<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/NCT02208245</url>
  </required_header>
  <id_info>
    <org_study_id>Infra Study</org_study_id>
    <nct_id>NCT02208245</nct_id>
  </id_info>
  <brief_title>Prospective Clinical Trial Comparing Infraclavicular Versus Axillary Approach to Brachial Plexus Block</brief_title>
  <official_title>Prospective Randomized Clinical Trial Comparing Infraclavicular Versus Axillary Approach to Brachial Plexus Block.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The brachial plexus block is an anesthetic technique often used for surgical procedures of&#xD;
      the upper limb. To get the brachial plexus block, several routes can be used, including the&#xD;
      axillary and infraclavicular approach.&#xD;
&#xD;
      Few studies have compared these techniques, considering the time to perform the block, the&#xD;
      onset time and success rate, with conflicting results. Furthermore, there is little&#xD;
      information in the literature comparing the length of postoperative analgesia provided by&#xD;
      these techniques.&#xD;
&#xD;
      Therefore, the investigators designed this study in order to elucidate the differences&#xD;
      between these two techniques to assist the anesthesiologist to choose the best of them in&#xD;
      clinical practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2014</start_date>
  <completion_date type="Anticipated">March 2015</completion_date>
  <primary_completion_date type="Anticipated">March 2015</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative analgesia</measure>
    <time_frame>first postoperative day</time_frame>
    <description>All patients will be contacted on the first postoperative day to tell the time of onset of pain postoperatively. The duration of postoperative analgesia is defined as the interval between the end of local anesthetic injection and the onset of postoperative pain reported by the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>local anesthetic pharmacokinetics</measure>
    <time_frame>During the procedure</time_frame>
    <description>Venous blood samples will be taken from some patients through a cannula. The samples will be used for the determination of serum levels achieved after ropivacaine blockade. Samples will be taken every 15 minutes during the first hour, every 30 minutes during the second hour and 4 hours after the blockade. These samples will be analyzed using the technique of high performance liquid chromatography coupled with mass spectrometry.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Scaphoid Fractures</condition>
  <condition>Distal Radius Fractures</condition>
  <condition>Wrist Injury Arthrodesis</condition>
  <arm_group>
    <arm_group_label>Ultrasound: Axillary block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For the axillary group, the ultrasound probe will be placed upright in the armpit to obtain a cross section of this region. After visualization of the nerves form the brachial plexus by ultrasound, 5 mL of ropivacaine 0.5% will be injected around each nerve to be blocked (median, ulnar, radial and musculocutaneous). If resistance to the injection of the solution is present or the patient complains of severe pain, the needle will be immediately repositioned.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultrasound: Infraclavicular block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For the infraclavicular group, the ultrasound probe will be placed in the infraclavicular region (the junction between the clavicle and the coracoid process) to obtain a cross-sectional imaging of the axillary artery. After visualization of the axillary artery by ultrasound, the block will be performed using the technique in plan for visualization of the needle. The needle is placed in position 6-8 hours of the artery, and 20 mL of ropivacaine 0.5% will be injected, observing a dispersal of local anesthetic around the artery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound: Axillary block</intervention_name>
    <description>Ultrasound guided axillary block</description>
    <arm_group_label>Ultrasound: Axillary block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound: Infraclavicular block</intervention_name>
    <description>Ultrasound guided infraclvicular block</description>
    <arm_group_label>Ultrasound: Infraclavicular block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>20 ml of ropivacaine 0,5% in both groups ( axillary block and infraclavicular block)</description>
    <arm_group_label>Ultrasound: Axillary block</arm_group_label>
    <arm_group_label>Ultrasound: Infraclavicular block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age older than 18 years and less than 70 years&#xD;
&#xD;
          -  consent informed signed by the patient&#xD;
&#xD;
          -  candidates for surgical intervention of scaphoid fractures, distal radius fractures&#xD;
             and wrist arthrodesis&#xD;
&#xD;
          -  American Society of Anesthesiology physical status I, II and III&#xD;
&#xD;
          -  body mass index (BMI) &lt;35 kg / m².&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive impairment or active psychiatric condition&#xD;
&#xD;
          -  infection at the puncture site&#xD;
&#xD;
          -  bleeding disorders&#xD;
&#xD;
