<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/NCT03268837</url>
  </required_header>
  <id_info>
    <org_study_id>109624</org_study_id>
    <nct_id>NCT03268837</nct_id>
  </id_info>
  <brief_title>Programmed Intermittent Bolus During Continuous Interscalene Nerve Block for Shoulder Arthroplasty</brief_title>
  <official_title>Programmed Intermittent Bolus for Infusion of Local Anesthetic During Continuous Interscalene Nerve Blockade for Total Shoulder Arthroplasty: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A new infusion strategy named the 'programmed intermittent bolus' (PIB) technique delivers&#xD;
      the hourly dose within minutes compared to the traditional infusion that delivers such dose&#xD;
      over an hour. The PIB technique has demonstrated superior patient satisfaction and reduced&#xD;
      local anesthetic consumption when utilized for pain control during labour and delivery.&#xD;
      However, it is not known if the PIB technique gives any benefits during a continuous nerve&#xD;
      block in other settings. The aim of this randomized controlled trial (RCT) is to elucidate if&#xD;
      PIB is better than (traditional) continuous infusion for postoperative analgesia in patients&#xD;
      receiving a continuous nerve block for total shoulder arthroplasty with respect to pain&#xD;
      control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Local anesthetics are often given in a continuous fashion to block specific nerves after an&#xD;
      operation for pain control. A new infusion strategy named the 'programmed intermittent bolus'&#xD;
      (PIB) technique delivers the hourly dose within minutes compared to the traditional infusion&#xD;
      that delivers such dose over an hour. The PIB technique has demonstrated superior patient&#xD;
      satisfaction and reduced local anesthetic consumption when utilized for pain control during&#xD;
      labour and delivery. However, it is not known if the PIB technique gives any benefits during&#xD;
      a continuous nerve block in other settings. The aim of this randomized controlled trial (RCT)&#xD;
      is to elucidate if PIB is better than (traditional) continuous infusion for postoperative&#xD;
      analgesia in patients receiving a continuous nerve block for total shoulder arthroplasty with&#xD;
      respect to pain control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2022</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score on 11 point (0 - 10) numeric rating scale</measure>
    <time_frame>FIrst 24 hour since the operation</time_frame>
    <description>Postoperative pain score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Local anesthetic consumption</measure>
    <time_frame>36 hours (or until block discontinuation)</time_frame>
    <description>The total dose of local anesthetic used until the block is discontinued</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid consumption</measure>
    <time_frame>48 hours (or until discharge)</time_frame>
    <description>The total amount of opioids consumed will be recorded until the patient is discharged</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effect</measure>
    <time_frame>through to patient discharge, on average 48 hours</time_frame>
    <description>nausea, voting, pruritus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>through to patient discharge, on average 48 hours</time_frame>
    <description>100 mm visual analogue scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Block complication</measure>
    <time_frame>through to patient discharge, on average 48 hours</time_frame>
    <description>persistent motor or sensory block, dyspnea, hoarseness, Horner syndrome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Shoulder Arthroplasty</condition>
  <condition>Shoulder Osteoarthritis</condition>
  <condition>Pain Management</condition>
  <arm_group>
    <arm_group_label>Programmed Intermittent Bolus (PIB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the experimental group, patients will receive 5 mL of the study solution as a bolus every hour via a PIB-capable infusion pump.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous Infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control (standard care) group will receive the study solution at a rate of 5mL/h continuously via the current infusion pump.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Programmed Intermittent Bolus</intervention_name>
    <description>The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide programmed intermittent bolus for the interscalene block.</description>
    <arm_group_label>Programmed Intermittent Bolus (PIB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Infusion</intervention_name>
    <description>The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide continuous infusion for the interscalene block.</description>
    <arm_group_label>Continuous Infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) Physical Status I to III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) &gt; 40&#xD;
&#xD;
          -  Not able to communicate in ENglish&#xD;
&#xD;
          -  Unable to obtain consent&#xD;
&#xD;
          -  Infection over site of placement&#xD;
&#xD;
          -  Severe respiratory disease&#xD;
&#xD;
          -  Cognitive or psychiatric history that would make it difficult to assess pain score&#xD;
&#xD;
          -  Complex regional pain syndrome&#xD;
&#xD;
          -  Chronic pain condition such as fibromyalgia, neuropathic pain&#xD;
&#xD;
          -  Preoperative opioid use greater than the equivalent of morphine 50 mg PO daily&#xD;
&#xD;
          -  Allergy to any of the study drug&#xD;
&#xD;
          -  Coagulopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bill Lin, FRCPC</last_name>
    <phone>+15196466000</phone>
    <phone_ext>64219</phone_ext>
    <email>cheng.lin@lhsc.on.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>St. Joseph's Health Care London</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4V2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cheng Lin, FRCPC</last_name>
      <phone>5196858500</phone>
      <phone_ext>15896</phone_ext>
      <email>cheng.lin@lhsc.on.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>Chong MA, Wang Y, Dhir S, Lin C. Programmed intermittent peripheral nerve local anesthetic bolus compared with continuous infusions for postoperative analgesia: A systematic review and meta-analysis. J Clin Anesth. 2017 Nov;42:69-76. doi: 10.1016/j.jclinane.2017.08.018. Epub 2017 Aug 19.</citation>
    <PMID>28830037</PMID>
  </results_reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Shalini Dhir</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT03268837
org study id: 109624
nct id: NCT03268837
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
A new infusion strategy named the 'programmed intermittent bolus' (PIB) technique delivers
      the hourly dose within minutes compared to the traditional infusion that delivers such dose
      over an hour. The PIB technique has demonstrated superior patient satisfaction and reduced
      local anesthetic consumption when utilized for pain control during labour and delivery.
