<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/NCT02993939</url>
  </required_header>
  <id_info>
    <org_study_id>853/16</org_study_id>
    <nct_id>NCT02993939</nct_id>
  </id_info>
  <brief_title>Interscalene Block Versus Infraclavicular Block Plus Suprascapular Nerve Block</brief_title>
  <acronym>ISBvsICB-SSB</acronym>
  <official_title>A Randomized Comparison Between Interscalene Brachial Plexus Block and Combined Infraclavicular Brachial Plexus Block-Suprascapular Nerve Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chile</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite their reliability and efficacy for shoulder surgery analgesia, above clavicle&#xD;
      brachial plexus blocks are related with phrenic nerve palsy and diaphragm paralysis that may&#xD;
      not be tolerated in patients with chronic pulmonary disease.&#xD;
&#xD;
      This RCT will compare the classic Interscalene block with combined infraclavicular block plus&#xD;
      suprascapular nerve block in patients going for arthroscopic shoulder surgery.&#xD;
&#xD;
      Main outcome is static pain in the recovery room measured with NRS. Secondary outcomes are&#xD;
      pain at 12 and 24 hrs and incidence of diaphragmatic paralysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PATIENT RECRUITMENT&#xD;
&#xD;
      With the approval of the Ethics Committee of Hospital Clinico Universidad de Chile, 40&#xD;
      patients undergoing arthroscopic shoulder surgery will be recruited. Enrollment will be&#xD;
      carried out by an investigator not involved in patient care. Patients' confidentiality will&#xD;
      be protected.&#xD;
&#xD;
      STUDY PROTOCOL: GENERAL&#xD;
&#xD;
      All blocks will be performed by one of the coauthors and conducted preoperatively in an&#xD;
      induction room. Sedation (2 mg midazolam and 50 μg fentanyl) will be provided for patient&#xD;
      comfort.&#xD;
&#xD;
      STUDY PROTOCOL: PERFORMANCE OF THE BLOCK&#xD;
&#xD;
      Both study groups will receive an ultrasound-guided superficial cervical plexus block.&#xD;
&#xD;
      In the ICB-SSB group, suprascapular nerve blocks will be carried out using a previously&#xD;
      described technique. For infraclavicular brachial plexus blocks, 20 mL of levobupivacaine&#xD;
      0.25% with epinephrine 5 µg/mL will be injected dorsal to the axillary artery, medial to the&#xD;
      coracoid process.&#xD;
&#xD;
      In the ISB group, block will carried out using a previously described technique: 20 mL of&#xD;
      levobupivacaine 0.25% with epinephrine 5 µg/mL will be deposited under the prevertebral&#xD;
      fascial between the C5 and C6 roots.&#xD;
&#xD;
      STUDY PROTOCOL: GENERAL ANESTHESIA&#xD;
&#xD;
      All patients will undergo standardized general anesthesia&#xD;
&#xD;
      STUDY PROTOCOL: POSTOPERATIVE ANALGESIA&#xD;
&#xD;
      In the Recovery Room, all patients will receive acetaminophen (usual dose…) and ketoprofen&#xD;
      (usual dose…) as well as patient controlled analgesia (morphine bolus = 1 mg; lockout&#xD;
      interval = 8 minutes). On the surgical ward, all subjects will continue to receive&#xD;
      acetaminophen (usual dise…), celecoxib (usual dose…) as well and patient controlled analgesia&#xD;
      (morphine bolus = 1 mg IV; lockout interval = 8 minutes).&#xD;
&#xD;
      STUDY PROTOCOL: OUTCOME MEASUREMENTS&#xD;
&#xD;
      The primary outcome will be the pain score in the PACU at 30 30 minutes using a sensorimotor&#xD;
      composite scale:&#xD;
&#xD;
      Performance time, sensorimotorSensory function, Onset time&#xD;
&#xD;
      The blinded investigator will also assess the presence of hemidiaphragmatic block at 30&#xD;
      minutes. A 2-6 MHz curvilinear US probe (Sonosite M-Turbo, SonoSite Inc, Bothell, WA, USA)&#xD;
      and the M-mode will be employed in all subjects; the liver and spleen will serve as acoustic&#xD;
      windows on the right and left side, respectively. Patients will be scanned along the anterior&#xD;
      axillary line and the US probe, angled cranially&#xD;
&#xD;
      POTENTIAL BENEFITS OF THE STUDY This study will allow us to determine if ICB-SSB constitutes&#xD;
      a viable alternative to ISB.&#xD;
&#xD;
      POTENTIAL SIDE EFFECTS OF THE STUDY Participation in this protocol will not put patients at&#xD;
      higher risk for complications since ISB and ICB-SSB are commonly used to provide analgesia&#xD;
      for shoulder surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">April 28, 2017</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Static Pain using numeric scale 0-10</measure>
    <time_frame>30 minutes after arrival to PACU</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Static Pain using numeric scale 0-10</measure>
    <time_frame>12 hrs after arrival to PACU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diaphragm paralysis incidence</measure>
    <time_frame>30 minutes after block</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static Pain using numeric scale 0-10</measure>
    <time_frame>24 hrs</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Shoulder Injury</condition>
  <arm_group>
    <arm_group_label>Interscalene block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasound guided Brachial plexus block injecting 20 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml, in the Interscalene groove.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diaphragm-sparing block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound guided combinated infraclavicular-Suprascapular block of the braquial plexus, injecting 20 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml dorsal to the axillary artery in the infraclavicular fossa plus an Ultrasound guided injection of 10 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml in the suprascapular fossa.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Interscalene block</intervention_name>
