xml: <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/NCT05962970</url>
    </required_header>
    <id_info>
      <org_study_id>21-0041-A</org_study_id>
      <nct_id>NCT05962970</nct_id>
    </id_info>
    <brief_title>Continuous Adductor Canal Block in Fast Track Total Knee Arthroplasty</brief_title>
    <acronym>CACB</acronym>
    <official_title>Continuous Adductor Canal Block in Fast Track Total Knee Arthroplasty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Total knee arthroplasty (TKA) is a frequent performed surgery. Many institutions are&#xD;
        implementing fast track programs for this surgery and adequate pain management is an&#xD;
        important feature. Analgesic duration of single shot nerve blocks is limited to no more than&#xD;
        24h. Conversely, the use of continuous nerve block (CNB) through a perineural catheter and&#xD;
        infusion of local anesthetic may increase duration of analgesia and provide better outcomes.&#xD;
        The purpose of this study is to evaluate effectiveness and safety of using CNB in patients&#xD;
        undergoing ambulatory TKA, and its effects on patients' quality of recovery. Investigators&#xD;
        hypothesize that continuous adductor canal block would lead to decrease in opioid consumption&#xD;
        in patients undergoing fast track TKA.&#xD;
  &#xD;
        Significance There are no published prospective randomized controlled trials to assess&#xD;
        patient's reported quality of recovery after receiving CACB in same day primary knee&#xD;
        arthroplasties. As this is a frequent type of surgery and has the prediction to increase its&#xD;
        incidence for the next years, there is significant importance in investigations about&#xD;
        interventions which may improve its recovery in a fast track regime. A postoperative&#xD;
        analgesic technique that offers better pain control, has less adverse effects, reduces the&#xD;
        opioid analgesia requirement and is safe to be used in a fast track setting may have&#xD;
        additional impact on decreasing health care cost and may lead to an enhanced recovery and&#xD;
        better quality of life.&#xD;
  &#xD;
        Objectives To evaluate effectiveness and safety of using CACB in patients undergoing&#xD;
        ambulatory TKA, in comparison to SACB. Primary objective is opioid consumption (in oral&#xD;
        morphine equivalent doses) Secondary objectives are to evaluate postoperative QoR-15 scores&#xD;
        (10), pain scores, opioid-induced adverse effects (measured via validated opioid symptom&#xD;
        distress scale), postoperative functional status, complications relating to the perineural&#xD;
        catheter and readmissions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objectives The aim of this study is to examine the effect of CACB on decreasing opioid&#xD;
        consumption, increasing the Quality of Recovery (measured via QoR-15) total score and&#xD;
        decreasing opioid-related side effects. Investigators will also assess the rate of&#xD;
        readmissions in primary knee arthroplasty patients.&#xD;
  &#xD;
        Rationale&#xD;
  &#xD;
        Pain management in knee arthroplasty patients poses unique challenges for the&#xD;
        anesthesiologist, especially in the immediate post-operative period. Early postoperative&#xD;
        analgesia is limited to a unimodality of intravenous opioids. Recently, adductor canal blocks&#xD;
        have started to replace femoral blocks, as this technique can provide similar analgesic&#xD;
        results while avoiding the quadriceps muscle weakness associated with femoral nerve blocks.&#xD;
        The use of a continuous adductor canal catheter in the post-discharge phase shows promising&#xD;
        as the next step in knee arthroplasty pain management allowing for shorter lengths of stay or&#xD;
        even same day discharge (3).&#xD;
  &#xD;
        Significance and Innovation&#xD;
  &#xD;
        Total knee arthroplasty (TKA) is the second most common inpatient surgery in the U.S. and&#xD;
        Canada, and is associated with severe postoperative pain, limiting early ambulation and&#xD;
        optimal functional recovery. Perioperative opioid use has been linked with many adverse&#xD;
        outcomes including opioid dependence. This study aims to demonstrate the utility of CACB as&#xD;
        an adjunct strategy to reduce opioid consumption and improve quality of recovery in primary&#xD;
        knee arthroplasty patients. The innovation in this approach lies not only in less opioid&#xD;
        consumption and opioid induced side effects but also in reducing the burden of postoperative&#xD;
