<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/NCT03279679</url>
  </required_header>
  <id_info>
    <org_study_id>TJ-IRB20170702</org_study_id>
    <nct_id>NCT03279679</nct_id>
  </id_info>
  <brief_title>Comparison Between Costoclavicular and Paracoracoid Ultrasound-guided Infraclavicular Block for Forearm Surgery</brief_title>
  <official_title>A Randomized Comparison of Minimum Effective Volume With 0.5% Ropivacaine Between Costoclavicular and Paracoracoid Ultrasound-guided Infraclavicular Block for Forearm Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huazhong University of Science and Technology</source>
  <oversight_info>
    <has_dmc>No</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>
      The costoclavicular space block technique is a new developed approach of ultrasound-guided&#xD;
      infraclavicular brachial plexus block(USG-ICB) in last two years and has not been studied&#xD;
      much yet. The paracoracoid approach serves as a standard and traditional method for USG-ICB&#xD;
      in clinical practice, easy to learn and perform. The investigators set this parallel&#xD;
      controlled dose-finding trial to work out the MEV with 0.5% ropivacaine of both two&#xD;
      approaches above for forearm surgery and compare the performance time between them, providing&#xD;
      reasonable evidence for clinical choice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The costoclavicular space block technique is a new developed approach of ultrasound-guided&#xD;
      infraclavicular brachial plexus block(USG-ICB) in last two years and has not been studied&#xD;
      much yet. USG-ICB represents an attractive option for upper-limb surgery at or below the&#xD;
      elbow joint with similar success rate and fewer adverse effects compared with&#xD;
      ultrasound-guided supraclavicular block. The paracoracoid approach serves as a standard and&#xD;
      traditional method for USG-ICB in clinical practice, easy to learn and perform. However, the&#xD;
      minimum effective volume(MEV)of this approach has been studied by different investigators&#xD;
      with different regional anesthetics or its mixture, and specially, the 95% MEV result of this&#xD;
      approach is more than 30ml in all related researches which is still a large volume. According&#xD;
      to the investigators' experience in using the costoclavicular space technique for forearm&#xD;
      surgery, it usually can get a comparable sensation and motor block effect by no more than&#xD;
      25ml. Recently, there was a clinical randomized control study which compared the&#xD;
      costoclavicular and paracoracoid USG-ICB for upper limb surgery using a 35ml-mixture of 1%&#xD;
      lidocaine-0.25% bupivacaine with epinephrine 5 ug/ml and came to the conclusions: two groups&#xD;
      resulted in similar onset times and no intergroup difference were found in terms of&#xD;
      performance time and success rate. However, 35ml is a much larger regional anesthetic volume&#xD;
      than what we used in routine brachial plexus block. So, we set this parallel controlled&#xD;
      dose-finding trial to work out the MEV with 0.5% ropivacaine of both approaches above for&#xD;
      forearm surgery and compare the performance time between them, providing reasonable evidence&#xD;
      for clinical choice. Patients enrolled in this study will be assigned to costoclavicular&#xD;
      group and paracoracoid group and in each group, the volume of local anesthetic applied to&#xD;
      patients start with 30ml, and then decreased by 2.5ml for next patient when the previous&#xD;
      block is successful, otherwise increased by 2.5ml when failed,which is also called a&#xD;
      staircase up-and-down method usually applied in dose-finding research of nerve block. After&#xD;
      certain reflections of the local anesthetic volume sequential line graph, the minimum&#xD;
      effective volume could be calculated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</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>
    <intervention_model_description>costoclavicular group and paracoracoid group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MEV</measure>
    <time_frame>The anesthesia effect of the block with a specified volume fo local anesthetic will be assessed at 30 min after the nerve block finished, the MEV will be calculated after all.</time_frame>
    <description>minimum effective volume regional anesthetic need for a successful infraclavicular block</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>performance time</measure>
    <time_frame>from the time point when ultrasound probe touches with patients' skin to the end when local anesthetic is injected through the needle, which is usually up to ten minutes</time_frame>