    <description>Ultrasound guided single shot block above the clavicle</description>
    <arm_group_label>Interscalene block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Infraclavicular-suprascapular block</intervention_name>
    <description>Combined block of nerves far away from phrenic nerve</description>
    <arm_group_label>Diaphragm-sparing block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 and 75 years&#xD;
&#xD;
          -  American Society of Anesthesiologists classification 1-3&#xD;
&#xD;
          -  body mass index between 20 and 30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  adults who are unable to give their own consent&#xD;
&#xD;
          -  pre-existing neuropathy (assessed by history and physical examination)&#xD;
&#xD;
          -  coagulopathy (assessed by history and physical examination and, if deemed clinically&#xD;
             necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4&#xD;
             or prothrombin time ≥ 50)&#xD;
&#xD;
          -  obstructive or restrictive pulmonary disease (assessed by history and physical&#xD;
             examination)&#xD;
&#xD;
          -  renal failure (assessed by history and physical examination and, if deemed clinically&#xD;
             necessary, by blood work up i.e. creatinine ≥ 100)&#xD;
&#xD;
          -  hepatic failure (assessed by history and physical examination and, if deemed&#xD;
             clinically necessary, by blood work up i.e. transaminases ≥ 100)&#xD;
&#xD;
          -  allergy to local anesthetics (LAs)&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  prior surgery in the neck, infraclavicular region or suprascapular fossa&#xD;
&#xD;
          -  chronic pain syndromes requiring opioid intake at home&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Clinico Universidad de Chile</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitan</state>
        <zip>8380456</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <results_reference>
    <citation>Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb. Erratum In: Reg Anesth Pain Med. 2010 Jul-Aug;35(4):407.</citation>
    <PMID>19282714</PMID>
  </results_reference>
  <results_reference>
    <citation>Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.</citation>
    <PMID>2006740</PMID>
  </results_reference>
  <results_reference>
    <citation>Martinez J, Sala-Blanch X, Ramos I, Gomar C. Combined infraclavicular plexus block with suprascapular nerve block for humeral head surgery in a patient with respiratory failure: an alternative approach. Anesthesiology. 2003 Mar;98(3):784-5. doi: 10.1097/00000542-200303000-00031. No abstract available.</citation>
    <PMID>12606927</PMID>
  </results_reference>
  <results_reference>
    <citation>Tran DQ, Dugani S, Finlayson RJ. A randomized comparison between ultrasound-guided and landmark-based superficial cervical plexus block. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):539-43. doi: 10.1097/AAP.0b013e3181faa11c.</citation>
    <PMID>20975470</PMID>
  </results_reference>
  <results_reference>
    <citation>Chan CW, Peng PW. Suprascapular nerve block: a narrative review. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):358-73. doi: 10.1097/AAP.0b013e3182204ec0.</citation>
    <PMID>21654552</PMID>
  </results_reference>
  <results_reference>
    <citation>Tran DQ, Bertini P, Zaouter C, Munoz L, Finlayson RJ. A prospective, randomized comparison between single- and double-injection ultrasound-guided infraclavicular brachial plexus block. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):16-21. doi: 10.1097/AAP.0b013e3181c7717c.</citation>
    <PMID>20048654</PMID>
  </results_reference>
  <results_reference>
    <citation>Spence BC, Beach ML, Gallagher JD, Sites BD. Ultrasound-guided interscalene blocks: understanding where to inject the local anaesthetic. Anaesthesia. 2011 Jun;66(6):509-14. doi: 10.1111/j.1365-2044.2011.06712.x.</citation>
    <PMID>21568985</PMID>
  </results_reference>
  <results_reference>
    <citation>Flohr-Madsen S, Ytrebo LM, Valen K, Wilsgaard T, Klaastad O. A randomised placebo-controlled trial examining the effect on hand supination after the addition of a suprascapular nerve block to infraclavicular brachial plexus blockade. Anaesthesia. 2016 Aug;71(8):938-47. doi: 10.1111/anae.13504.</citation>
    <PMID>27396247</PMID>
  </results_reference>
  <results_reference>
    <citation>Lloyd T, Tang YM, Benson MD, King S. Diaphragmatic paralysis: the use of M mode ultrasound for diagnosis in adults. Spinal Cord. 2006 Aug;44(8):505-8. doi: 10.1038/sj.sc.3101889. Epub 2005 Dec 6.</citation>
    <PMID>16331304</PMID>
  </results_reference>
  <results_reference>
    <citation>Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Nerve Block for Analgesia in Arthroscopic Shoulder Surgery: An Equivalence Study. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):564-71. doi: 10.1097/AAP.0000000000000436.</citation>
    <PMID>27380105</PMID>
  </results_reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>May 2, 2017</last_update_submitted>
  <last_update_submitted_qc>May 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Chile</investigator_affiliation>
    <investigator_full_name>Julian Aliste</investigator_full_name>
    <investigator_title>MD Clinical Instructor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Injuries</mesh_term>
  </condition_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/NCT02993939
org study id: 853/16
nct id: NCT02993939
lead sponsor: 
has dmc: Yes
Despite their reliability and efficacy for shoulder surgery analgesia, above clavicle
      brachial plexus blocks are related with phrenic nerve palsy and diaphragm paralysis that may
      not be tolerated in patients with chronic pulmonary disease.

