<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/NCT04401007</url>
  </required_header>
  <id_info>
    <org_study_id>19-5863.0</org_study_id>
    <nct_id>NCT04401007</nct_id>
  </id_info>
  <brief_title>Erector Spinae Plane (ESP) Block Volunteer Study</brief_title>
  <official_title>A Volunteer Study to Determine the Anesthetic and Analgesic Effect of the Erector Spinae Plane (ESP) Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Although erector spinae plane (ESP) block reportedly provides postoperative pain relieve,&#xD;
      controversy remains regarding the accuracy and consistency of analgesic success following ESP&#xD;
      block. The goal of this study is to determine the extent and duration of clinical neural&#xD;
      blockade following an ESP injection with different local anesthetic doses.&#xD;
&#xD;
      Methods Twenty four healthy volunteers will be recruited, and each subject will make 2&#xD;
      separate visits to the study centre to undergo intervention and assessment. The 2 study&#xD;
      visits will be separated by an interval of at least 2 weeks to ensure complete washout of any&#xD;
      residual effects and a return to baseline status.&#xD;
&#xD;
      At each study visit, the subject will receive a unilateral ESP block with 1.5% lidocaine and&#xD;
      5 mcg/mL epinephrine. Two different local anesthetic volumes will be investigated: 20 mL (300&#xD;
      mg lidocaine) at one study visit and 30 mL (450 mg lidocaine) at the other study visit.&#xD;
      Volunteers will be randomized to one of two intervention groups: (1) Group 20/30: A&#xD;
      unilateral ESP block with 20 mL of local anesthetic at the first visit, and 30 mL of local&#xD;
      anesthetic at the second visit; or (2) Group 30/20: a unilateral ESP block with 30 mL of 1.5%&#xD;
      lidocaine with 1/200,000 epinephrine at the first visit, and 20 mL of the same local&#xD;
      anesthetic solution at the second visit.&#xD;
&#xD;
      There will be 2 study subgroups based on the vertebral level at which the ESP block is&#xD;
      administered: (1) Volunteer subjects in subgroup TP4 will receive the ESP block injection at&#xD;
      the T4 transverse process (TP4) level in order to evaluate the anesthetic effect on the chest&#xD;
      wall. (2) Volunteers in subgroup TP8 will receive the ESP block injection at the T8&#xD;
      transverse process (TP8) level in order to evaluate the anesthetic effect on the abdominal&#xD;
      wall. The first 10 volunteer subjects recruited will receive ESP blocks at the TP4 level and&#xD;
      the subsequent 10 subjects will receive ESP blocks at the TP8 level.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Erector spinae plane (ESP) block is a new regional nerve block technique that involves a&#xD;
      percutaneous injection of local anesthetic as a bolus through a needle or catheter into the&#xD;
      fascial plane between the erector spinae muscle and the transverse processes in the upper or&#xD;
      mid back. Injection at the level of the T4-5 transverse process is indicated for chest wall&#xD;
      pain relief while injection at the T8-9 level is for abdominal wall pain control. This block&#xD;
      aims to relieve postoperative pain but is not intended to provide anesthetic blockade for&#xD;
      surgery. Preliminary case reports and some randomized controlled trials show encouraging&#xD;
      analgesic effect of ESP block for breast surgery, rib fracture, thoracotomy, sternotomy,&#xD;
      epigastric hernia repair, open abdominal surgery, laparoscopic abdominal surgery, radical&#xD;
      retropubic prostatectomy and hip arthroplasty. Although effective, controversy remains&#xD;
      regarding the accuracy and consistency of analgesic success following ESP block.&#xD;
&#xD;
      Currently, it is unclear whether block inconsistency is due to improper injection technique&#xD;
      or the mechanism of action. Presumably, local anesthetic following an ESP block injection&#xD;
      will find its way antero-medially through the costotransverse foramen and / or inter&#xD;
      transverse ligaments to enter the thoracic paravertebral space or epidural space to block the&#xD;
      ventral rami of the thoracic spinal nerves. It may also spread laterally to reach the&#xD;
      neighbouring intercostal nerves.&#xD;
&#xD;
      At this time, it is unclear whether cadaver injection studies showing dye spread to these&#xD;
      anatomical spaces can fully explain the observed clinical neural blockade. Also a number of&#xD;
      cadaver studies show inconsistent and conflicting dye spread results, i.e., failure to reach&#xD;
      the thoracic paravertebral space. Although some suggest that an ESP block also provides&#xD;
      sympathetic blockade thus may provide visceral pain relief, no study has evaluated the&#xD;
      validity of such a claim or the extent of sympathetic blockade.&#xD;
&#xD;
      The mechanisms of action for an ESP block are currently unclear. Although most case reports&#xD;
      describe analgesic effects of ESP block for anterior chest and abdominal surgery presumably&#xD;
      as a result of blockade of the ventral rami of the spinal nerves in the thoracic&#xD;