        pain, leading to an enhanced recovery and better quality of life. Establishing the safeness&#xD;
        of this method in an outpatient setting may have the additional impact of decreasing health&#xD;
        care costs and may lead to reduce opioid prescriptions on discharge from the hospital.&#xD;
  &#xD;
        This will be the first study assessing patient's reported quality of recovery after receiving&#xD;
        CACB for primary knee arthroplasties. Investigators expect that that the use of CACB will&#xD;
        improve patients' quality of recovery, alleviate pain and also reduce opioid consumption and&#xD;
        side effects.&#xD;
  &#xD;
        Methodology&#xD;
  &#xD;
        This will be a prospective, randomized double blind placebo controlled clinical trial. There&#xD;
        will be two arms of treatment: intervention and control group. Preoperatively patients will&#xD;
        be allocated at random to receive either Continuous adductor canal block (CACB) (intervention&#xD;
        group) or sham continuous adductor canal block (ShACB) (control group).&#xD;
  &#xD;
        Work Plan&#xD;
  &#xD;
        This prospective trial would include unilateral primary TKA done under Fastrack protocol. The&#xD;
        subjects will have their surgeries booked in advance and they will be submitted to the pre&#xD;
        anesthesia consult at the Pre-Admission Unit a few days before the surgery. The study&#xD;
        proposal will be explained to the patients at time of preadmission consult. They will receive&#xD;
        a booklet with information about the study and the Consent Form that they will bring home&#xD;
        with them. Patients will be randomized to one of the two groups using a computer-generated&#xD;
        random numbers table. The elastomeric pumps to be used connected to the catheter will be&#xD;
        previously prepared by hospital pharmacy, accordingly to the randomization made and the&#xD;
        subject study number, with no identification of the content (NaCl 0.9% or Ropivacaine 0.2%).&#xD;
        All patients will receive the same perioperative management. The only difference will be the&#xD;
        postoperative continuous perineural infusion: the CACB group will receive an infusion of 0.2%&#xD;
        ropivacaine 5mL/h and ShACB group will receive an infusion of NaCl 0.9% 5mL/h. Patients will&#xD;
        initially be brought to a dedicated block room where a safety checklist will be performed by&#xD;
        the block room team before performing the block. Standard Canadian Anesthesia Society&#xD;
        monitoring will be provided. After surgery, the patient will be taken to the Post Anesthesia&#xD;
        Care Unit. At this moment, an Arrow® (StimuCath® Continuous Peripheral Nerve Block Catheter)&#xD;
        continuous adductor canal block catheter will be inserted using a Sonosite Edge II ultrasound&#xD;
        machine. The patient may be discharged home after achieving the discharge criteria, keeping&#xD;
        the peripheral nerve catheter with the same infusion rate for the planned time. The adductor&#xD;
        canal catheter will infuse for 48 hours. Prior to going home, patients will receive education&#xD;
        and written information (educational pamphlet) regarding monitoring for local anesthetic&#xD;
        systemic toxicity symptoms, possible CABC associated complications including potential&#xD;
        transient muscle weakness, and instructions on patient removal of the catheter after 48&#xD;
        hours. The study coordinator will collect the data once a day at 24, 48, 72 hrs, seven, 30&#xD;
        and 90 days postoperatively. Data collection will require at maximum 15 minutes.&#xD;
  &#xD;
        Sample Size Sample size justification was based on the primary outcome, and the primary&#xD;
        objective. The sample size was calculated based on previous study (12) that showed a 48-hour&#xD;
        opioid consumption of 30mg (+/- 15 mg) morphine equivalents in knee replacement surgeries at&#xD;
        our institute. Investigators anticipate a 50% decrease of opioid use in the intervention&#xD;
        group with an alpha of 0.05, power of 80%, and an enrolment ratio of 1:1 (between the 2&#xD;
        groups). This will require 16 subjects in each group for a total of 32 patients. To&#xD;
        compensate for 15 to 20% anticipated dropouts from the study, investigators plan for an&#xD;
        inclusion of 40 patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 3, 2024</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>opioid consumption</measure>
