<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/NCT03797924</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201802525</org_study_id>
    <secondary_id>OCR19802</secondary_id>
    <nct_id>NCT03797924</nct_id>
  </id_info>
  <brief_title>Intercostobrachial Nerve Block (ICBN) for Tourniquet Pain: Is it Necessary?</brief_title>
  <acronym>ICBN</acronym>
  <official_title>Intercostobrachial Nerve Block (ICBN) for Tourniquet Pain: Is it Necessary?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the investigators would like to show that when patients undergo upper limb&#xD;
      surgery under supraclavicular brachial plexus block, additional blocking of the&#xD;
      Intercostobrachial Nerve Block (ICBN) does not affect the incidence or course of tourniquet&#xD;
      pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ICBN is a cutaneous sensory nerve that supplies the medial aspect of the upper arm.&#xD;
      Traditionally this nerve is blocked to alleviate tourniquet pain. The etiology of tourniquet&#xD;
      pain is complex and the study team hypothesize that blocking the ICBN has no impact on&#xD;
      tourniquet pain. Patients will receive a supraclavicular block and be divided into two&#xD;
      groups; ICBN with local anesthetic or ICBN with saline. All patients in this study will&#xD;
      receive a supraclavicular block as their primary anesthetic and then be divided into two&#xD;
      groups; those who receive ICBN and those who do not. Amount of intraoperative analgesics,&#xD;
      conversion to deep sedation or general anesthesia, and onset of time to tourniquet pain will&#xD;
      be the primary measures of this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2019</start_date>
  <completion_date type="Actual">December 13, 2021</completion_date>
  <primary_completion_date type="Actual">December 20, 2020</primary_completion_date>
  <phase>Early Phase 1</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>
    <intervention_model_description>Patients will be randomized to receive ICBN with ropivacaine or no ICBN or ropivacaine.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>In order to blind anesthesia providers in the room and nurses in Post-op Anesthesia Care Unit (PACU), the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change between the 2 groups assessed by the incidence of tourniquet pain reported by the patient on a Descriptor Differential Scale of Pain Intensity (DDSI)</measure>
    <time_frame>From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)</time_frame>
    <description>Tourniquet pain defined by the presence of dull or aching pain underneath the tourniquet</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change between the 2 groups depth of anesthesia during surgery to alleviate tourniquet pain as assessed by the American Society of Anesthesiologist (ASA) Continuum of Depth of Sedation definition of general anesthesia and levels of sedation/analgesia.</measure>
    <time_frame>From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)</time_frame>
    <description>Determine required depth of anesthesia during surgery to alleviate tourniquet pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change between the 2 groups assessed by intraoperative opioid consumption</measure>
    <time_frame>From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)</time_frame>
    <description>Determine amount of intraoperative opioid consumption due to tourniquet pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change between the 2 groups assessed by time to onset of tourniquet pain</measure>
    <time_frame>From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)</time_frame>
    <description>Determine the time to onset of tourniquet pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change between the 2 groups in reported severity of tourniquet pain</measure>
    <time_frame>From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)</time_frame>
    <description>Determine if ICBN has an affect on the severity of tourniquet pain as assessed by Descriptor Differential Scale of Pain Intensity (DDSI) There are 10 points along which patients can rate their pain intensity to the right and left of each descriptor, so the pain is rated on a 21 point scale for each descriptor. Pain intensity is defined as a mean of the ratings and can range from 0 to 20.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Nerve Block</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>ICBN with ropivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive ICBN with ropivacaine. In order to blind anesthesia providers in the room and nurses in PACU, the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No ICBN block</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will have the site prepped, but no ICBN block given. In order to blind anesthesia providers in the room and nurses in PACU, the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Receive ICBN with ropivacaine</intervention_name>
