<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/NCT03038425</url>
  </required_header>
  <id_info>
    <org_study_id>20160937</org_study_id>
    <nct_id>NCT03038425</nct_id>
  </id_info>
  <brief_title>Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients?</brief_title>
  <official_title>Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Ottawa Hospital Academic Medical Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a randomized, double-blinded pilot study to determine whether patients undergoing&#xD;
      ambulatory total knee arthroplasty (TKA) using a subvastus approach benefit from the addition&#xD;
      of a continuous adductor canal nerve block (cACB) catheter along with an existing multimodal&#xD;
      approach to postoperative analgesia. Outcomes include the 15-item Quality of Recovery Scale&#xD;
      (QoR-15) (Miles 2016), pain scores, opioid consumption, opioid-free days, functional outcome&#xD;
      as measured by the Time Up and Go (TUG) test, patient satisfaction, patient's rating of&#xD;
      catheter effectiveness, and complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2017</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Recovery Scale 15 (QoR-15)</measure>
    <time_frame>at 4pm on post-operative day (POD) 1</time_frame>
    <description>QoR-15 is a validated scale calculated from a 15-question patient questionnaire. It is an aggregate score that evaluates recovery after surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Recovery Scale 15 (QoR-15)</measure>
    <time_frame>POD 2-4 + 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score at rest</measure>
    <time_frame>POD 1-4 + 7</time_frame>
    <description>Patients will rate their pain on a scale of 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score with activity</measure>
    <time_frame>POD 1-4 + 7</time_frame>
    <description>Patients will rate their pain on a scale of 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tapentadol consumption</measure>
    <time_frame>POD 1-4 + 7</time_frame>
    <description>Daily tapentadol use in milligrams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>POD 1-4 + 7</time_frame>
    <description>Patients will be asked &quot;are you satisfied with your pain control&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs - blood pressure, heart rate, oxygen saturation</measure>
    <time_frame>twice daily POD 1-4</time_frame>
    <description>These measurements will be obtained via post-operative home monitoring system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-rated catheter effectiveness</measure>
    <time_frame>POD 1-4</time_frame>
    <description>Patients will be asked &quot;do you think the nerve block catheter is helpful? Rate on a 5-point scale&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catheter specific complications</measure>
    <time_frame>POD 1-4</time_frame>
    <description>Patients will be asked daily to report these potential nerve block catheter related issues: (1) leakage around the dressing (2) occlusion/blockage of the pump (3) inadvertent catheter disconnection (4) swelling around the catheter site (5) bleeding or bruising around the catheter site (6) other complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peri-operative complications</measure>
    <time_frame>POD 30</time_frame>
    <description>Significant peri-operative complications resulting in return to emergency department, re-admission after discharge, or return to operating room will be reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed-up-and-go (TUG) test</measure>
    <time_frame>POD 14</time_frame>
    <description>TUG is a validated test to assess a person's mobility. It has been used to evaluate functional recovery after orthopedic surgeries. This will be administered on POD 14 at the surgeon's office during the post-operative follow-up visit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Arthroplasty, Replacement, Knee</condition>
  <condition>Nerve Block</condition>
  <condition>Anesthesia, Regional</condition>
  <condition>Ambulatory Surgical Procedures</condition>
  <arm_group>
    <arm_group_label>Saline infusion</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in this group will receive normal saline infusion (5ml/hr, patient controlled bolus 5ml, lockout 30min) in the adductor canal, starting in PACU on post-operative day 0 and continuing for 96 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ropivacaine infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group will receive ropivacaine 0.2% infusion (5ml/hr, patient controlled bolus 5ml, lockout 30min) in the adductor canal, starting in PACU on post-operative day 0 and continuing for 96 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>This is the placebo intervention - normal saline infused in the adductor canal via a catheter. There are no anticipated therapeutic effect</description>
    <arm_group_label>Saline infusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>This is the treatment intervention - ropivacaine 0.2% infused in the adductor canal via a catheter. This will provide analgesia to the knee after TKA</description>
    <arm_group_label>Ropivacaine infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patient characteristics suitable for subvastus approach as determined by single&#xD;
             surgeon&#xD;
&#xD;
          2. patients willing to undergo ambulatory surgery&#xD;
&#xD;