      <time_frame>At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively</time_frame>
      <description>opioid consumption. Total opioid consumption changes will be assessed at 24, 48, 72 hours, seven, 30 and 90 days postoperatively.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quality of Recovery</measure>
      <time_frame>At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively</time_frame>
      <description>Quality of Recovery (via QoR-15) total score. Changes will be assessed via QoR-15 (Quality of Recovery). (From score 0 to 10, higher scores mean a better outcome .(At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intensity of postoperative pain</measure>
      <time_frame>At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively</time_frame>
      <description>The intensity of postoperative pain. Changes will be assessed by Visual Analog Scale (VAS) at rest and movement once a day using a categorical pain scoring system. (From score 0 to 10, higher scores mean a worse outcome) (At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Opioid related side effects</measure>
      <time_frame>At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively</time_frame>
      <description>Opioid related side effects. Changes will be assessed using Opioid-related symptom Distress Scale (ORSDS). (At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Total Knee Arthroplasty</condition>
    <arm_group>
      <arm_group_label>CACB</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>continuous adductor canal block</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>sham continuous adductor canal block - ShACB</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>continuous adductor canal block (CACB) ropivacaine</intervention_name>
      <description>The CACB group will receive an infusion of 0.2% ropivacaine 5mL/h</description>
      <arm_group_label>CACB</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>sham continuous adductor canal block - ShACB NaCl</intervention_name>
      <description>sham continuous adductor canal block - ShACB and ShACB group will receive an infusion of NaCl 0.9% 5mL/h.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing unilateral primary TKA in the fast track setting.&#xD;
  &#xD;
            -  Patients older than 21 years of age, with American Society of Anesthesiologists (ASA)&#xD;
  &#xD;
            -  Physical status I-III&#xD;
  &#xD;
            -  No alcohol or drug dependency&#xD;
  &#xD;
            -  Sufficient understand and co-operation about the perineural catheter.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Perioperative complication or discharge delay leading to hospital admission.&#xD;
  &#xD;
            -  Chronic opioid use of morphine 30mg equivalent per day for last 2 consecutive weeks.&#xD;
  &#xD;
            -  Allergy to the study medications;&#xD;
  &#xD;
            -  Coagulopathy and platelet count &lt; 105/μL;&#xD;
  &#xD;
            -  Patients with contraindications to the insertion of an epidural or adductor canal&#xD;
               catheter (severe anatomic abnormalities or history of previous surgery at the site of&#xD;
               catheter placement).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Naveed Siddiqui, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Associate Professor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Naveed Siddiqui, MD</last_name>
      <phone>416-586-4800</phone>
      <phone_ext>5270</phone_ext>
      <email>naveed.siddiqui@uhn.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yehoshua Gleicher, MD</last_name>
      <phone>416-586-4800</phone>
      <phone_ext>5270</phone_ext>
      <email>Josh.Gleicher@sinaihealth.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mount Sinai Hospital, Toronto</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M5G 1X5</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Naveed Siddiqui, MD</last_name>
        <phone>416 586 4800</phone>
        <phone_ext>5270</phone_ext>
        <email>naveed.siddiqui@uhn.on.ca</email>
      </contact>
      <investigator>
        <last_name>Naveed Siddiqui, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yehoshua Gleicher, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sharon Peacock, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jesse Wolfstadt, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>David Backstein, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Hermann dos Santos Fernandes, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <citation>Price AJ, Alvand A, Troelsen A, Katz JN, Hooper G, Gray A, Carr A, Beard D. Knee replacement. Lancet. 2018 Nov 3;392(10158):1672-1682. doi: 10.1016/S0140-6736(18)32344-4.</citation>