    <description>time needed for the block performance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Brachial Plexus Block</condition>
  <arm_group>
    <arm_group_label>costoclavicular group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients in this group are assigned to receive ultrasound-guided costoclavicular infraclavicular block with 0.5% ropivacaine for upper limb surgery at elbow joint and below</description>
  </arm_group>
  <arm_group>
    <arm_group_label>paracoracoid group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients in this group are assigned to receive ultrasound-guided paracoracoid infraclavicular block with 0.5% ropivacaine for upper limb surgery at elbow joint and below</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>costoclavicular infraclavicular block</intervention_name>
    <description>Infraclavicular brachial plexus block will be performed through new costoclavicular space approach under realtime ultrasound guidance with 0.5% ropivacaine</description>
    <arm_group_label>costoclavicular group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>paracoracoid infraclavicular block</intervention_name>
    <description>Infraclavicular brachial plexus block will be performed through traditional paracoracoid approach under realtime ultrasound guidance with 0.5% ropivacaine</description>
    <arm_group_label>paracoracoid group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>All the nerve blocks will be performed under realtime ultrasound guidance</description>
    <arm_group_label>costoclavicular group</arm_group_label>
    <arm_group_label>paracoracoid group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>0.5% ropivacaine will be used for the brachial plexus block in both groups.</description>
    <arm_group_label>costoclavicular group</arm_group_label>
    <arm_group_label>paracoracoid group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA status 1 to 3&#xD;
&#xD;
          -  BMI 20-35&#xD;
&#xD;
          -  Scheduled for surgery at elbow joint or below&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to consent to the study&#xD;
&#xD;
          -  Preexisting neuropathy,coagulopathy,COPD&#xD;
&#xD;
          -  Hepatic or renal failure&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Prior surgery in infraclavicular region&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Mei, MD</last_name>
    <role>Study Director</role>
    <affiliation>Department of anesthesiology, Tongji hospital, Huazhong University of Science and Technology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wei Mei, MD</last_name>
    <phone>130-0616-2508</phone>
    <email>wmei@tjh.tjmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shuguang Yang, MD</last_name>
    <phone>150-7107-8161</phone>
    <email>yangsuperpro@163.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Albrecht E, Mermoud J, Fournier N, Kern C, Kirkham KR. A systematic review of ultrasound-guided methods for brachial plexus blockade. Anaesthesia. 2016 Feb;71(2):213-27. doi: 10.1111/anae.13347. Epub 2015 Dec 16.</citation>
    <PMID>26670119</PMID>
  </reference>
  <reference>
    <citation>Park SK, Lee SY, Kim WH, Park HS, Lim YJ, Bahk JH. Comparison of Supraclavicular and Infraclavicular Brachial Plexus Block: A Systemic Review of Randomized Controlled Trials. Anesth Analg. 2017 Feb;124(2):636-644. doi: 10.1213/ANE.0000000000001713.</citation>
    <PMID>27828793</PMID>
  </reference>
  <reference>
    <citation>Sauter AR, Smith HJ, Stubhaug A, Dodgson MS, Klaastad O. Use of magnetic resonance imaging to define the anatomical location closest to all three cords of the infraclavicular brachial plexus. Anesth Analg. 2006 Dec;103(6):1574-6. doi: 10.1213/01.ane.0000242529.96675.fd. Erratum In: Anesth Analg. 2007 Mar;104(3):562.</citation>
    <PMID>17122242</PMID>
  </reference>
  <reference>
    <citation>Tran DQ, Dugani S, Dyachenko A, Correa JA, Finlayson RJ. Minimum effective volume of lidocaine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):190-4. doi: 10.1097/AAP.0b013e31820d4266.</citation>
    <PMID>21270721</PMID>
  </reference>
  <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>
  </reference>
  <reference>
    <citation>Flohr-Madsen S, Ytrebo LM, Kregnes S, Wilsgaard T, Klaastad O. Minimum effective volume of ropivacaine 7.5 mg/ml for an ultrasound-guided infraclavicular brachial plexus block. Acta Anaesthesiol Scand. 2013 Apr;57(4):495-501. doi: 10.1111/aas.12078. Epub 2013 Feb 18.</citation>
    <PMID>23418881</PMID>
  </reference>
  <reference>
    <citation>Sala-Blanch X, Reina MA, Pangthipampai P, Karmakar MK. Anatomic Basis for Brachial Plexus Block at the Costoclavicular Space: A Cadaver Anatomic Study. Reg Anesth Pain Med. 2016 May-Jun;41(3):387-91. doi: 10.1097/AAP.0000000000000393.</citation>
