<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/NCT02210429</url>
  </required_header>
  <id_info>
    <org_study_id>2014-15849</org_study_id>
    <nct_id>NCT02210429</nct_id>
  </id_info>
  <brief_title>Supraclavicular Blocks for Post-Operative Pain Control in Supracondylar Fracture Fixation, a Retrospective Analysis of Single Shot Catheter Techniques</brief_title>
  <official_title>Supraclavicular Blocks for Post-Operative Pain Control in Supracondylar Fracture Fixation, a Retrospective Analysis of Single Shot Catheter Techniques</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ann &amp; Robert H Lurie Children's Hospital of Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We hypothesize that patients who receive a supraclavicular block via Angiocath, placed&#xD;
      intra-operatively and dosed post-operatively following neurologic examination, will have&#xD;
      lower pain scores, lower use of intravenous morphine equivalents in the post-anesthesia care&#xD;
      unit, and lower rates of intervention for post-operative nausea and vomiting. We also&#xD;
      hypothesize that patients receiving this nerve block had the same rates of nerve damage as&#xD;
      the patients who did not receive a block and that there will be no demonstrable safety&#xD;
      concerns with this block.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2009</start_date>
  <completion_date type="Anticipated">November 2015</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative opioid use</measure>
    <time_frame>24 hours</time_frame>
    <description>Total doses</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anti-emetic drug use</measure>
    <time_frame>24 hours</time_frame>
    <description>Total doses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of nerve damage or compartment syndrome</measure>
    <time_frame>1 month</time_frame>
    <description>Evaluated by surgeon at follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score</measure>
    <time_frame>24 hours</time_frame>
    <description>Using Visual Analog Scale and FLACC pain scale (for younger children) we will compare pain scores in the various groups.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Acute Pain</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>IV Opioids</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Supraclavicular Single-Shot Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Supraclavicular Catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Supraclavicular Angiocath</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Elbow Fracture Fixation</intervention_name>
    <arm_group_label>IV Opioids</arm_group_label>
    <arm_group_label>Supraclavicular Angiocath</arm_group_label>
    <arm_group_label>Supraclavicular Catheter</arm_group_label>
    <arm_group_label>Supraclavicular Single-Shot Block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age under 18&#xD;
&#xD;
          -  Undergoing supracondylar fracture fixation in operating room&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incomplete or inaccessable chart data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Santhanam Suresh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ann &amp; Robert H Lurie Children's Hospital of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611-2605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Suresh S, Sarwark JP, Bhalla T, Janicki J. Performing US-guided nerve blocks in the postanesthesia care unit (PACU) for upper extremity fractures: is this feasible in children? Paediatr Anaesth. 2009 Dec;19(12):1238-40. doi: 10.1111/j.1460-9592.2009.03182.x. No abstract available.</citation>
    <PMID>20017868</PMID>
  </reference>
  <reference>
    <citation>Steinfeldt J, Robison T, Przybylo HJ. Placement of an US-guided supraclavicular block postoperatively in children: can we make this easy? Paediatr Anaesth. 2010 Aug;20(8):780-1. doi: 10.1111/j.1460-9592.2010.03355.x. No abstract available.</citation>
    <PMID>20670249</PMID>
  </reference>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 3, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>July 27, 2015</last_update_submitted>
  <last_update_submitted_qc>July 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Supraclavicular Block</keyword>
  <keyword>Supraclavicular Catheter</keyword>
  <keyword>Pediatric Anesthesia</keyword>
  <keyword>Regional Anesthesia</keyword>
  <keyword>Supracondylar Elbow Fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Acute Pain</mesh_term>
  </condition_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/NCT02210429
org study id: 2014-15849
nct id: NCT02210429
lead sponsor: 
has dmc: No
We hypothesize that patients who receive a supraclavicular block via Angiocath, placed
      intra-operatively and dosed post-operatively following neurologic examination, will have
      lower pain scores, lower use of intravenous morphine equivalents in the post-anesthesia care
      unit, and lower rates of intervention for post-operative nausea and vomiting. We also
      hypothesize that patients receiving this nerve block had the same rates of nerve damage as
      the patients who did not receive a block and that there will be no demonstrable safety
      concerns with this block.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Post-operative opioid use
time frame: 24 hours
description: Total doses
measure: Anti-emetic drug use
time frame: 24 hours
description: Total doses
measure: Incidence of nerve damage or compartment syndrome
time frame: 1 month
description: Evaluated by surgeon at follow up.
measure: Pain Score
time frame: 24 hours
description: Using Visual Analog Scale and FLACC pain scale (for younger children) we will compare pain scores in the various groups.
arm group label: IV Opioids
arm group type: Active Comparator
arm group label: Supraclavicular Single-Shot Block
arm group type: Active Comparator
arm group label: Supraclavicular Catheter
arm group type: Active Comparator
arm group label: Supraclavicular Angiocath
arm group type: Active Comparator
intervention type: Procedure
intervention name: Elbow Fracture Fixation
arm group label: IV Opioids
arm group label: Supraclavicular Angiocath
arm group label: Supraclavicular Catheter
arm group label: Supraclavicular Single-Shot Block
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Santhanam Suresh, MD
role: Principal Investigator
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
facility: 
country: United States
citation: Suresh S, Sarwark JP, Bhalla T, Janicki J. Performing US-guided nerve blocks in the postanesthesia care unit (PACU) for upper extremity fractures: is this feasible in children? Paediatr Anaesth. 2009 Dec;19(12):1238-40. doi: 10.1111/j.1460-9592.2009.03182.x. No abstract available.
PMID: 20017868
citation: Steinfeldt J, Robison T, Przybylo HJ. Placement of an US-guided supraclavicular block postoperatively in children: can we make this easy? Paediatr Anaesth. 2010 Aug;20(8):780-1. doi: 10.1111/j.1460-9592.2010.03355.x. No abstract available.
PMID: 20670249
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Acute Pain