<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/NCT02255591</url>
  </required_header>
  <id_info>
    <org_study_id>AUH-TFB-SR</org_study_id>
    <secondary_id>2013-005346-10</secondary_id>
    <nct_id>NCT02255591</nct_id>
  </id_info>
  <brief_title>Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus</brief_title>
  <official_title>Shamrock Versus Lumbar Ultrasound Trident - Ultrasound Guided Block of the Lumbar Plexus: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AP Moeller Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of the trial is to complete a double-blinded randomized controlled trial&#xD;
      of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident&#xD;
      technique by estimating the time of performance of lumbar plexus blocks in healthy&#xD;
      volunteers.&#xD;
&#xD;
      Secondary objectives include a) estimates of number and depth of needle injections, distance&#xD;
      of injection site from the midline, minimal electric nerve stimulation to trigger muscular&#xD;
      response and the type of response, and volunteer discomfort during block injection, b)&#xD;
      measurements of plasma lidocaine and mean arterial blood pressure, c) examinations of sensory&#xD;
      block of the dermatomes T8-S3 and motor block of the femoral nerve, the obturator nerve, the&#xD;
      hip abductor muscles, and the hamstring muscles, d) success rate of lumbar plexus block, e)&#xD;
      perineural and epidural distribution of local anesthetics added contrast visualized on&#xD;
      magnetic resonance imaging (MRI) scanning, and f) cost-effectiveness for the Shamrock&#xD;
      technique versus the Lumbar Ultrasound Trident Technique for lumbar plexus block in healthy&#xD;
      volunteers.&#xD;
&#xD;
      The hypothesis is that the Shamrock technique is faster to perform than the Lumbar Ultrasound&#xD;
      technique, and that the success rate of the Shamrock technique is equal to or higher than the&#xD;
      Lumbar Ultrasound Trident technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 4</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>Block performance time</measure>
    <time_frame>Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.</time_frame>
    <description>Time for performance of lumbar plexus block in seconds from placement of the ultrasound transducer on the skin until the block needle is pulled out after injection of local anesthetics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of needle feeds</measure>
    <time_frame>Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.</time_frame>
    <description>Needle feeds are defined as retraction of needle followed by new feed of the needle disregarding the number of skin punctures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discomfort during block placement</measure>
    <time_frame>Estimated 1 minute after block placement. Presented 10 months after the last visit of the last volunteer.</time_frame>
    <description>Discomfort is measured with Numeric Rating Scale (NRS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Lidocaine</measure>
    <time_frame>Blood samples are withdrawn 0, 5, 10, 20, 40, 60, and 90 minutes after block placement. Presented 10 months after the last visit of the last volunteer.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mear arterial pressure</measure>
    <time_frame>Measured 5 minutes after block placement. Presented 10 months after the last visit of the last volunteer.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>Calculated two weeks after the last visit of the last volunteer. Presented 10 months after the last visit of the last volunteer.</time_frame>
    <description>Cost-effectiveness estimated as extra expense per successful lumbar plexus block and calculated as incremental cost-effectiveness ratio (ICER).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensor block</measure>
    <time_frame>Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.</time_frame>
    <description>Sensor block (cold, warm, touch, and pain) of the dermatomes T8-S3 and of the femoral nerve and the lateral femoral cutaneous nerve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor block</measure>
    <time_frame>Tested 40 minutes after block placement. Presented 10 months after the last visit of the last volunteer.</time_frame>
    <description>Motor block of the femoral nerve (knee extension), the obturator nerve (hip adduction), the superior gluteal nerve (hip abduction), and the sciatic nerve (knee flexion) estimated as active resistance against movement of the relevant joint and with sphygmomanometer of the relevant joint as maximal voluntary isometric contraction with dynamometer (mmHg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Block success rate</measure>
    <time_frame>Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.</time_frame>
    <description>Success rate defined as motor block of the femoral nerve (knee extension) and the obturator nerve (hip adduction) and reduced sensory of the lateral femoral cutaneous nerve (middle of the lateral side of the thigh).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Block success rate</measure>
    <time_frame>Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.</time_frame>
