<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/NCT01669018</url>
  </required_header>
  <id_info>
    <org_study_id>SSPS-1-10-72-366-12</org_study_id>
    <nct_id>NCT01669018</nct_id>
  </id_info>
  <brief_title>Ultrasound Guided Blockade of the Lumbar Plexus - the Supra Sacral Parallel Shift</brief_title>
  <acronym>SSPS</acronym>
  <official_title>The Supra Sacral Parallel Shift (SSPS) - Ultrasound Guided Blockade of the Lumbar Plexus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anesthesia for hip surgery can be performed with ultrasound guided blockade of the mesh of&#xD;
      nerves (the lumbar plexus) supplying the hip region from the lumbar spinal nerves. This is a&#xD;
      relevant technique in patients with severe cardiac comorbidity. The technique is a safer&#xD;
      alternative compared to general or spinal anesthesia in these fragile patients.&#xD;
&#xD;
      The most recognized technique with ultrasound guidance (Karmakars technique) is technically&#xD;
      demanding and based on injection of local anesthetic relatively close to the exit of the&#xD;
      spinal nerves from the spine. The risk is spread of local anesthetic to the spinal canal&#xD;
      prompting a risk of low blood pressure. This may be fatal in high risk patients.&#xD;
&#xD;
      The investigators have developed a simple technique based on injection away from the spinal&#xD;
      canal. The investigators expect minimal risk of spread of local anesthetic to the spinal&#xD;
      canal with this technique.&#xD;
&#xD;
      This randomized, double blinded trial compares the new technique to the established technique&#xD;
      of ultrasound guided blockade of the lumbar plexus.&#xD;
&#xD;
      The hypothesis is that the new technique has a higher success rate with reduced effect on&#xD;
      blood pressure for ultrasound guided lumbar plexus block compared to the established&#xD;
      technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success of complete sensory blockade of dermatomes L2, L3, L4, L5, S1</measure>
    <time_frame>30 minutes after injection of local anesthetic</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma lidocaine level (mcg/mL)</measure>
    <time_frame>0, 5, 10, 20, 40, 60, and 90 minutes after injection of local anesthetic</time_frame>
    <description>Chromatography analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Block performance time</measure>
    <time_frame>From start of probe on the skin until injection of local anesthetic is completed</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Immediately after completion of injection of local anesthetic</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean arterial blood pressure (MAP)</measure>
    <time_frame>5 minutes after completion of injection of local anesthetic</time_frame>
    <description>Absolute measure and relative change from pre-block measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>Block performance time period</time_frame>
    <description>Estimated as incremental cost-effectiveness ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensory blockade of each dermatome L1, L2, L3, L4, L5, S1, S2, and S3 (cold, warmth, touch, pain)</measure>
    <time_frame>30 minutes after completed injection of local anesthetic</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensory blockade of the femoral nerve (cold, warmth, touch, pain)</measure>
    <time_frame>30 minutes after completion of injection of local anesthetic</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor blockade of the femoral nerve</measure>
    <time_frame>40 minutes after completion of injection of the local anesthetic</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor blockade of the obturator nerve</measure>
    <time_frame>40 minutes after completion of injection of the local anesthetic</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perineural spread of local anesthetic (with contrast) estimated with MRI</measure>
    <time_frame>60 minutes after completion of injection of local anesthetic</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hip Fracture</condition>
  <arm_group>
    <arm_group_label>Lumbar ultrasound trident (LUT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lumbar plexus block using LUT technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supra Sacral Parallel Shift (SSPS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lumbar plexus block using SSPS technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lumbar plexus block using LUT technique</intervention_name>
    <description>Lumbar plexus block guided by ultrasound and nerve stimulation with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse processes of L3 and L4 until an appropriate neuromuscular response is produced.</description>
    <arm_group_label>Lumbar ultrasound trident (LUT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lumbar plexus block using SSPS technique</intervention_name>
    <description>Lumbar plexus block guided by ultrasound and loss of resistance (LOR) with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse process of L5 and the sacral bone until an appropriate LOR is produced.</description>
    <arm_group_label>Supra Sacral Parallel Shift (SSPS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  ASA I (American Society of Anesthesiologists physical status classification)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  volunteers who are not able to cooperate&#xD;
&#xD;
          -  volunteers who do not understand and speak danish&#xD;
&#xD;
          -  daily use of analgesics&#xD;
&#xD;
          -  allergy to local analgesics or contrast agents&#xD;
&#xD;
          -  abuse of medicine or alcohol&#xD;
&#xD;
          -  volunteers with technical impediments of the planned interventions&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Else Tønnesen, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Health, Aarhus University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology, Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>January 30, 2013</last_update_submitted>
  <last_update_submitted_qc>January 30, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Aarhus</investigator_affiliation>
    <investigator_full_name>Thomas F. Bendtsen</investigator_full_name>
    <investigator_title>Consultant anesthetist, associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hip Fractures</mesh_term>
  </condition_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/NCT01669018
org study id: SSPS-1-10-72-366-12
nct id: NCT01669018
lead sponsor: 
has dmc: No
Anesthesia for hip surgery can be performed with ultrasound guided blockade of the mesh of
      nerves (the lumbar plexus) supplying the hip region from the lumbar spinal nerves. This is a
      relevant technique in patients with severe cardiac comorbidity. The technique is a safer
      alternative compared to general or spinal anesthesia in these fragile patients.