      paravertebral spaces, it is more likely that local anesthetic injected in the ESP will&#xD;
      reliably anesthetize the dorsal rami traversing the erector spinae muscle in the back. This&#xD;
      is supported by preliminary clinical analgesic success of ESP block for thoracic spine&#xD;
      surgery and lumbar spine surgery. The consistency of blocking the ventral and dorsal rami&#xD;
      following an ESP block injection is unknown at this time.&#xD;
&#xD;
      Investigators' clinical experience further confirms that an ESP injection provides variable&#xD;
      analgesic results and an objective sign of sensory anesthesia to pinprick or ice is not&#xD;
      consistently evident. Currently no study has examined the optimal technique of ESP block&#xD;
      injection, peak blood local anesthetic level after injection, the effect of spine movement&#xD;
      (i.e., gliding movement of erector spinae muscle on the transverse processes) on neural&#xD;
      blockade, and the consistency of this block technique. Also, most case reports on surgical&#xD;
      patients did not report the onset, progression or resolution of ESP blockade or the extent of&#xD;
      sensory and sympathetic blockade. From a clinical perspective, it would be very helpful to&#xD;
      determine the extent and duration of clinical neural blockade following an ESP injection with&#xD;
      different local anesthetic doses and such detailed examination is possible only in a&#xD;
      carefully conducted volunteer study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</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>
    <intervention_model_description>There will be 2 study subgroups based on the vertebral level at which the ESP block is administered: (1) Volunteer subjects in subgroup TP4 will receive the ESP block injection at the T4 transverse process (TP4) level. Injection at the TP4 level will allow us to evaluate the anesthetic effect on the chest wall. (2) Volunteers in subgroup TP8 will receive the ESP block injection at the T8 transverse process (TP8) level. Injection at the TP8 level will allow us to evaluate the anesthetic effect on the abdominal wall.&#xD;
The first 12 volunteer subjects recruited will receive ESP blocks at the TP4 level and the subsequent 12 subjects will receive ESP blocks at the TP8 level.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Two different local anesthetic volumes will be investigated: 20 mL (300 mg lidocaine) at one study visit and 30 mL (450 mg lidocaine) at the other study visit. Volunteers will be randomized to one of two intervention groups: (1) Group 20/30: A unilateral ESP block with 20 mL of local anesthetic at the first visit, and 30 mL of local anesthetic at the second visit; or (2) Group 30/20: a unilateral ESP block with 30 mL of 1.5% lidocaine with 1/200,000 epinephrine at the first visit, and 20 mL of the same local anesthetic solution at the second visit. Randomization of subjects to either Group 20/30 or Group 30/20 will be done using computer software and only the study investigator performing the ESP block will be aware of the study allocation. Volunteer subjects and the study investigators responsible for serial neurologic and other outcome assessments after injection will be blinded to the volume of local anesthetic injected.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>the duration of sensory blockade Sensation to Pinprick of thoracic ventral rami</measure>
    <time_frame>up to 10 hours</time_frame>
    <description>duration of ESP block Sensation to Pinprick</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the duration of sensory blockade Sensation to Pinprick of thoracic dorsal rami</measure>
    <time_frame>up to 10 hours</time_frame>
    <description>duration of ESP block Sensation to Pinprick</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the duration of sensory blockade Sensation to temperature of thoracic ventral rami</measure>
    <time_frame>up to 10 hours</time_frame>
    <description>duration of ESP block Sensation to different temperature</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the duration of sensory blockade Sensation to temperature of thoracic dorsal rami</measure>
    <time_frame>up to 10 hours</time_frame>
    <description>duration of ESP block Sensation to different temperature</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the onset of pinprick blockade of an ESP block injection</measure>
    <time_frame>up to 2 hours</time_frame>
    <description>onset of ESP block on pinprick</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the onset of temperature blockade of an ESP block</measure>
    <time_frame>up to 2 hours</time_frame>
    <description>onset of ESP block on temperature</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the regression of pinprick blockade of an ESP block injection</measure>
    <time_frame>post-block 2-10 hours</time_frame>
    <description>regression of the ESP block on pinprick</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the regression of temperature blockade of an ESP block injection</measure>
    <time_frame>post-block 2-10 hours</time_frame>