    <description>Defined as above after lumbar plexus block with the Shamrock technique for motor response on electrical nerve stimulation above respectively below 0,5 milliampere (mA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epidural spread of local anesthetics with contrast</measure>
    <time_frame>Estimated 10-30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.</time_frame>
    <description>Estimated with T1- and T2-weighted and with diffusion weighted imaging (DWI) MR scanning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perineural spread of local anesthetics with added contrast</measure>
    <time_frame>Estimated 10-30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.</time_frame>
    <description>Estimated with T1- and T2-weighted and with DWI MR scanning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depth of block needle</measure>
    <time_frame>Estimated during block</time_frame>
    <description>The depth in cm from the injection site in the skin to the needle tips position during injection. of local anesthetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Injection site</measure>
    <time_frame>Estimated immediately after block placement</time_frame>
    <description>The distance in cm from the injection site of the block needle to the midline of the volunteer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimal electrical nerve stimulation</measure>
    <time_frame>Estimated immediately before injection of local anesthetics during block placement</time_frame>
    <description>The estimated minimal electrical nerve stimulation in mA to trigger a muscular response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of response on electrical nerve stimulation</measure>
    <time_frame>Assessed immediately before injection of local anesthetics during block placement</time_frame>
    <description>The type of response triggered by electrical nerve stimulation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hip Fractures</condition>
  <condition>Anesthesia Local</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Shamrock</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of the Shamrock technique to place a lumbar plexus block with injection of 20 mL 2% Lidocaine-adrenaline added gadolinium.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lumbar Ultrasound Trident</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of the Lumbar Ultrasound Trident technique to place a lumbar plexus block with injection of 20 mL 2% lidocaine-adrenaline added gadolinium.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine-adrenaline added gadolinium.</intervention_name>
    <arm_group_label>Lumbar Ultrasound Trident</arm_group_label>
    <arm_group_label>Shamrock</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Volunteers who have given their written and oral consent to participate in the study&#xD;
             after fully understanding the content and the limitations of the protocol&#xD;
&#xD;
          -  Normal healthy volunteer (American Society of Anesthesiology (ASA) Classification I)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteers not able to cooperate for the study&#xD;
&#xD;
          -  Volunteers not able to understand Danish&#xD;
&#xD;
          -  Daily use of analgesics&#xD;
&#xD;
          -  Allergy against the medicines used in the study&#xD;
&#xD;
          -  Drug abuse (according to the investigator's judgement)&#xD;
&#xD;
          -  Alcohol consumption larger than the recommendations of the Danish National Board of&#xD;
             Health&#xD;
&#xD;
          -  Volunteers in whom nerve blocks are not possible due to technical reasons&#xD;
&#xD;
          -  Volunteers who meet any contraindication for MRI including claustrophobia&#xD;
&#xD;
          -  Volunteers who are incompetent, i.e. surrogate consent is not accepted&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas F Bendtsen, MD,PhD,Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Noerrebrogade 44, DK-8000 Aarhus C, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Aneshtesiology and Intensive Care Medicine; Aarhus University Hospital</name>
      <address>
        <city>Aarhus C</city>
        <zip>DK-8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>de Visme V, Picart F, Le Jouan R, Legrand A, Savry C, Morin V. Combined lumbar and sacral plexus block compared with plain bupivacaine spinal anesthesia for hip fractures in the elderly. Reg Anesth Pain Med. 2000 Mar-Apr;25(2):158-62. doi: 10.1053/rapm.2000.0250158.</citation>
    <PMID>10746528</PMID>
  </reference>
  <reference>
    <citation>Kirchmair L, Entner T, Kapral S, Mitterschiffthaler G. Ultrasound guidance for the psoas compartment block: an imaging study. Anesth Analg. 2002 Mar;94(3):706-10; table of contents. doi: 10.1097/00000539-200203000-00042.</citation>
    <PMID>11867402</PMID>
  </reference>
  <reference>
    <citation>Kirchmair L, Entner T, Wissel J, Moriggl B, Kapral S, Mitterschiffthaler G. A study of the paravertebral anatomy for ultrasound-guided posterior lumbar plexus block. Anesth Analg. 2001 Aug;93(2):477-81, 4th contents page. doi: 10.1097/00000539-200108000-00047.</citation>
    <PMID>11473883</PMID>
  </reference>
  <reference>
    <citation>Morimoto M, Kim JT, Popovic J, Jain S, Bekker A. Ultrasound-guided lumbar plexus block for open reduction and internal fixation of hip fracture. Pain Pract. 2006 Jun;6(2):124-6. doi: 10.1111/j.1533-2500.2006.00074.x.</citation>