      The most recognized technique with ultrasound guidance (Karmakars technique) is technically
      demanding and based on injection of local anesthetic relatively close to the exit of the
      spinal nerves from the spine. The risk is spread of local anesthetic to the spinal canal
      prompting a risk of low blood pressure. This may be fatal in high risk patients.

      The investigators have developed a simple technique based on injection away from the spinal
      canal. The investigators expect minimal risk of spread of local anesthetic to the spinal
      canal with this technique.

      This randomized, double blinded trial compares the new technique to the established technique
      of ultrasound guided blockade of the lumbar plexus.

      The hypothesis is that the new technique has a higher success rate with reduced effect on
      blood pressure for ultrasound guided lumbar plexus block compared to the established
      technique.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Success of complete sensory blockade of dermatomes L2, L3, L4, L5, S1
time frame: 30 minutes after injection of local anesthetic
measure: Plasma lidocaine level (mcg/mL)
time frame: 0, 5, 10, 20, 40, 60, and 90 minutes after injection of local anesthetic
description: Chromatography analysis
measure: Block performance time
time frame: From start of probe on the skin until injection of local anesthetic is completed
measure: Patient satisfaction
time frame: Immediately after completion of injection of local anesthetic
measure: Mean arterial blood pressure (MAP)
time frame: 5 minutes after completion of injection of local anesthetic
description: Absolute measure and relative change from pre-block measure
measure: Cost-effectiveness
time frame: Block performance time period
description: Estimated as incremental cost-effectiveness ratio
measure: Sensory blockade of each dermatome L1, L2, L3, L4, L5, S1, S2, and S3 (cold, warmth, touch, pain)
time frame: 30 minutes after completed injection of local anesthetic
measure: Sensory blockade of the femoral nerve (cold, warmth, touch, pain)
time frame: 30 minutes after completion of injection of local anesthetic
measure: Motor blockade of the femoral nerve
time frame: 40 minutes after completion of injection of the local anesthetic
measure: Motor blockade of the obturator nerve
time frame: 40 minutes after completion of injection of the local anesthetic
measure: Perineural spread of local anesthetic (with contrast) estimated with MRI
time frame: 60 minutes after completion of injection of local anesthetic
arm group label: Lumbar ultrasound trident (LUT)
arm group type: Active Comparator
description: Lumbar plexus block using LUT technique
arm group label: Supra Sacral Parallel Shift (SSPS)
arm group type: Experimental
description: Lumbar plexus block using SSPS technique
intervention type: Procedure
intervention name: Lumbar plexus block using LUT technique
description: Lumbar plexus block guided by ultrasound and nerve stimulation with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse processes of L3 and L4 until an appropriate neuromuscular response is produced.
arm group label: Lumbar ultrasound trident (LUT)
intervention type: Procedure
intervention name: Lumbar plexus block using SSPS technique
description: Lumbar plexus block guided by ultrasound and loss of resistance (LOR) with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse process of L5 and the sacral bone until an appropriate LOR is produced.
arm group label: Supra Sacral Parallel Shift (SSPS)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Else Tønnesen, Professor
role: Study Chair
affiliation: Faculty of Health, Aarhus University
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Aarhus
investigator full name: Thomas F. Bendtsen
investigator title: Consultant anesthetist, associate professor
mesh term: Hip Fractures