    <description>regression of the ESP block on Skin Conductance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the success of blockade on Skin Conductance of an ESP block injection</measure>
    <time_frame>0-2 hours</time_frame>
    <description>post-block success of blockade on Skin Conductance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the onset of blockade on Skin Conductance of an ESP block injection</measure>
    <time_frame>post-block 0-2 hours</time_frame>
    <description>the onset of blockade on Skin Conductance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the regression of blockade on Skin Conductance of an ESP block injection</measure>
    <time_frame>post-block 2-10hours</time_frame>
    <description>the regression of blockade on Skin Conductance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Pain Management</condition>
  <arm_group>
    <arm_group_label>Group 20/30</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two different local anesthetic volumes will be investigated: 20 mL of 1.5% lidocaine (300 mg lidocaine) at one study visit and 30 mL of 1.5% lidocaine (450 mg lidocaine) at the other study visit. Volunteers will be randomized to one of two intervention groups: (1) Group 20/30: A unilateral ESP block with 20 mL of local anesthetic at the first visit, and 30 mL of local anesthetic at the second visit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 30/20</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>(2) Group 30/20: a unilateral ESP block with 30 mL of 1.5% lidocaine with 1/200,000 epinephrine at the first visit, and 20 mL of the same local anesthetic solution at the second visit. This crossover design allows subjects to serve as their own control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Erector Spinae Plane Block with 1.5% lidocaine</intervention_name>
    <description>Erector spinae plane (ESP) block is a new regional nerve block technique that involves a percutaneous injection of local anesthetic as a bolus through a needle or catheter into the fascial plane between the erector spinae muscle and the transverse processes in the upper or mid back.</description>
    <arm_group_label>Group 20/30</arm_group_label>
    <arm_group_label>Group 30/20</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA 1 (normal healthy) volunteers&#xD;
&#xD;
          -  18 - 50 years of age&#xD;
&#xD;
          -  65- 100 kg weight&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  female volunteers of childbearing potential will be required to provide a negative&#xD;
             pregnancy test before being allowed to participate, females of child bearing potential&#xD;
             must be willing to use medically acceptable birth control methods for a minimum of 2&#xD;
             weeks following the nerve block.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  weight &lt; 65 kg (limited by the maximum lidocaine dose 7 mg/kg)&#xD;
&#xD;
          -  medical disorders (including bleeding disorders)&#xD;
&#xD;
          -  any recreational drug use&#xD;
&#xD;
          -  allergy to local anesthetic (lidocaine, bupivacaine, ropivacaine)&#xD;
&#xD;
          -  contraindication to regional anesthetic block&#xD;
&#xD;
          -  inability to provide informed consent&#xD;
&#xD;
          -  baseline abnormality of chest, abdominal and back sensation&#xD;
&#xD;
          -  pregnancy / breast feeding&#xD;
&#xD;
          -  individuals with mental health disorders (for example bipolar disorder or depression).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincent Chan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rongyu ( Cindy) Jin</last_name>
    <phone>416-603-5800</phone>
    <phone_ext>2016</phone_ext>
    <email>rongyu.jin@uhn.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rongyu (Cindy) Jin</last_name>
    </contact>
    <investigator>
      <last_name>Vincent Chan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>March 17, 2021</last_update_submitted>
  <last_update_submitted_qc>March 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share IPD with other researchers</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/NCT04401007
org study id: 19-5863.0
nct id: NCT04401007
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Although erector spinae plane (ESP) block reportedly provides postoperative pain relieve,
      controversy remains regarding the accuracy and consistency of analgesic success following ESP
      block. The goal of this study is to determine the extent and duration of clinical neural
      blockade following an ESP injection with different local anesthetic doses.

      Methods Twenty four healthy volunteers will be recruited, and each subject will make 2
      separate visits to the study centre to undergo intervention and assessment. The 2 study
      visits will be separated by an interval of at least 2 weeks to ensure complete washout of any
      residual effects and a return to baseline status.

      At each study visit, the subject will receive a unilateral ESP block with 1.5% lidocaine and
      5 mcg/mL epinephrine. Two different local anesthetic volumes will be investigated: 20 mL (300
      mg lidocaine) at one study visit and 30 mL (450 mg lidocaine) at the other study visit.