      <PMID>30496082</PMID>
    </reference>
    <reference>
      <citation>Cullom C, Weed JT. Anesthetic and Analgesic Management for Outpatient Knee Arthroplasty. Curr Pain Headache Rep. 2017 May;21(5):23. doi: 10.1007/s11916-017-0623-y.</citation>
      <PMID>28283810</PMID>
    </reference>
    <reference>
      <citation>Wang J, Vahid S, Eberg M, Milroy S, Milkovich J, Wright FC, Hunter A, Kalladeen R, Zanchetta C, Wijeysundera HC, Irish J. Clearing the surgical backlog caused by COVID-19 in Ontario: a time series modelling study. CMAJ. 2020 Nov 2;192(44):E1347-E1356. doi: 10.1503/cmaj.201521. Epub 2020 Sep 1.</citation>
      <PMID>32873541</PMID>
    </reference>
    <reference>
      <citation>Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.</citation>
      <PMID>20889937</PMID>
    </reference>
    <reference>
      <citation>Sharma S, Iorio R, Specht LM, Davies-Lepie S, Healy WL. Complications of femoral nerve block for total knee arthroplasty. Clin Orthop Relat Res. 2010 Jan;468(1):135-40. doi: 10.1007/s11999-009-1025-1. Epub 2009 Aug 13.</citation>
      <PMID>19680735</PMID>
    </reference>
    <reference>
      <citation>Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.</citation>
      <PMID>29721648</PMID>
    </reference>
    <reference>
      <citation>Leung P, Dickerson DM, Denduluri SK, Mohammed MK, Lu M, Anitescu M, Luu HH. Postoperative continuous adductor canal block for total knee arthroplasty improves pain and functional recovery: A randomized controlled clinical trial. J Clin Anesth. 2018 Sep;49:46-52. doi: 10.1016/j.jclinane.2018.06.004. Epub 2018 Jun 8.</citation>
      <PMID>29890381</PMID>
    </reference>
    <reference>
      <citation>Yu R, Wang H, Zhuo Y, Liu D, Wu C, Zhang Y. Continuous adductor canal block provides better performance after total knee arthroplasty compared with the single-shot adductor canal block?: An updated meta-analysis of randomized controlled trials. Medicine (Baltimore). 2020 Oct 23;99(43):e22762. doi: 10.1097/MD.0000000000022762.</citation>
      <PMID>33120783</PMID>
    </reference>
    <reference>
      <citation>Hanson NA, Lee PH, Yuan SC, Choi DS, Allen CJ, Auyong DB. Continuous ambulatory adductor canal catheters for patients undergoing knee arthroplasty surgery. J Clin Anesth. 2016 Dec;35:190-194. doi: 10.1016/j.jclinane.2016.07.022. Epub 2016 Aug 30.</citation>
      <PMID>27871518</PMID>
    </reference>
    <reference>
      <citation>Myles PS. More than just morbidity and mortality - quality of recovery and long-term functional recovery after surgery. Anaesthesia. 2020 Jan;75 Suppl 1:e143-e150. doi: 10.1111/anae.14786.</citation>
      <PMID>31903564</PMID>
    </reference>
    <reference>
      <citation>Sun C, Zhang X, Song F, Zhao Z, Du R, Wu S, Ma Q, Cai X. Is continuous catheter adductor canal block better than single-shot canal adductor canal block in primary total knee arthroplasty?: A GRADE analysis of the evidence through a systematic review and meta-analysis. Medicine (Baltimore). 2020 May;99(20):e20320. doi: 10.1097/MD.0000000000020320.</citation>
      <PMID>32443383</PMID>
    </reference>
    <reference>
      <citation>Khan MI, Khandadashpoor S, Rai Y, Vertolli G, Backstein D, Siddiqui N. Comparing Analgesia on an As-Needed Basis to Traditional Intravenous Patient-Controlled Analgesia Within Fast-Track Orthopedic Procedures: A Randomized Controlled Trial. Pain Manag Nurs. 2022 Dec;23(6):832-837. doi: 10.1016/j.pmn.2022.04.003. Epub 2022 May 20.</citation>
      <PMID>35599141</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 8, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</investigator_affiliation>
      <investigator_full_name>Dr. Naveed Siddiqui</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Orthopaedic</keyword>
    <keyword>Postoperative Pain Management</keyword>
    <keyword>total knee arthroplasty</keyword>
    <keyword>Continuous adductor canal block</keyword>
    <keyword>Fast-track</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ropivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962970
  org study id: 21-0041-A
  nct id: NCT05962970
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Total knee arthroplasty (TKA) is a frequent performed surgery. Many institutions are
        implementing fast track programs for this surgery and adequate pain management is an
        important feature. Analgesic duration of single shot nerve blocks is limited to no more than
        24h. Conversely, the use of continuous nerve block (CNB) through a perineural catheter and
        infusion of local anesthetic may increase duration of analgesia and provide better outcomes.