      This RCT will compare the classic Interscalene block with combined infraclavicular block plus
      suprascapular nerve block in patients going for arthroscopic shoulder surgery.

      Main outcome is static pain in the recovery room measured with NRS. Secondary outcomes are
      pain at 12 and 24 hrs and incidence of diaphragmatic paralysis.
PATIENT RECRUITMENT

      With the approval of the Ethics Committee of Hospital Clinico Universidad de Chile, 40
      patients undergoing arthroscopic shoulder surgery will be recruited. Enrollment will be
      carried out by an investigator not involved in patient care. Patients' confidentiality will
      be protected.

      STUDY PROTOCOL: GENERAL

      All blocks will be performed by one of the coauthors and conducted preoperatively in an
      induction room. Sedation (2 mg midazolam and 50 μg fentanyl) will be provided for patient
      comfort.

      STUDY PROTOCOL: PERFORMANCE OF THE BLOCK

      Both study groups will receive an ultrasound-guided superficial cervical plexus block.

      In the ICB-SSB group, suprascapular nerve blocks will be carried out using a previously
      described technique. For infraclavicular brachial plexus blocks, 20 mL of levobupivacaine
      0.25% with epinephrine 5 µg/mL will be injected dorsal to the axillary artery, medial to the
      coracoid process.

      In the ISB group, block will carried out using a previously described technique: 20 mL of
      levobupivacaine 0.25% with epinephrine 5 µg/mL will be deposited under the prevertebral
      fascial between the C5 and C6 roots.

      STUDY PROTOCOL: GENERAL ANESTHESIA

      All patients will undergo standardized general anesthesia

      STUDY PROTOCOL: POSTOPERATIVE ANALGESIA

      In the Recovery Room, all patients will receive acetaminophen (usual dose…) and ketoprofen
      (usual dose…) as well as patient controlled analgesia (morphine bolus = 1 mg; lockout
      interval = 8 minutes). On the surgical ward, all subjects will continue to receive
      acetaminophen (usual dise…), celecoxib (usual dose…) as well and patient controlled analgesia
      (morphine bolus = 1 mg IV; lockout interval = 8 minutes).