      Volunteers will be randomized to one of two intervention groups: (1) Group 20/30: A
      unilateral ESP block with 20 mL of local anesthetic at the first visit, and 30 mL of local
      anesthetic at the second visit; or (2) Group 30/20: a unilateral ESP block with 30 mL of 1.5%
      lidocaine with 1/200,000 epinephrine at the first visit, and 20 mL of the same local
      anesthetic solution at the second visit.

      There will be 2 study subgroups based on the vertebral level at which the ESP block is
      administered: (1) Volunteer subjects in subgroup TP4 will receive the ESP block injection at
      the T4 transverse process (TP4) level in order to evaluate the anesthetic effect on the chest
      wall. (2) Volunteers in subgroup TP8 will receive the ESP block injection at the T8
      transverse process (TP8) level in order to evaluate the anesthetic effect on the abdominal
      wall. The first 10 volunteer subjects recruited will receive ESP blocks at the TP4 level and
      the subsequent 10 subjects will receive ESP blocks at the TP8 level.
Erector spinae plane (ESP) block is a new regional nerve block technique that involves a
      percutaneous injection of local anesthetic as a bolus through a needle or catheter into the
      fascial plane between the erector spinae muscle and the transverse processes in the upper or
      mid back. Injection at the level of the T4-5 transverse process is indicated for chest wall
      pain relief while injection at the T8-9 level is for abdominal wall pain control. This block
      aims to relieve postoperative pain but is not intended to provide anesthetic blockade for
      surgery. Preliminary case reports and some randomized controlled trials show encouraging
      analgesic effect of ESP block for breast surgery, rib fracture, thoracotomy, sternotomy,
      epigastric hernia repair, open abdominal surgery, laparoscopic abdominal surgery, radical
      retropubic prostatectomy and hip arthroplasty. Although effective, controversy remains
      regarding the accuracy and consistency of analgesic success following ESP block.

      Currently, it is unclear whether block inconsistency is due to improper injection technique
      or the mechanism of action. Presumably, local anesthetic following an ESP block injection
      will find its way antero-medially through the costotransverse foramen and / or inter
      transverse ligaments to enter the thoracic paravertebral space or epidural space to block the
      ventral rami of the thoracic spinal nerves. It may also spread laterally to reach the
      neighbouring intercostal nerves.

      At this time, it is unclear whether cadaver injection studies showing dye spread to these
      anatomical spaces can fully explain the observed clinical neural blockade. Also a number of
      cadaver studies show inconsistent and conflicting dye spread results, i.e., failure to reach
      the thoracic paravertebral space. Although some suggest that an ESP block also provides
      sympathetic blockade thus may provide visceral pain relief, no study has evaluated the
      validity of such a claim or the extent of sympathetic blockade.

      The mechanisms of action for an ESP block are currently unclear. Although most case reports
      describe analgesic effects of ESP block for anterior chest and abdominal surgery presumably
      as a result of blockade of the ventral rami of the spinal nerves in the thoracic
      paravertebral spaces, it is more likely that local anesthetic injected in the ESP will
      reliably anesthetize the dorsal rami traversing the erector spinae muscle in the back. This
      is supported by preliminary clinical analgesic success of ESP block for thoracic spine
      surgery and lumbar spine surgery. The consistency of blocking the ventral and dorsal rami
      following an ESP block injection is unknown at this time.

      Investigators' clinical experience further confirms that an ESP injection provides variable
      analgesic results and an objective sign of sensory anesthesia to pinprick or ice is not
      consistently evident. Currently no study has examined the optimal technique of ESP block
      injection, peak blood local anesthetic level after injection, the effect of spine movement
      (i.e., gliding movement of erector spinae muscle on the transverse processes) on neural
      blockade, and the consistency of this block technique. Also, most case reports on surgical
      patients did not report the onset, progression or resolution of ESP blockade or the extent of
      sensory and sympathetic blockade. From a clinical perspective, it would be very helpful to
      determine the extent and duration of clinical neural blockade following an ESP injection with
      different local anesthetic doses and such detailed examination is possible only in a
      carefully conducted volunteer study.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: There will be 2 study subgroups based on the vertebral level at which the ESP block is administered: (1) Volunteer subjects in subgroup TP4 will receive the ESP block injection at the T4 transverse process (TP4) level. Injection at the TP4 level will allow us to evaluate the anesthetic effect on the chest wall. (2) Volunteers in subgroup TP8 will receive the ESP block injection at the T8 transverse process (TP8) level. Injection at the TP8 level will allow us to evaluate the anesthetic effect on the abdominal wall.