    <PMID>17309721</PMID>
  </reference>
  <reference>
    <citation>Doi K, Sakura S, Hara K. A modified posterior approach to lumbar plexus block using a transverse ultrasound image and an approach from the lateral border of the transducer. Anaesth Intensive Care. 2010 Jan;38(1):213-4. No abstract available.</citation>
    <PMID>20191806</PMID>
  </reference>
  <reference>
    <citation>Madison SJ, Ilfeld BM, Loland VJ, Mariano ER. Posterior lumbar plexus perineural catheter insertion by ultrasound guidance alone. Acta Anaesthesiol Scand. 2011 Sep;55(8):1031-2. doi: 10.1111/j.1399-6576.2011.02489.x. Epub 2011 Jul 20. No abstract available.</citation>
    <PMID>21770905</PMID>
  </reference>
  <reference>
    <citation>Karmakar MK, Ho AM, Li X, Kwok WH, Tsang K, Ngan Kee WD. Ultrasound-guided lumbar plexus block through the acoustic window of the lumbar ultrasound trident. Br J Anaesth. 2008 Apr;100(4):533-7. doi: 10.1093/bja/aen026.</citation>
    <PMID>18344573</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>April 30, 2015</last_update_submitted>
  <last_update_submitted_qc>April 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hip surgery anesthesia</keyword>
  <keyword>Perioperative analgesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Racepinephrine</mesh_term>
    <mesh_term>Epinephryl borate</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/NCT02255591
org study id: AUH-TFB-SR
secondary id: 2013-005346-10
nct id: NCT02255591
lead sponsor: 
collaborator: 
has dmc: Yes
The main objective of the trial is to complete a double-blinded randomized controlled trial
      of a lumbar plexus block with the Shamrock technique versus the Lumbar Ultrasound Trident
      technique by estimating the time of performance of lumbar plexus blocks in healthy
      volunteers.

      Secondary objectives include a) estimates of number and depth of needle injections, distance
      of injection site from the midline, minimal electric nerve stimulation to trigger muscular
      response and the type of response, and volunteer discomfort during block injection, b)
      measurements of plasma lidocaine and mean arterial blood pressure, c) examinations of sensory
      block of the dermatomes T8-S3 and motor block of the femoral nerve, the obturator nerve, the
      hip abductor muscles, and the hamstring muscles, d) success rate of lumbar plexus block, e)
      perineural and epidural distribution of local anesthetics added contrast visualized on
      magnetic resonance imaging (MRI) scanning, and f) cost-effectiveness for the Shamrock
      technique versus the Lumbar Ultrasound Trident Technique for lumbar plexus block in healthy
      volunteers.

      The hypothesis is that the Shamrock technique is faster to perform than the Lumbar Ultrasound
      technique, and that the success rate of the Shamrock technique is equal to or higher than the
      Lumbar Ultrasound Trident technique.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Block performance time
time frame: Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
description: Time for performance of lumbar plexus block in seconds from placement of the ultrasound transducer on the skin until the block needle is pulled out after injection of local anesthetics.
measure: Number of needle feeds
time frame: Estimated 0 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
description: Needle feeds are defined as retraction of needle followed by new feed of the needle disregarding the number of skin punctures.
measure: Discomfort during block placement
time frame: Estimated 1 minute after block placement. Presented 10 months after the last visit of the last volunteer.
description: Discomfort is measured with Numeric Rating Scale (NRS).
measure: Plasma Lidocaine
time frame: Blood samples are withdrawn 0, 5, 10, 20, 40, 60, and 90 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
measure: Mear arterial pressure
time frame: Measured 5 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
measure: Cost-effectiveness
time frame: Calculated two weeks after the last visit of the last volunteer. Presented 10 months after the last visit of the last volunteer.
description: Cost-effectiveness estimated as extra expense per successful lumbar plexus block and calculated as incremental cost-effectiveness ratio (ICER).
measure: Sensor block
time frame: Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
description: Sensor block (cold, warm, touch, and pain) of the dermatomes T8-S3 and of the femoral nerve and the lateral femoral cutaneous nerve.
measure: Motor block
time frame: Tested 40 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
description: Motor block of the femoral nerve (knee extension), the obturator nerve (hip adduction), the superior gluteal nerve (hip abduction), and the sciatic nerve (knee flexion) estimated as active resistance against movement of the relevant joint and with sphygmomanometer of the relevant joint as maximal voluntary isometric contraction with dynamometer (mmHg).
measure: Block success rate
time frame: Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
description: Success rate defined as motor block of the femoral nerve (knee extension) and the obturator nerve (hip adduction) and reduced sensory of the lateral femoral cutaneous nerve (middle of the lateral side of the thigh).