    <description>ICBN block will be performed using US guidance depositing 10 ml of 0.5% ropivacaine in the plane between pectoralis minor and serratus anterior over the 2nd and 3rd intercostal space.</description>
    <arm_group_label>ICBN with ropivacaine</arm_group_label>
    <other_name>Naropin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No ICBN block</intervention_name>
    <description>The site of injection will be prepped with tinted chlorhexidine</description>
    <arm_group_label>No ICBN block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) 1-3&#xD;
&#xD;
          -  Distal upper extremity surgery with anticipated use of tourniquet&#xD;
&#xD;
          -  Outpatient surgery&#xD;
&#xD;
          -  Patients who desire regional anesthesia as primary anesthetic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA 4 or greater&#xD;
&#xD;
          -  Allergies to local anesthetic&#xD;
&#xD;
          -  Refusal of regional anesthesia&#xD;
&#xD;
          -  History of chronic pain syndromes&#xD;
&#xD;
          -  Patients who do not desire regional anesthesia as primary anesthetic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Linda Le-Wendling, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Satsumae T, Yamaguchi H, Inomata S, Tanaka M. Magnesium sulfate attenuates tourniquet pain in healthy volunteers. J Anesth. 2013 Apr;27(2):231-5. doi: 10.1007/s00540-012-1493-4. Epub 2012 Oct 7.</citation>
    <PMID>23053464</PMID>
  </results_reference>
  <results_reference>
    <citation>Hagenouw RR, Bridenbaugh PO, van Egmond J, Stuebing R. Tourniquet pain: a volunteer study. Anesth Analg. 1986 Nov;65(11):1175-80.</citation>
    <PMID>3767015</PMID>
  </results_reference>
  <results_reference>
    <citation>Valli H, Rosenberg PH, Kytta J, Nurminen M. Arterial hypertension associated with the use of a tourniquet with either general or regional anaesthesia. Acta Anaesthesiol Scand. 1987 May;31(4):279-83. doi: 10.1111/j.1399-6576.1987.tb02566.x.</citation>
    <PMID>3591250</PMID>
  </results_reference>
  <results_reference>
    <citation>Crews JC, Cahall M, Behbehani MM. The neurophysiologic mechanisms of tourniquet pain. The activity of neurons in the rostroventral medulla in the rat. Anesthesiology. 1994 Sep;81(3):730-6. doi: 10.1097/00000542-199409000-00027.</citation>
    <PMID>8092519</PMID>
  </results_reference>
  <results_reference>
    <citation>MacIver MB, Tanelian DL. Activation of C fibers by metabolic perturbations associated with tourniquet ischemia. Anesthesiology. 1992 Apr;76(4):617-23. doi: 10.1097/00000542-199204000-00020.</citation>
    <PMID>1550287</PMID>
  </results_reference>
  <results_reference>
    <citation>Tschaikowsky K, Hemmerling T. Comparison of the effect of EMLA and semicircular subcutaneous anaesthesia in the prevention of tourniquet pain during plexus block anaesthesia of the arm. Anaesthesia. 1998 Apr;53(4):390-3. doi: 10.1046/j.1365-2044.1998.00301.x.</citation>
    <PMID>9613307</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>May 23, 2022</last_update_submitted>
  <last_update_submitted_qc>May 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intercostobrachial Nerve Block</keyword>
  <keyword>Tourniquet Pain</keyword>
  <keyword>Upper Limb Surgeries</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03797924
org study id: IRB201802525
secondary id: OCR19802
nct id: NCT03797924
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
In this study the investigators would like to show that when patients undergo upper limb
      surgery under supraclavicular brachial plexus block, additional blocking of the
      Intercostobrachial Nerve Block (ICBN) does not affect the incidence or course of tourniquet
      pain.
The ICBN is a cutaneous sensory nerve that supplies the medial aspect of the upper arm.
      Traditionally this nerve is blocked to alleviate tourniquet pain. The etiology of tourniquet
      pain is complex and the study team hypothesize that blocking the ICBN has no impact on
      tourniquet pain. Patients will receive a supraclavicular block and be divided into two
      groups; ICBN with local anesthetic or ICBN with saline. All patients in this study will
      receive a supraclavicular block as their primary anesthetic and then be divided into two
      groups; those who receive ICBN and those who do not. Amount of intraoperative analgesics,
      conversion to deep sedation or general anesthesia, and onset of time to tourniquet pain will
      be the primary measures of this study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized to receive ICBN with ropivacaine or no ICBN or ropivacaine.
primary purpose: Basic Science
masking: Double (Participant, Care Provider)
masking description: In order to blind anesthesia providers in the room and nurses in Post-op Anesthesia Care Unit (PACU), the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients.