The first 12 volunteer subjects recruited will receive ESP blocks at the TP4 level and the subsequent 12 subjects will receive ESP blocks at the TP8 level.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Two different local anesthetic volumes will be investigated: 20 mL (300 mg lidocaine) at one study visit and 30 mL (450 mg lidocaine) at the other study visit. Volunteers will be randomized to one of two intervention groups: (1) Group 20/30: A unilateral ESP block with 20 mL of local anesthetic at the first visit, and 30 mL of local anesthetic at the second visit; or (2) Group 30/20: a unilateral ESP block with 30 mL of 1.5% lidocaine with 1/200,000 epinephrine at the first visit, and 20 mL of the same local anesthetic solution at the second visit. Randomization of subjects to either Group 20/30 or Group 30/20 will be done using computer software and only the study investigator performing the ESP block will be aware of the study allocation. Volunteer subjects and the study investigators responsible for serial neurologic and other outcome assessments after injection will be blinded to the volume of local anesthetic injected.
measure: the duration of sensory blockade Sensation to Pinprick of thoracic ventral rami
time frame: up to 10 hours
description: duration of ESP block Sensation to Pinprick
measure: the duration of sensory blockade Sensation to Pinprick of thoracic dorsal rami
time frame: up to 10 hours
description: duration of ESP block Sensation to Pinprick
measure: the duration of sensory blockade Sensation to temperature of thoracic ventral rami
time frame: up to 10 hours
description: duration of ESP block Sensation to different temperature
measure: the duration of sensory blockade Sensation to temperature of thoracic dorsal rami
time frame: up to 10 hours
description: duration of ESP block Sensation to different temperature
measure: To evaluate the onset of pinprick blockade of an ESP block injection
time frame: up to 2 hours
description: onset of ESP block on pinprick
measure: To evaluate the onset of temperature blockade of an ESP block
time frame: up to 2 hours
description: onset of ESP block on temperature
measure: To evaluate the regression of pinprick blockade of an ESP block injection
time frame: post-block 2-10 hours
description: regression of the ESP block on pinprick
measure: To evaluate the regression of temperature blockade of an ESP block injection
time frame: post-block 2-10 hours
description: regression of the ESP block on Skin Conductance
measure: To evaluate the success of blockade on Skin Conductance of an ESP block injection
time frame: 0-2 hours
description: post-block success of blockade on Skin Conductance
measure: To evaluate the onset of blockade on Skin Conductance of an ESP block injection
time frame: post-block 0-2 hours
description: the onset of blockade on Skin Conductance
measure: To evaluate the regression of blockade on Skin Conductance of an ESP block injection
time frame: post-block 2-10hours
description: the regression of blockade on Skin Conductance
arm group label: Group 20/30
arm group type: Experimental
description: Two different local anesthetic volumes will be investigated: 20 mL of 1.5% lidocaine (300 mg lidocaine) at one study visit and 30 mL of 1.5% lidocaine (450 mg lidocaine) at the other study visit. Volunteers will be randomized to one of two intervention groups: (1) Group 20/30: A unilateral ESP block with 20 mL of local anesthetic at the first visit, and 30 mL of local anesthetic at the second visit
arm group label: Group 30/20
arm group type: Experimental
description: (2) Group 30/20: a unilateral ESP block with 30 mL of 1.5% lidocaine with 1/200,000 epinephrine at the first visit, and 20 mL of the same local anesthetic solution at the second visit. This crossover design allows subjects to serve as their own control.
intervention type: Other
intervention name: Erector Spinae Plane Block with 1.5% lidocaine
description: Erector spinae plane (ESP) block is a new regional nerve block technique that involves a percutaneous injection of local anesthetic as a bolus through a needle or catheter into the fascial plane between the erector spinae muscle and the transverse processes in the upper or mid back.
arm group label: Group 20/30
arm group label: Group 30/20
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vincent Chan, MD
role: Principal Investigator
affiliation: University Health Network, Toronto
last name: Rongyu ( Cindy) Jin
phone: 416-603-5800
phone ext: 2016
email: rongyu.jin@uhn.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Lidocaine
sharing ipd: No
ipd description: No plan to share IPD with other researchers