measure: Block success rate
time frame: Tested 30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
description: Defined as above after lumbar plexus block with the Shamrock technique for motor response on electrical nerve stimulation above respectively below 0,5 milliampere (mA).
measure: Epidural spread of local anesthetics with contrast
time frame: Estimated 10-30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
description: Estimated with T1- and T2-weighted and with diffusion weighted imaging (DWI) MR scanning.
measure: Perineural spread of local anesthetics with added contrast
time frame: Estimated 10-30 minutes after block placement. Presented 10 months after the last visit of the last volunteer.
description: Estimated with T1- and T2-weighted and with DWI MR scanning.
measure: Depth of block needle
time frame: Estimated during block
description: The depth in cm from the injection site in the skin to the needle tips position during injection. of local anesthetics
measure: Injection site
time frame: Estimated immediately after block placement
description: The distance in cm from the injection site of the block needle to the midline of the volunteer.
measure: Minimal electrical nerve stimulation
time frame: Estimated immediately before injection of local anesthetics during block placement
description: The estimated minimal electrical nerve stimulation in mA to trigger a muscular response.
measure: Type of response on electrical nerve stimulation
time frame: Assessed immediately before injection of local anesthetics during block placement
description: The type of response triggered by electrical nerve stimulation.
arm group label: Shamrock
arm group type: Experimental
description: Use of the Shamrock technique to place a lumbar plexus block with injection of 20 mL 2% Lidocaine-adrenaline added gadolinium.
arm group label: Lumbar Ultrasound Trident
arm group type: Active Comparator
description: Use of the Lumbar Ultrasound Trident technique to place a lumbar plexus block with injection of 20 mL 2% lidocaine-adrenaline added gadolinium.
intervention type: Drug
intervention name: Lidocaine-adrenaline added gadolinium.
arm group label: Lumbar Ultrasound Trident
arm group label: Shamrock
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas F Bendtsen, MD,PhD,Prof.
role: Principal Investigator
affiliation: Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Noerrebrogade 44, DK-8000 Aarhus C, Denmark
facility: 
country: Denmark
citation: de Visme V, Picart F, Le Jouan R, Legrand A, Savry C, Morin V. Combined lumbar and sacral plexus block compared with plain bupivacaine spinal anesthesia for hip fractures in the elderly. Reg Anesth Pain Med. 2000 Mar-Apr;25(2):158-62. doi: 10.1053/rapm.2000.0250158.
PMID: 10746528
citation: Kirchmair L, Entner T, Kapral S, Mitterschiffthaler G. Ultrasound guidance for the psoas compartment block: an imaging study. Anesth Analg. 2002 Mar;94(3):706-10; table of contents. doi: 10.1097/00000539-200203000-00042.
PMID: 11867402
citation: Kirchmair L, Entner T, Wissel J, Moriggl B, Kapral S, Mitterschiffthaler G. A study of the paravertebral anatomy for ultrasound-guided posterior lumbar plexus block. Anesth Analg. 2001 Aug;93(2):477-81, 4th contents page. doi: 10.1097/00000539-200108000-00047.
PMID: 11473883
citation: Morimoto M, Kim JT, Popovic J, Jain S, Bekker A. Ultrasound-guided lumbar plexus block for open reduction and internal fixation of hip fracture. Pain Pract. 2006 Jun;6(2):124-6. doi: 10.1111/j.1533-2500.2006.00074.x.
PMID: 17309721
citation: Doi K, Sakura S, Hara K. A modified posterior approach to lumbar plexus block using a transverse ultrasound image and an approach from the lateral border of the transducer. Anaesth Intensive Care. 2010 Jan;38(1):213-4. No abstract available.
PMID: 20191806
citation: Madison SJ, Ilfeld BM, Loland VJ, Mariano ER. Posterior lumbar plexus perineural catheter insertion by ultrasound guidance alone. Acta Anaesthesiol Scand. 2011 Sep;55(8):1031-2. doi: 10.1111/j.1399-6576.2011.02489.x. Epub 2011 Jul 20. No abstract available.
PMID: 21770905
citation: Karmakar MK, Ho AM, Li X, Kwok WH, Tsang K, Ngan Kee WD. Ultrasound-guided lumbar plexus block through the acoustic window of the lumbar ultrasound trident. Br J Anaesth. 2008 Apr;100(4):533-7. doi: 10.1093/bja/aen026.
PMID: 18344573
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Hip Fractures
mesh term: Lidocaine
mesh term: Epinephrine
mesh term: Racepinephrine
mesh term: Epinephryl borate