<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/NCT02228759</url>
  </required_header>
  <id_info>
    <org_study_id>105097</org_study_id>
    <nct_id>NCT02228759</nct_id>
  </id_info>
  <brief_title>Ambulatory Continuous Adductor Canal Block to Facilitate Same Day Discharge Following Total Knee Arthroplasty: A Pilot Study</brief_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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients scheduled to undergo total knee arthroplasty will receive motor sparing knee blocks&#xD;
      with continuous adductor canal block along with multimodal analgesia started pre-operatively&#xD;
      and continued into the postoperative period. The study will evaluate the feasibility of home&#xD;
      discharge within the first 24 hours following total knee arthroplasty. We will also evaluate&#xD;
      the pain scores in the first 5 days following the surgery, causes of delayed discharge and&#xD;
      any adverse events.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>percentage of patients discharged at 23 hours based on a composite of various factors represented on a pre-determined criteria</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>first 24 hour pain scores</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>first 96 hour pain scores</measure>
    <time_frame>96 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue analgesic frequency</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total analgesic usage in the first 24 and 96 postoperative hours</measure>
    <time_frame>96 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Adductor canal block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study is an open label pilot study to determine the feasibility of same day discharge following total knee arthroplasty with the use of a fast track regimen employing motor sparing knee blocks. The study will be performed on 25 American Society of Anesthesiologists class (ASA) 1-2 patients satisfying the inclusion criteria and undergoing unilateral primary total knee arthroplasty. First and second patients of the day undergoing surgery between Monday to Thursday in a week will be accessed for the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Adductor canal block</intervention_name>
    <description>All patients will recieve fast tracking with reduced fasting times, multimodal analgesia and adductor canal block</description>
    <arm_group_label>Adductor canal block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and females of 40-70years of age&#xD;
&#xD;
          2. Scheduled to undergo unilateral primary total knee arthroplasty&#xD;
&#xD;
          3. ASA Class I, II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ASA 3, 4&#xD;
&#xD;
          2. Revision surgery&#xD;
&#xD;
          3. Narcotic dependent (opioid intake morphine equivalent &gt; 10 mg/ day for more than 3&#xD;
             months)&#xD;
&#xD;
          4. Other sources of chronic pain like fibromyalgia&#xD;
&#xD;
          5. Patients with associated significant cardiac, CNS or respiratory disease (poor&#xD;
             cardio-respiratory reserve)&#xD;
&#xD;
          6. Major conduction defects in EKG (bifascilular block, CHB); significant valvular heart&#xD;
             disease&#xD;
&#xD;
          7. Recent MI/ Stroke/ CHF (in the past 3 months)&#xD;
&#xD;
          8. BMI&gt; 35&#xD;
&#xD;
          9. Obstructive sleep apnea (AHI &gt; 15)&#xD;
&#xD;
         10. Patients with coexisting hematological disorder or with deranged coagulation&#xD;
             parameters.&#xD;
&#xD;
         11. Patients with pre-existing major organ dysfunction such as hepatic and renal failure.&#xD;
&#xD;
         12. Psychiatric illnesses&#xD;
&#xD;
         13. Uncontrolled diabetes mellitus&#xD;
&#xD;
         14. Lack of informed consent.&#xD;
&#xD;
         15. Allergy to any of the drugs used in the study&#xD;
&#xD;
         16. Preoperative neurological deficits&#xD;
&#xD;
         17. Use of walking aids preoperatively&#xD;
&#xD;
         18. Living alone (Lack of Chaperone/home help)&#xD;
&#xD;
         19. Language barrier&#xD;
&#xD;
         20. Contralateral leg weakness&#xD;
&#xD;
         21. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University hospital, London Health Sciences centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Ilfeld BM, Le LT, Meyer RS, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Berry LF, Spadoni EH, Gearen PF. Ambulatory continuous femoral nerve blocks decrease time to discharge readiness after tricompartment total knee arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2008 Apr;108(4):703-13. doi: 10.1097/ALN.0b013e318167af46.</citation>
    <PMID>18362603</PMID>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>March 7, 2017</last_update_submitted>
  <last_update_submitted_qc>March 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Sugantha Ganapathy</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Ambulatory home regional</keyword>
  <keyword>adductor canal block</keyword>
  <keyword>Postoperative pain</keyword>
  <keyword>total knee arthroplasty</keyword>
  <keyword>Home regional</keyword>
  <keyword>Fast track arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT02228759
org study id: 105097
nct id: NCT02228759
lead sponsor: 
has dmc: No
Patients scheduled to undergo total knee arthroplasty will receive motor sparing knee blocks
      with continuous adductor canal block along with multimodal analgesia started pre-operatively
      and continued into the postoperative period. The study will evaluate the feasibility of home
      discharge within the first 24 hours following total knee arthroplasty. We will also evaluate
      the pain scores in the first 5 days following the surgery, causes of delayed discharge and
      any adverse events.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: percentage of patients discharged at 23 hours based on a composite of various factors represented on a pre-determined criteria
time frame: 24 hours
measure: first 24 hour pain scores
time frame: 24 hours
measure: first 96 hour pain scores
time frame: 96 hours
measure: Rescue analgesic frequency
time frame: 24 hours
measure: total analgesic usage in the first 24 and 96 postoperative hours
time frame: 96 hours
arm group label: Adductor canal block
arm group type: Experimental
description: The study is an open label pilot study to determine the feasibility of same day discharge following total knee arthroplasty with the use of a fast track regimen employing motor sparing knee blocks. The study will be performed on 25 American Society of Anesthesiologists class (ASA) 1-2 patients satisfying the inclusion criteria and undergoing unilateral primary total knee arthroplasty. First and second patients of the day undergoing surgery between Monday to Thursday in a week will be accessed for the study.
intervention type: Procedure
intervention name: Adductor canal block
description: All patients will recieve fast tracking with reduced fasting times, multimodal analgesia and adductor canal block
arm group label: Adductor canal block
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Canada
citation: Ilfeld BM, Le LT, Meyer RS, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Berry LF, Spadoni EH, Gearen PF. Ambulatory continuous femoral nerve blocks decrease time to discharge readiness after tricompartment total knee arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2008 Apr;108(4):703-13. doi: 10.1097/ALN.0b013e318167af46.
PMID: 18362603
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Sugantha Ganapathy
investigator title: Principal Investigator
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee