<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/NCT01680913</url>
  </required_header>
  <id_info>
    <org_study_id>U/S spinals</org_study_id>
    <nct_id>NCT01680913</nct_id>
  </id_info>
  <brief_title>Does Ultrasound Guidance Improve Time to Perform a Spinal or Number of Attempts in Obese Patients?</brief_title>
  <official_title>Does Ultrasound Guidance Improve Time to Perform a Spinal or Number of Attempts in Obese Patients? A Randomized Controlled Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Saskatchewan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Spinal anesthesia depends on being able to locate physical landmarks on a patient's body. In&#xD;
      obese patients, the commonly used landmarks may be difficult or even impossible to feel. In&#xD;
      addition, the spine can be hidden beneath a layer of fatty tissue.&#xD;
&#xD;
      Ultrasound is useful for finding the correct injection site in pregnant patients, but the&#xD;
      usefulness of ultrasound has not been adequately evaluated in non-pregnant patients. The&#xD;
      potential benefits for obese patients from the use of ultrasound include shortening the&#xD;
      duration of the procedure, increasing patient comfort, decreasing the total number of&#xD;
      attempts, and aiding in the choice of appropriate needle length for the patient.&#xD;
&#xD;
      The investigators hypothesize that there is no difference in time to perform a spinal&#xD;
      anesthetic when landmarking with ultrasound as compared to tactile landmarking in patients&#xD;
      with BMI &gt; 35.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total time to perform the spinal</measure>
    <time_frame>From the beginning of palpation or ultrasound to free flow of Cerebral Spinal Fluid (CSF), up to 1 hour.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from administration of the local anesthetic needle until free flow CSF</measure>
    <time_frame>Up to 1 hour</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of needle redirections</measure>
    <time_frame>At time of spinal anesthetic administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of attempts to complete the spinal</measure>
    <time_frame>At time of spinal anesthetic administration</time_frame>
    <description>As measured by new needle puncture sites, according to the anesthetist performing the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of failed blocks</measure>
    <time_frame>Up to 15 minutes after administration of spinal anesthesia</time_frame>
    <description>Defined as unable to get free flow CSF or inadequate surgical block after administration of neuraxial anesthetic after 15 minutes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Spinal Anesthesia Administration</condition>
  <arm_group>
    <arm_group_label>Spinal with ultrasound guidance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spinal by palpation of Tuffier's line</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Current clinical practice. Standard of care would have the attending anesthetist palpate the Tuffier's line to pinpoint the appropriate location for the spinal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound guidance</intervention_name>
    <description>The intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views.</description>
    <arm_group_label>Spinal with ultrasound guidance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Palpation of Tuffier's line</intervention_name>
    <description>Current clinical practice. Standard of care would have the attending anesthetist palpate the Tuffier's line to pinpoint the appropriate location for the spinal.</description>
    <arm_group_label>Spinal by palpation of Tuffier's line</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spinal anesthetic</intervention_name>
    <description>Subcutaneous local infiltration with a 25g needle we be performed prior to the spinal. Neuraxial technique will be attempted midline with a 25 gauge whitacre needle in the sitting position. Spinals will be attempted on either L2-L3, L3-L4, L4-L5 interspaces. The amount and type of local anesthetic/intrathecal narcotic will be left to the discretion of the Anesthetist.</description>
    <arm_group_label>Spinal by palpation of Tuffier's line</arm_group_label>
    <arm_group_label>Spinal with ultrasound guidance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing surgeries amenable to spinal anesthetic&#xD;
&#xD;
          -  BMI &gt;35&#xD;
&#xD;
          -  between the ages of 18-85&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known spinal disease or previous spinal surgery&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Patients requiring emergent surgeries&#xD;
&#xD;
          -  Patients in positions other than sitting during neuroaxial anesthesia&#xD;
&#xD;
          -  Patients with contraindications to neuroaxial anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacelyn Larson, MD FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Saskatchewan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saskatoon City Hospital</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7K 0M7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Paul's Hospital</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7M 0Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>November 10, 2016</last_update_submitted>
  <last_update_submitted_qc>November 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Saskatchewan</investigator_affiliation>
    <investigator_full_name>Jacelyn Larson</investigator_full_name>
    <investigator_title>Faculty</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</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/NCT01680913
org study id: U/S spinals
nct id: NCT01680913
lead sponsor: 
has dmc: No
Spinal anesthesia depends on being able to locate physical landmarks on a patient's body. In
      obese patients, the commonly used landmarks may be difficult or even impossible to feel. In
      addition, the spine can be hidden beneath a layer of fatty tissue.

      Ultrasound is useful for finding the correct injection site in pregnant patients, but the
      usefulness of ultrasound has not been adequately evaluated in non-pregnant patients. The
      potential benefits for obese patients from the use of ultrasound include shortening the
      duration of the procedure, increasing patient comfort, decreasing the total number of
      attempts, and aiding in the choice of appropriate needle length for the patient.

      The investigators hypothesize that there is no difference in time to perform a spinal
      anesthetic when landmarking with ultrasound as compared to tactile landmarking in patients
      with BMI > 35.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Total time to perform the spinal
time frame: From the beginning of palpation or ultrasound to free flow of Cerebral Spinal Fluid (CSF), up to 1 hour.
measure: Time from administration of the local anesthetic needle until free flow CSF
time frame: Up to 1 hour
measure: Number of needle redirections
time frame: At time of spinal anesthetic administration
measure: Number of attempts to complete the spinal
time frame: At time of spinal anesthetic administration
description: As measured by new needle puncture sites, according to the anesthetist performing the procedure
measure: Number of failed blocks
time frame: Up to 15 minutes after administration of spinal anesthesia
description: Defined as unable to get free flow CSF or inadequate surgical block after administration of neuraxial anesthetic after 15 minutes.
arm group label: Spinal with ultrasound guidance
arm group type: Experimental
description: The intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views.
arm group label: Spinal by palpation of Tuffier's line
arm group type: Active Comparator
description: Current clinical practice. Standard of care would have the attending anesthetist palpate the Tuffier's line to pinpoint the appropriate location for the spinal.
intervention type: Procedure
intervention name: Ultrasound guidance
description: The intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views.
arm group label: Spinal with ultrasound guidance
intervention type: Procedure
intervention name: Palpation of Tuffier's line
description: Current clinical practice. Standard of care would have the attending anesthetist palpate the Tuffier's line to pinpoint the appropriate location for the spinal.
arm group label: Spinal by palpation of Tuffier's line
intervention type: Procedure
intervention name: Spinal anesthetic
description: Subcutaneous local infiltration with a 25g needle we be performed prior to the spinal. Neuraxial technique will be attempted midline with a 25 gauge whitacre needle in the sitting position. Spinals will be attempted on either L2-L3, L3-L4, L4-L5 interspaces. The amount and type of local anesthetic/intrathecal narcotic will be left to the discretion of the Anesthetist.
arm group label: Spinal by palpation of Tuffier's line
arm group label: Spinal with ultrasound guidance
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jacelyn Larson, MD FRCP
role: Principal Investigator
affiliation: University of Saskatchewan
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Saskatchewan
investigator full name: Jacelyn Larson
investigator title: Faculty
mesh term: Anesthetics