          -  history of allergy to ropivacaine&#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>Maria Angela Tardelli, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Federal University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of Sao Paulo - Hospital Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04024002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Tran DQ, Russo G, Munoz L, Zaouter C, Finlayson RJ. A prospective, randomized comparison between ultrasound-guided supraclavicular, infraclavicular, and axillary brachial plexus blocks. Reg Anesth Pain Med. 2009 Jul-Aug;34(4):366-71. doi: 10.1097/AAP.0b013e3181ac7d18.</citation>
    <PMID>19574871</PMID>
  </reference>
  <reference>
    <citation>Song IA, Gil NS, Choi EY, Sim SE, Min SW, Ro YJ, Kim CS. Axillary approach versus the infraclavicular approach in ultrasound-guided brachial plexus block: comparison of anesthetic time. Korean J Anesthesiol. 2011 Jul;61(1):12-8. doi: 10.4097/kjae.2011.61.1.12. Epub 2011 Jul 21.</citation>
    <PMID>21860745</PMID>
  </reference>
  <reference>
    <citation>Lopez-Morales S, Moreno-Martin A, Leal del Ojo JD, Rodriguez-Huertas F. [Ultrasound-guided axillary block versus ultrasound-guided infraclavicular block for upper extremity surgery]. Rev Esp Anestesiol Reanim. 2013 Jun-Jul;60(6):313-9. doi: 10.1016/j.redar.2013.02.012. Epub 2013 May 15. Spanish.</citation>
    <PMID>23684374</PMID>
  </reference>
  <reference>
    <citation>Koscielniak-Nielsen ZJ, Frederiksen BS, Rasmussen H, Hesselbjerg L. A comparison of ultrasound-guided supraclavicular and infraclavicular blocks for upper extremity surgery. Acta Anaesthesiol Scand. 2009 May;53(5):620-6. doi: 10.1111/j.1399-6576.2009.01909.x.</citation>
    <PMID>19419356</PMID>
  </reference>
  <reference>
    <citation>Ootaki C, Hayashi H, Amano M. Ultrasound-guided infraclavicular brachial plexus block: an alternative technique to anatomical landmark-guided approaches. Reg Anesth Pain Med. 2000 Nov-Dec;25(6):600-4. doi: 10.1053/rapm.2000.18184.</citation>
    <PMID>11097667</PMID>
  </reference>
  <reference>
    <citation>Sandhu NS, Capan LM. Ultrasound-guided infraclavicular brachial plexus block. Br J Anaesth. 2002 Aug;89(2):254-9. doi: 10.1093/bja/aef186.</citation>
    <PMID>12378663</PMID>
  </reference>
  <reference>
    <citation>Tran DQ, Clemente A, Tran DQ, Finlayson RJ. A comparison between ultrasound-guided infraclavicular block using the &quot;double bubble&quot; sign and neurostimulation-guided axillary block. Anesth Analg. 2008 Sep;107(3):1075-8. doi: 10.1213/ane.0b013e31817ef259.</citation>
    <PMID>18713932</PMID>
  </reference>
  <reference>
    <citation>Arcand G, Williams SR, Chouinard P, Boudreault D, Harris P, Ruel M, Girard F. Ultrasound-guided infraclavicular versus supraclavicular block. Anesth Analg. 2005 Sep;101(3):886-890. doi: 10.1213/01.ANE.0000159168.69934.CC.</citation>
    <PMID>16116009</PMID>
  </reference>
  <reference>
    <citation>Ferraro LH, Takeda A, dos Reis Falcao LF, Rezende AH, Sadatsune EJ, Tardelli MA. Determination of the minimum effective volume of 0.5% bupivacaine for ultrasound-guided axillary brachial plexus block. Braz J Anesthesiol. 2014 Jan-Feb;64(1):49-53. doi: 10.1016/j.bjane.2013.03.014. Epub 2013 Dec 2.</citation>
    <PMID>24565388</PMID>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 2, 2014</last_update_submitted>
  <last_update_submitted_qc>August 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Leonardo Henrique Cunha Ferraro</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Radius Fractures</mesh_term>
    <mesh_term>Wrist Fractures</mesh_term>
    <mesh_term>Wrist Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</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/NCT02208245
org study id: Infra Study
nct id: NCT02208245
lead sponsor: 
has dmc: No
The brachial plexus block is an anesthetic technique often used for surgical procedures of
      the upper limb. To get the brachial plexus block, several routes can be used, including the
      axillary and infraclavicular approach.

      Few studies have compared these techniques, considering the time to perform the block, the
      onset time and success rate, with conflicting results. Furthermore, there is little
      information in the literature comparing the length of postoperative analgesia provided by
      these techniques.

      Therefore, the investigators designed this study in order to elucidate the differences
      between these two techniques to assist the anesthesiologist to choose the best of them in
      clinical practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: postoperative analgesia
time frame: first postoperative day
description: All patients will be contacted on the first postoperative day to tell the time of onset of pain postoperatively. The duration of postoperative analgesia is defined as the interval between the end of local anesthetic injection and the onset of postoperative pain reported by the patient.
measure: local anesthetic pharmacokinetics
time frame: During the procedure
description: Venous blood samples will be taken from some patients through a cannula. The samples will be used for the determination of serum levels achieved after ropivacaine blockade. Samples will be taken every 15 minutes during the first hour, every 30 minutes during the second hour and 4 hours after the blockade. These samples will be analyzed using the technique of high performance liquid chromatography coupled with mass spectrometry.
