory loss to ice form&#xD;
      anterior median line to posterior median line will be drawn and recorded for every patient.&#xD;
      The dermatome map from T9 to T12 will be drawn. The landmarks of sensory innervations at&#xD;
      posterior median line will be established using vertebrae..&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2017</completion_date>
  <primary_completion_date type="Actual">July 1, 2017</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Superior border of sensory block was assessed by cold sensation method</measure>
    <time_frame>at the end of surgery</time_frame>
    <description>The sensory loss to ice will be evaluated at anterior median line, midclavicular line, anterior axillary line, posterior axillary line, scapular line and posterior median line. The level of vertebrae will be identified and marked by ultrasound. The upper border of complete sensory loss to ice form anterior median line to posterior median line will be drawn and recorded for every patient.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Urological Disease</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Epidural Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Epidural block for patients undergoing urological surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cold sensation method</intervention_name>
    <description>Complete sensory loss to ice will be evaluated form anterior median line to posterior median line at the end of surgery.</description>
    <arm_group_label>Epidural Block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for percutaneous nephtolithotomy, ureteroscopy lithotripsy,&#xD;
             transurethral resection of bladder tumor or transurethral resection of the prostate&#xD;
&#xD;
          -  American Society of Anesthesiologists physical statusⅠ-Ⅲ&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coagulopathy, on anticoagulants&#xD;
&#xD;
          -  History of surgery on spine&#xD;
&#xD;
          -  Spine deformity&#xD;
&#xD;
          -  A known allergy to the drugs being used&#xD;
&#xD;
          -  Tumer or infection at the site of puncture&#xD;
&#xD;
          -  refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yong Liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology,Tongji Hospital,Wuhan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tongji Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Head H, Campbell AW, Kennedy PG. The pathology of Herpes Zoster and its bearing on sensory localisation. Rev Med Virol. 1997 Sep;7(3):131-143. doi: 10.1002/(sici)1099-1654(199709)7:33.0.co;2-7. No abstract available.</citation>
    <PMID>10398478</PMID>
  </results_reference>
  <results_reference>
    <citation>Wolff AP, Wilder Smith OH, Crul BJ, van de Heijden MP, Groen GJ. Lumbar segmental nerve blocks with local anesthetics, pain relief, and motor function: a prospective double-blind study between lidocaine and ropivacaine. Anesth Analg. 2004 Aug;99(2):496-501, table of contents. doi: 10.1213/01.ANE.0000122268.70154.A9.</citation>
    <PMID>15271730</PMID>
  </results_reference>
  <results_reference>
    <citation>Greenberg SA. The history of dermatome mapping. Arch Neurol. 2003 Jan;60(1):126-31. doi: 10.1001/archneur.60.1.126.</citation>
    <PMID>12533100</PMID>
  </results_reference>
  <results_reference>
    <citation>Lee MW, McPhee RW, Stringer MD. An evidence-based approach to human dermatomes. Clin Anat. 2008 Jul;21(5):363-73. doi: 10.1002/ca.20636.</citation>
    <PMID>18470936</PMID>
  </results_reference>
  <results_reference>
    <citation>Downs MB, Laporte C. Conflicting dermatome maps: educational and clinical implications. J Orthop Sports Phys Ther. 2011 Jun;41(6):427-34. doi: 10.2519/jospt.2011.3506. Epub 2011 May 31.</citation>
    <PMID>21628826</PMID>
  </results_reference>
  <results_reference>
    <citation>Ladak A, Tubbs RS, Spinner RJ. Mapping sensory nerve communications between peripheral nerve territories. Clin Anat. 2014 Jul;27(5):681-90. doi: 10.1002/ca.22285. Epub 2013 Jul 3.</citation>
    <PMID>23824984</PMID>
  </results_reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>July 13, 2018</last_update_submitted>
  <last_update_submitted_qc>July 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji Hospital</investigator_affiliation>
    <investigator_full_name>Liu Yong</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>epidural block</keyword>
  <keyword>dermatome</keyword>
  <keyword>human</keyword>
  <keyword>spinal nerve</keyword>
  <keyword>thoracic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urologic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Damatomes of sensory loss to cold of each patient. Investigators can contact us by e-mail.</ipd_description>
  </patient_data>
  <!-- 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/NCT03022136
org study id: Der-201701
nct id: NCT03022136
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Significant differences exist among various dermatome maps. In addition, there were no
      anatomical landmarks to evaluate the dermatome at the back. The investigators aim to map the
      sensory innervations of lower thoracic nerves and find the dorsal landmarks to evaluate
      sensory innervations by epidural block. Patients undergoing urological surgery will receive
      epidural block. Fifty patients with superior border of complete sensory loss to ice from T9
      to T12 (anterior median line) will be included in this study. The sensory loss to ice will be
      evaluated at midclavicular line, anterior axillary line, posterior axillary line, scapular
      line and posterior median line. The level of vertebrae will be identified and marked by
      ultrasound. The superior border of complete sensory loss to ice from anterior median line to
      posterior median line will be recorded for every patient. The dermatome map of T9 to T12 will
      be drawn. The landmarks of sensory innervations at posterior median line will be established
      using vertebrae.