measure: Change between the 2 groups assessed by the incidence of tourniquet pain reported by the patient on a Descriptor Differential Scale of Pain Intensity (DDSI)
time frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
description: Tourniquet pain defined by the presence of dull or aching pain underneath the tourniquet
measure: Change between the 2 groups depth of anesthesia during surgery to alleviate tourniquet pain as assessed by the American Society of Anesthesiologist (ASA) Continuum of Depth of Sedation definition of general anesthesia and levels of sedation/analgesia.
time frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
description: Determine required depth of anesthesia during surgery to alleviate tourniquet pain
measure: Change between the 2 groups assessed by intraoperative opioid consumption
time frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
description: Determine amount of intraoperative opioid consumption due to tourniquet pain
measure: Change between the 2 groups assessed by time to onset of tourniquet pain
time frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
description: Determine the time to onset of tourniquet pain
measure: Change between the 2 groups in reported severity of tourniquet pain
time frame: From intraoperative pre tourniquet insufflation to intraoperative release of tourniquet (up to 2 hours)
description: Determine if ICBN has an affect on the severity of tourniquet pain as assessed by Descriptor Differential Scale of Pain Intensity (DDSI) There are 10 points along which patients can rate their pain intensity to the right and left of each descriptor, so the pain is rated on a 21 point scale for each descriptor. Pain intensity is defined as a mean of the ratings and can range from 0 to 20.
arm group label: ICBN with ropivacaine
arm group type: Active Comparator
description: Participants will receive ICBN with ropivacaine. In order to blind anesthesia providers in the room and nurses in PACU, the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients.
arm group label: No ICBN block
arm group type: Placebo Comparator
description: Participants will have the site prepped, but no ICBN block given. In order to blind anesthesia providers in the room and nurses in PACU, the site of injection for ICBN will be prepped with tinted chlorhexidine in all patients.
intervention type: Drug
intervention name: Receive ICBN with ropivacaine
description: ICBN block will be performed using US guidance depositing 10 ml of 0.5% ropivacaine in the plane between pectoralis minor and serratus anterior over the 2nd and 3rd intercostal space.
arm group label: ICBN with ropivacaine
other name: Naropin
intervention type: Behavioral
intervention name: No ICBN block
description: The site of injection will be prepped with tinted chlorhexidine
arm group label: No ICBN block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Linda Le-Wendling, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
citation: Satsumae T, Yamaguchi H, Inomata S, Tanaka M. Magnesium sulfate attenuates tourniquet pain in healthy volunteers. J Anesth. 2013 Apr;27(2):231-5. doi: 10.1007/s00540-012-1493-4. Epub 2012 Oct 7.
PMID: 23053464
citation: Hagenouw RR, Bridenbaugh PO, van Egmond J, Stuebing R. Tourniquet pain: a volunteer study. Anesth Analg. 1986 Nov;65(11):1175-80.
PMID: 3767015
citation: Valli H, Rosenberg PH, Kytta J, Nurminen M. Arterial hypertension associated with the use of a tourniquet with either general or regional anaesthesia. Acta Anaesthesiol Scand. 1987 May;31(4):279-83. doi: 10.1111/j.1399-6576.1987.tb02566.x.
PMID: 3591250
citation: Crews JC, Cahall M, Behbehani MM. The neurophysiologic mechanisms of tourniquet pain. The activity of neurons in the rostroventral medulla in the rat. Anesthesiology. 1994 Sep;81(3):730-6. doi: 10.1097/00000542-199409000-00027.
PMID: 8092519
citation: MacIver MB, Tanelian DL. Activation of C fibers by metabolic perturbations associated with tourniquet ischemia. Anesthesiology. 1992 Apr;76(4):617-23. doi: 10.1097/00000542-199204000-00020.
PMID: 1550287
citation: Tschaikowsky K, Hemmerling T. Comparison of the effect of EMLA and semicircular subcutaneous anaesthesia in the prevention of tourniquet pain during plexus block anaesthesia of the arm. Anaesthesia. 1998 Apr;53(4):390-3. doi: 10.1046/j.1365-2044.1998.00301.x.
PMID: 9613307
responsible party type: Sponsor
mesh term: Ropivacaine
sharing ipd: No