arm group label: Ultrasound: Axillary block
arm group type: Active Comparator
description: For the axillary group, the ultrasound probe will be placed upright in the armpit to obtain a cross section of this region. After visualization of the nerves form the brachial plexus by ultrasound, 5 mL of ropivacaine 0.5% will be injected around each nerve to be blocked (median, ulnar, radial and musculocutaneous). If resistance to the injection of the solution is present or the patient complains of severe pain, the needle will be immediately repositioned.
arm group label: Ultrasound: Infraclavicular block
arm group type: Active Comparator
description: For the infraclavicular group, the ultrasound probe will be placed in the infraclavicular region (the junction between the clavicle and the coracoid process) to obtain a cross-sectional imaging of the axillary artery. After visualization of the axillary artery by ultrasound, the block will be performed using the technique in plan for visualization of the needle. The needle is placed in position 6-8 hours of the artery, and 20 mL of ropivacaine 0.5% will be injected, observing a dispersal of local anesthetic around the artery.
intervention type: Device
intervention name: Ultrasound: Axillary block
description: Ultrasound guided axillary block
arm group label: Ultrasound: Axillary block
intervention type: Device
intervention name: Ultrasound: Infraclavicular block
description: Ultrasound guided infraclvicular block
arm group label: Ultrasound: Infraclavicular block
intervention type: Drug
intervention name: Ropivacaine
description: 20 ml of ropivacaine 0,5% in both groups ( axillary block and infraclavicular block)
arm group label: Ultrasound: Axillary block
arm group label: Ultrasound: Infraclavicular block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Maria Angela Tardelli, PhD
role: Study Director
affiliation: Federal University of São Paulo
facility: 
country: Brazil
citation: Tran DQ, Russo G, Munoz L, Zaouter C, Finlayson RJ. A prospective, randomized comparison between ultrasound-guided supraclavicular, infraclavicular, and axillary brachial plexus blocks. Reg Anesth Pain Med. 2009 Jul-Aug;34(4):366-71. doi: 10.1097/AAP.0b013e3181ac7d18.
PMID: 19574871
citation: Song IA, Gil NS, Choi EY, Sim SE, Min SW, Ro YJ, Kim CS. Axillary approach versus the infraclavicular approach in ultrasound-guided brachial plexus block: comparison of anesthetic time. Korean J Anesthesiol. 2011 Jul;61(1):12-8. doi: 10.4097/kjae.2011.61.1.12. Epub 2011 Jul 21.
PMID: 21860745
citation: Lopez-Morales S, Moreno-Martin A, Leal del Ojo JD, Rodriguez-Huertas F. [Ultrasound-guided axillary block versus ultrasound-guided infraclavicular block for upper extremity surgery]. Rev Esp Anestesiol Reanim. 2013 Jun-Jul;60(6):313-9. doi: 10.1016/j.redar.2013.02.012. Epub 2013 May 15. Spanish.
PMID: 23684374
citation: Koscielniak-Nielsen ZJ, Frederiksen BS, Rasmussen H, Hesselbjerg L. A comparison of ultrasound-guided supraclavicular and infraclavicular blocks for upper extremity surgery. Acta Anaesthesiol Scand. 2009 May;53(5):620-6. doi: 10.1111/j.1399-6576.2009.01909.x.
PMID: 19419356
citation: Ootaki C, Hayashi H, Amano M. Ultrasound-guided infraclavicular brachial plexus block: an alternative technique to anatomical landmark-guided approaches. Reg Anesth Pain Med. 2000 Nov-Dec;25(6):600-4. doi: 10.1053/rapm.2000.18184.
PMID: 11097667
citation: Sandhu NS, Capan LM. Ultrasound-guided infraclavicular brachial plexus block. Br J Anaesth. 2002 Aug;89(2):254-9. doi: 10.1093/bja/aef186.
PMID: 12378663
citation: Tran DQ, Clemente A, Tran DQ, Finlayson RJ. A comparison between ultrasound-guided infraclavicular block using the "double bubble" sign and neurostimulation-guided axillary block. Anesth Analg. 2008 Sep;107(3):1075-8. doi: 10.1213/ane.0b013e31817ef259.
PMID: 18713932
citation: Arcand G, Williams SR, Chouinard P, Boudreault D, Harris P, Ruel M, Girard F. Ultrasound-guided infraclavicular versus supraclavicular block. Anesth Analg. 2005 Sep;101(3):886-890. doi: 10.1213/01.ANE.0000159168.69934.CC.
PMID: 16116009
citation: Ferraro LH, Takeda A, dos Reis Falcao LF, Rezende AH, Sadatsune EJ, Tardelli MA. Determination of the minimum effective volume of 0.5% bupivacaine for ultrasound-guided axillary brachial plexus block. Braz J Anesthesiol. 2014 Jan-Feb;64(1):49-53. doi: 10.1016/j.bjane.2013.03.014. Epub 2013 Dec 2.
PMID: 24565388
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Leonardo Henrique Cunha Ferraro
investigator title: MD
mesh term: Fractures, Bone
mesh term: Radius Fractures
mesh term: Wrist Fractures
mesh term: Wrist Injuries
mesh term: Ropivacaine