Background: The tract for percutaneous nephrolithotomy is typically established in the 11th
      intercostal space or in the subcostal area. According to Keegan and Garrett's dermatome map,
      the somatic pain could be controlled if the 11th and 12th the spinal nerve been blocked.
      However, the investigators found that if the 11th and the 12th spinal nerve had been blocked
      by evaluating the landmarks of ventral landmarks (xiphoid process , umbilicus and pubic
      symphysis), the somatic pain of percutaneous nephrolithotomy could not be controlled. In
      order to find the reason, the investigators compared the four main dermatome maps created by
      Henry Head, Foerster, Keegan and Lee. There are significant differences of dermatome among
      these maps. In addition, there were no landmarks to evaluate the dermatome at the back.

      Objectives: To map the sensory innervations of lower thoracic nerves and find the dorsal
      landmarks to evaluate sensory innervations by epidural block.

      Methods: Adult patients undergoing elective percutaneous nephrolithotomy, ureteroscopic
      lithotripsy, transuretheral resection of prostate and transuretheral resection of bladder
      tumor will receive epidural block with 0.5% ropivacaine. Complete Sensory loss to ice will be
      evaluated at anterior median line as soon as the surgery was completed. The superior border
      of complete sensory loss to ice will be identified by ventral landmaks (xiphoid process ,
      umbilicus and pubic symphysis). Fifty patients with superior border of complete sensory loss
      to ice from T9 to T12 will be included in this study. The sensory loss to ice will be
      evaluated at anterior median line, midclavicular line, anterior axillary line, posterior
      axillary line, scapular line and posterior median line. The level of vertebrae will be
      identified and marked by ultrasound. The superior border of complete sensory loss to ice form
      anterior median line to posterior median line will be drawn and recorded for every patient.
      The dermatome map from T9 to T12 will be drawn. The landmarks of sensory innervations at
      posterior median line will be established using vertebrae..
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Superior border of sensory block was assessed by cold sensation method
time frame: at the end of surgery
description: The sensory loss to ice will be evaluated at anterior median line, midclavicular line, anterior axillary line, posterior axillary line, scapular line and posterior median line. The level of vertebrae will be identified and marked by ultrasound. The upper border of complete sensory loss to ice form anterior median line to posterior median line will be drawn and recorded for every patient.
arm group label: Epidural Block
arm group type: Experimental
description: Epidural block for patients undergoing urological surgery
intervention type: Other
intervention name: cold sensation method
description: Complete sensory loss to ice will be evaluated form anterior median line to posterior median line at the end of surgery.
arm group label: Epidural Block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Yong Liu, MD
role: Principal Investigator
affiliation: Department of Anesthesiology,Tongji Hospital,Wuhan
facility: 
country: China
citation: Head H, Campbell AW, Kennedy PG. The pathology of Herpes Zoster and its bearing on sensory localisation. Rev Med Virol. 1997 Sep;7(3):131-143. doi: 10.1002/(sici)1099-1654(199709)7:33.0.co;2-7. No abstract available.
PMID: 10398478
citation: Wolff AP, Wilder Smith OH, Crul BJ, van de Heijden MP, Groen GJ. Lumbar segmental nerve blocks with local anesthetics, pain relief, and motor function: a prospective double-blind study between lidocaine and ropivacaine. Anesth Analg. 2004 Aug;99(2):496-501, table of contents. doi: 10.1213/01.ANE.0000122268.70154.A9.
PMID: 15271730
citation: Greenberg SA. The history of dermatome mapping. Arch Neurol. 2003 Jan;60(1):126-31. doi: 10.1001/archneur.60.1.126.
PMID: 12533100
citation: Lee MW, McPhee RW, Stringer MD. An evidence-based approach to human dermatomes. Clin Anat. 2008 Jul;21(5):363-73. doi: 10.1002/ca.20636.
PMID: 18470936
citation: Downs MB, Laporte C. Conflicting dermatome maps: educational and clinical implications. J Orthop Sports Phys Ther. 2011 Jun;41(6):427-34. doi: 10.2519/jospt.2011.3506. Epub 2011 May 31.
PMID: 21628826
citation: Ladak A, Tubbs RS, Spinner RJ. Mapping sensory nerve communications between peripheral nerve territories. Clin Anat. 2014 Jul;27(5):681-90. doi: 10.1002/ca.22285. Epub 2013 Jul 3.
PMID: 23824984
responsible party type: Principal Investigator
investigator affiliation: Tongji Hospital
investigator full name: Liu Yong
investigator title: Principal Investigator
mesh term: Urologic Diseases
sharing ipd: Yes
ipd description: Damatomes of sensory loss to cold of each patient. Investigators can contact us by e-mail.