          3. ability to read and verbally communicate via either English or French&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. age &gt; 80&#xD;
&#xD;
          2. driving distance greater than 1 hour from hospital&#xD;
&#xD;
          3. no willing caregiver at home on night of surgery&#xD;
&#xD;
          4. renal failure requiring dialysis&#xD;
&#xD;
          5. Insulin-dependent diabetes mellitus&#xD;
&#xD;
          6. BMI &gt; 45&#xD;
&#xD;
          7. allergy to study medications&#xD;
&#xD;
          8. pre-existing neurologic deficit involving the ipsilateral limb&#xD;
&#xD;
          9. chronic high dose opioid use (defined as &gt;200mg/day of morphine equivalent for over 2&#xD;
             weeks).&#xD;
&#xD;
         10. inability to use or manage cACB catheter and pump independently at home&#xD;
&#xD;
         11. inability or refusal to cryocompressive therapy device.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick BY Wong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ottawa Hospital, University of Ottawa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital, General Campus</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>December 21, 2020</last_update_submitted>
  <last_update_submitted_qc>December 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03038425
org study id: 20160937
nct id: NCT03038425
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized, double-blinded pilot study to determine whether patients undergoing
      ambulatory total knee arthroplasty (TKA) using a subvastus approach benefit from the addition
      of a continuous adductor canal nerve block (cACB) catheter along with an existing multimodal
      approach to postoperative analgesia. Outcomes include the 15-item Quality of Recovery Scale
      (QoR-15) (Miles 2016), pain scores, opioid consumption, opioid-free days, functional outcome
      as measured by the Time Up and Go (TUG) test, patient satisfaction, patient's rating of
      catheter effectiveness, and complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Quality of Recovery Scale 15 (QoR-15)
time frame: at 4pm on post-operative day (POD) 1
description: QoR-15 is a validated scale calculated from a 15-question patient questionnaire. It is an aggregate score that evaluates recovery after surgery.
measure: Quality of Recovery Scale 15 (QoR-15)
time frame: POD 2-4 + 7
measure: Pain score at rest
time frame: POD 1-4 + 7
description: Patients will rate their pain on a scale of 0-10
measure: Pain score with activity
time frame: POD 1-4 + 7
description: Patients will rate their pain on a scale of 0-10
measure: Tapentadol consumption
time frame: POD 1-4 + 7
description: Daily tapentadol use in milligrams
measure: Patient satisfaction
time frame: POD 1-4 + 7
description: Patients will be asked "are you satisfied with your pain control"
measure: Vital signs - blood pressure, heart rate, oxygen saturation
time frame: twice daily POD 1-4
description: These measurements will be obtained via post-operative home monitoring system
measure: Patient-rated catheter effectiveness
time frame: POD 1-4
description: Patients will be asked "do you think the nerve block catheter is helpful? Rate on a 5-point scale"
measure: Catheter specific complications
time frame: POD 1-4
description: Patients will be asked daily to report these potential nerve block catheter related issues: (1) leakage around the dressing (2) occlusion/blockage of the pump (3) inadvertent catheter disconnection (4) swelling around the catheter site (5) bleeding or bruising around the catheter site (6) other complications
measure: Peri-operative complications
time frame: POD 30
description: Significant peri-operative complications resulting in return to emergency department, re-admission after discharge, or return to operating room will be reported
measure: Timed-up-and-go (TUG) test
time frame: POD 14
description: TUG is a validated test to assess a person's mobility. It has been used to evaluate functional recovery after orthopedic surgeries. This will be administered on POD 14 at the surgeon's office during the post-operative follow-up visit
arm group label: Saline infusion
arm group type: Placebo Comparator
description: Participants in this group will receive normal saline infusion (5ml/hr, patient controlled bolus 5ml, lockout 30min) in the adductor canal, starting in PACU on post-operative day 0 and continuing for 96 hours
arm group label: Ropivacaine infusion
arm group type: Active Comparator
description: Participants in this group will receive ropivacaine 0.2% infusion (5ml/hr, patient controlled bolus 5ml, lockout 30min) in the adductor canal, starting in PACU on post-operative day 0 and continuing for 96 hours
intervention type: Drug
intervention name: Normal Saline
description: This is the placebo intervention - normal saline infused in the adductor canal via a catheter. There are no anticipated therapeutic effect
arm group label: Saline infusion
intervention type: Drug
intervention name: Ropivacaine
description: This is the treatment intervention - ropivacaine 0.2% infused in the adductor canal via a catheter. This will provide analgesia to the knee after TKA
arm group label: Ropivacaine infusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Patrick BY Wong, MD
role: Principal Investigator
affiliation: The Ottawa Hospital, University of Ottawa
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Ropivacaine
sharing ipd: Undecided