      However, it is not known if the PIB technique gives any benefits during a continuous nerve
      block in other settings. The aim of this randomized controlled trial (RCT) is to elucidate if
      PIB is better than (traditional) continuous infusion for postoperative analgesia in patients
      receiving a continuous nerve block for total shoulder arthroplasty with respect to pain
      control.
Local anesthetics are often given in a continuous fashion to block specific nerves after an
      operation for pain control. A new infusion strategy named the 'programmed intermittent bolus'
      (PIB) technique delivers the hourly dose within minutes compared to the traditional infusion
      that delivers such dose over an hour. The PIB technique has demonstrated superior patient
      satisfaction and reduced local anesthetic consumption when utilized for pain control during
      labour and delivery. However, it is not known if the PIB technique gives any benefits during
      a continuous nerve block in other settings. The aim of this randomized controlled trial (RCT)
      is to elucidate if PIB is better than (traditional) continuous infusion for postoperative
      analgesia in patients receiving a continuous nerve block for total shoulder arthroplasty with
      respect to pain control.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain score on 11 point (0 - 10) numeric rating scale
time frame: FIrst 24 hour since the operation
description: Postoperative pain score
measure: Local anesthetic consumption
time frame: 36 hours (or until block discontinuation)
description: The total dose of local anesthetic used until the block is discontinued
measure: Opioid consumption
time frame: 48 hours (or until discharge)
description: The total amount of opioids consumed will be recorded until the patient is discharged
measure: Side effect
time frame: through to patient discharge, on average 48 hours
description: nausea, voting, pruritus
measure: patient satisfaction
time frame: through to patient discharge, on average 48 hours
description: 100 mm visual analogue scale
measure: Block complication
time frame: through to patient discharge, on average 48 hours
description: persistent motor or sensory block, dyspnea, hoarseness, Horner syndrome
arm group label: Programmed Intermittent Bolus (PIB)
arm group type: Experimental
description: For the experimental group, patients will receive 5 mL of the study solution as a bolus every hour via a PIB-capable infusion pump.
arm group label: Continuous Infusion
arm group type: Active Comparator
description: The control (standard care) group will receive the study solution at a rate of 5mL/h continuously via the current infusion pump.
intervention type: Device
intervention name: Programmed Intermittent Bolus
description: The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide programmed intermittent bolus for the interscalene block.
arm group label: Programmed Intermittent Bolus (PIB)
intervention type: Device
intervention name: Continuous Infusion
description: The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide continuous infusion for the interscalene block.
arm group label: Continuous Infusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bill Lin, FRCPC
phone: +15196466000
phone ext: 64219
email: cheng.lin@lhsc.on.ca
facility: 
status: Recruiting
contact: 
country: Canada
citation: Chong MA, Wang Y, Dhir S, Lin C. Programmed intermittent peripheral nerve local anesthetic bolus compared with continuous infusions for postoperative analgesia: A systematic review and meta-analysis. J Clin Anesth. 2017 Nov;42:69-76. doi: 10.1016/j.jclinane.2017.08.018. Epub 2017 Aug 19.
PMID: 28830037
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Shalini Dhir
investigator title: Associate Professor
mesh term: Osteoarthritis
sharing ipd: No