    <PMID>27035461</PMID>
  </reference>
  <reference>
    <citation>Leurcharusmee P, Elgueta MF, Tiyaprasertkul W, Sotthisopha T, Samerchua A, Gordon A, Aliste J, Finlayson RJ, Tran DQH. A randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery. Can J Anaesth. 2017 Jun;64(6):617-625. doi: 10.1007/s12630-017-0842-z. Epub 2017 Feb 15.</citation>
    <PMID>28205117</PMID>
  </reference>
  <reference>
    <citation>Petrar SD, Seltenrich ME, Head SJ, Schwarz SK. Hemidiaphragmatic paralysis following ultrasound-guided supraclavicular versus infraclavicular brachial plexus blockade: a randomized clinical trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):133-8. doi: 10.1097/AAP.0000000000000215.</citation>
    <PMID>25650633</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 9, 2017</last_update_submitted>
  <last_update_submitted_qc>September 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Wei Mei</investigator_full_name>
    <investigator_title>PhD, MD Vice-Director of Anestheiology Department, Tongji hospital</investigator_title>
  </responsible_party>
  <keyword>costoclavicular</keyword>
  <keyword>paracoracoid</keyword>
  <keyword>brachial plexus</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/NCT03279679
org study id: TJ-IRB20170702
nct id: NCT03279679
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The costoclavicular space block technique is a new developed approach of ultrasound-guided
      infraclavicular brachial plexus block(USG-ICB) in last two years and has not been studied
      much yet. The paracoracoid approach serves as a standard and traditional method for USG-ICB
      in clinical practice, easy to learn and perform. The investigators set this parallel
      controlled dose-finding trial to work out the MEV with 0.5% ropivacaine of both two
      approaches above for forearm surgery and compare the performance time between them, providing
      reasonable evidence for clinical choice.
The costoclavicular space block technique is a new developed approach of ultrasound-guided
      infraclavicular brachial plexus block(USG-ICB) in last two years and has not been studied
      much yet. USG-ICB represents an attractive option for upper-limb surgery at or below the
      elbow joint with similar success rate and fewer adverse effects compared with
      ultrasound-guided supraclavicular block. The paracoracoid approach serves as a standard and
      traditional method for USG-ICB in clinical practice, easy to learn and perform. However, the
      minimum effective volume(MEV)of this approach has been studied by different investigators
      with different regional anesthetics or its mixture, and specially, the 95% MEV result of this
      approach is more than 30ml in all related researches which is still a large volume. According
      to the investigators' experience in using the costoclavicular space technique for forearm
      surgery, it usually can get a comparable sensation and motor block effect by no more than
      25ml. Recently, there was a clinical randomized control study which compared the
      costoclavicular and paracoracoid USG-ICB for upper limb surgery using a 35ml-mixture of 1%
      lidocaine-0.25% bupivacaine with epinephrine 5 ug/ml and came to the conclusions: two groups
      resulted in similar onset times and no intergroup difference were found in terms of
      performance time and success rate. However, 35ml is a much larger regional anesthetic volume
      than what we used in routine brachial plexus block. So, we set this parallel controlled
      dose-finding trial to work out the MEV with 0.5% ropivacaine of both approaches above for
      forearm surgery and compare the performance time between them, providing reasonable evidence
      for clinical choice. Patients enrolled in this study will be assigned to costoclavicular
      group and paracoracoid group and in each group, the volume of local anesthetic applied to
      patients start with 30ml, and then decreased by 2.5ml for next patient when the previous
      block is successful, otherwise increased by 2.5ml when failed,which is also called a
      staircase up-and-down method usually applied in dose-finding research of nerve block. After
      certain reflections of the local anesthetic volume sequential line graph, the minimum
      effective volume could be calculated.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: costoclavicular group and paracoracoid group
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: MEV
time frame: The anesthesia effect of the block with a specified volume fo local anesthetic will be assessed at 30 min after the nerve block finished, the MEV will be calculated after all.