      STUDY PROTOCOL: OUTCOME MEASUREMENTS

      The primary outcome will be the pain score in the PACU at 30 30 minutes using a sensorimotor
      composite scale:

      Performance time, sensorimotorSensory function, Onset time

      The blinded investigator will also assess the presence of hemidiaphragmatic block at 30
      minutes. A 2-6 MHz curvilinear US probe (Sonosite M-Turbo, SonoSite Inc, Bothell, WA, USA)
      and the M-mode will be employed in all subjects; the liver and spleen will serve as acoustic
      windows on the right and left side, respectively. Patients will be scanned along the anterior
      axillary line and the US probe, angled cranially

      POTENTIAL BENEFITS OF THE STUDY This study will allow us to determine if ICB-SSB constitutes
      a viable alternative to ISB.

      POTENTIAL SIDE EFFECTS OF THE STUDY Participation in this protocol will not put patients at
      higher risk for complications since ISB and ICB-SSB are commonly used to provide analgesia
      for shoulder surgery
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Static Pain using numeric scale 0-10
time frame: 30 minutes after arrival to PACU
measure: Static Pain using numeric scale 0-10
time frame: 12 hrs after arrival to PACU
measure: Diaphragm paralysis incidence
time frame: 30 minutes after block
measure: Static Pain using numeric scale 0-10
time frame: 24 hrs
arm group label: Interscalene block
arm group type: Active Comparator
description: Ultrasound guided Brachial plexus block injecting 20 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml, in the Interscalene groove.
arm group label: Diaphragm-sparing block
arm group type: Experimental
description: Ultrasound guided combinated infraclavicular-Suprascapular block of the braquial plexus, injecting 20 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml dorsal to the axillary artery in the infraclavicular fossa plus an Ultrasound guided injection of 10 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml in the suprascapular fossa.
intervention type: Procedure
intervention name: Interscalene block
description: Ultrasound guided single shot block above the clavicle
arm group label: Interscalene block
intervention type: Procedure
intervention name: Infraclavicular-suprascapular block
description: Combined block of nerves far away from phrenic nerve
arm group label: Diaphragm-sparing block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Chile
citation: Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb. Erratum In: Reg Anesth Pain Med. 2010 Jul-Aug;35(4):407.
PMID: 19282714
citation: Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
PMID: 2006740
citation: Martinez J, Sala-Blanch X, Ramos I, Gomar C. Combined infraclavicular plexus block with suprascapular nerve block for humeral head surgery in a patient with respiratory failure: an alternative approach. Anesthesiology. 2003 Mar;98(3):784-5. doi: 10.1097/00000542-200303000-00031. No abstract available.
PMID: 12606927
citation: Tran DQ, Dugani S, Finlayson RJ. A randomized comparison between ultrasound-guided and landmark-based superficial cervical plexus block. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):539-43. doi: 10.1097/AAP.0b013e3181faa11c.
PMID: 20975470
citation: Chan CW, Peng PW. Suprascapular nerve block: a narrative review. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):358-73. doi: 10.1097/AAP.0b013e3182204ec0.
PMID: 21654552
citation: Tran DQ, Bertini P, Zaouter C, Munoz L, Finlayson RJ. A prospective, randomized comparison between single- and double-injection ultrasound-guided infraclavicular brachial plexus block. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):16-21. doi: 10.1097/AAP.0b013e3181c7717c.
PMID: 20048654
citation: Spence BC, Beach ML, Gallagher JD, Sites BD. Ultrasound-guided interscalene blocks: understanding where to inject the local anaesthetic. Anaesthesia. 2011 Jun;66(6):509-14. doi: 10.1111/j.1365-2044.2011.06712.x.
PMID: 21568985
citation: Flohr-Madsen S, Ytrebo LM, Valen K, Wilsgaard T, Klaastad O. A randomised placebo-controlled trial examining the effect on hand supination after the addition of a suprascapular nerve block to infraclavicular brachial plexus blockade. Anaesthesia. 2016 Aug;71(8):938-47. doi: 10.1111/anae.13504.
PMID: 27396247
citation: Lloyd T, Tang YM, Benson MD, King S. Diaphragmatic paralysis: the use of M mode ultrasound for diagnosis in adults. Spinal Cord. 2006 Aug;44(8):505-8. doi: 10.1038/sj.sc.3101889. Epub 2005 Dec 6.
PMID: 16331304
citation: Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Nerve Block for Analgesia in Arthroscopic Shoulder Surgery: An Equivalence Study. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):564-71. doi: 10.1097/AAP.0000000000000436.
PMID: 27380105
responsible party type: Principal Investigator
investigator affiliation: University of Chile
investigator full name: Julian Aliste
investigator title: MD Clinical Instructor
mesh term: Shoulder Injuries
sharing ipd: No