description: minimum effective volume regional anesthetic need for a successful infraclavicular block
measure: performance time
time frame: from the time point when ultrasound probe touches with patients' skin to the end when local anesthetic is injected through the needle, which is usually up to ten minutes
description: time needed for the block performance
arm group label: costoclavicular group
arm group type: Experimental
description: patients in this group are assigned to receive ultrasound-guided costoclavicular infraclavicular block with 0.5% ropivacaine for upper limb surgery at elbow joint and below
arm group label: paracoracoid group
arm group type: Other
description: patients in this group are assigned to receive ultrasound-guided paracoracoid infraclavicular block with 0.5% ropivacaine for upper limb surgery at elbow joint and below
intervention type: Procedure
intervention name: costoclavicular infraclavicular block
description: Infraclavicular brachial plexus block will be performed through new costoclavicular space approach under realtime ultrasound guidance with 0.5% ropivacaine
arm group label: costoclavicular group
intervention type: Procedure
intervention name: paracoracoid infraclavicular block
description: Infraclavicular brachial plexus block will be performed through traditional paracoracoid approach under realtime ultrasound guidance with 0.5% ropivacaine
arm group label: paracoracoid group
intervention type: Device
intervention name: Ultrasound
description: All the nerve blocks will be performed under realtime ultrasound guidance
arm group label: costoclavicular group
arm group label: paracoracoid group
intervention type: Drug
intervention name: Ropivacaine
description: 0.5% ropivacaine will be used for the brachial plexus block in both groups.
arm group label: costoclavicular group
arm group label: paracoracoid group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Wei Mei, MD
role: Study Director
affiliation: Department of anesthesiology, Tongji hospital, Huazhong University of Science and Technology
last name: Wei Mei, MD
phone: 130-0616-2508
email: wmei@tjh.tjmu.edu.cn
last name: Shuguang Yang, MD
phone: 150-7107-8161
email: yangsuperpro@163.com
citation: Albrecht E, Mermoud J, Fournier N, Kern C, Kirkham KR. A systematic review of ultrasound-guided methods for brachial plexus blockade. Anaesthesia. 2016 Feb;71(2):213-27. doi: 10.1111/anae.13347. Epub 2015 Dec 16.
PMID: 26670119
citation: Park SK, Lee SY, Kim WH, Park HS, Lim YJ, Bahk JH. Comparison of Supraclavicular and Infraclavicular Brachial Plexus Block: A Systemic Review of Randomized Controlled Trials. Anesth Analg. 2017 Feb;124(2):636-644. doi: 10.1213/ANE.0000000000001713.
PMID: 27828793
citation: Sauter AR, Smith HJ, Stubhaug A, Dodgson MS, Klaastad O. Use of magnetic resonance imaging to define the anatomical location closest to all three cords of the infraclavicular brachial plexus. Anesth Analg. 2006 Dec;103(6):1574-6. doi: 10.1213/01.ane.0000242529.96675.fd. Erratum In: Anesth Analg. 2007 Mar;104(3):562.
PMID: 17122242
citation: Tran DQ, Dugani S, Dyachenko A, Correa JA, Finlayson RJ. Minimum effective volume of lidocaine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):190-4. doi: 10.1097/AAP.0b013e31820d4266.
PMID: 21270721
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: Flohr-Madsen S, Ytrebo LM, Kregnes S, Wilsgaard T, Klaastad O. Minimum effective volume of ropivacaine 7.5 mg/ml for an ultrasound-guided infraclavicular brachial plexus block. Acta Anaesthesiol Scand. 2013 Apr;57(4):495-501. doi: 10.1111/aas.12078. Epub 2013 Feb 18.
PMID: 23418881
citation: Sala-Blanch X, Reina MA, Pangthipampai P, Karmakar MK. Anatomic Basis for Brachial Plexus Block at the Costoclavicular Space: A Cadaver Anatomic Study. Reg Anesth Pain Med. 2016 May-Jun;41(3):387-91. doi: 10.1097/AAP.0000000000000393.
PMID: 27035461
citation: Leurcharusmee P, Elgueta MF, Tiyaprasertkul W, Sotthisopha T, Samerchua A, Gordon A, Aliste J, Finlayson RJ, Tran DQH. A randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery. Can J Anaesth. 2017 Jun;64(6):617-625. doi: 10.1007/s12630-017-0842-z. Epub 2017 Feb 15.
PMID: 28205117
citation: Petrar SD, Seltenrich ME, Head SJ, Schwarz SK. Hemidiaphragmatic paralysis following ultrasound-guided supraclavicular versus infraclavicular brachial plexus blockade: a randomized clinical trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):133-8. doi: 10.1097/AAP.0000000000000215.
PMID: 25650633
responsible party type: Principal Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Wei Mei
investigator title: PhD, MD Vice-Director of Anestheiology Department, Tongji hospital
mesh term: Ropivacaine
sharing ipd: No