        The purpose of this study is to evaluate effectiveness and safety of using CNB in patients
        undergoing ambulatory TKA, and its effects on patients' quality of recovery. Investigators
        hypothesize that continuous adductor canal block would lead to decrease in opioid consumption
        in patients undergoing fast track TKA.
  
        Significance There are no published prospective randomized controlled trials to assess
        patient's reported quality of recovery after receiving CACB in same day primary knee
        arthroplasties. As this is a frequent type of surgery and has the prediction to increase its
        incidence for the next years, there is significant importance in investigations about
        interventions which may improve its recovery in a fast track regime. A postoperative
        analgesic technique that offers better pain control, has less adverse effects, reduces the
        opioid analgesia requirement and is safe to be used in a fast track setting may have
        additional impact on decreasing health care cost and may lead to an enhanced recovery and
        better quality of life.
  
        Objectives To evaluate effectiveness and safety of using CACB in patients undergoing
        ambulatory TKA, in comparison to SACB. Primary objective is opioid consumption (in oral
        morphine equivalent doses) Secondary objectives are to evaluate postoperative QoR-15 scores
        (10), pain scores, opioid-induced adverse effects (measured via validated opioid symptom
        distress scale), postoperative functional status, complications relating to the perineural
        catheter and readmissions.
  Objectives The aim of this study is to examine the effect of CACB on decreasing opioid
        consumption, increasing the Quality of Recovery (measured via QoR-15) total score and
        decreasing opioid-related side effects. Investigators will also assess the rate of
        readmissions in primary knee arthroplasty patients.
  
        Rationale
  
        Pain management in knee arthroplasty patients poses unique challenges for the
        anesthesiologist, especially in the immediate post-operative period. Early postoperative
        analgesia is limited to a unimodality of intravenous opioids. Recently, adductor canal blocks
        have started to replace femoral blocks, as this technique can provide similar analgesic
        results while avoiding the quadriceps muscle weakness associated with femoral nerve blocks.
        The use of a continuous adductor canal catheter in the post-discharge phase shows promising
        as the next step in knee arthroplasty pain management allowing for shorter lengths of stay or
        even same day discharge (3).
  
        Significance and Innovation
  
        Total knee arthroplasty (TKA) is the second most common inpatient surgery in the U.S. and
        Canada, and is associated with severe postoperative pain, limiting early ambulation and
        optimal functional recovery. Perioperative opioid use has been linked with many adverse
        outcomes including opioid dependence. This study aims to demonstrate the utility of CACB as
        an adjunct strategy to reduce opioid consumption and improve quality of recovery in primary
        knee arthroplasty patients. The innovation in this approach lies not only in less opioid
        consumption and opioid induced side effects but also in reducing the burden of postoperative
        pain, leading to an enhanced recovery and better quality of life. Establishing the safeness
        of this method in an outpatient setting may have the additional impact of decreasing health
        care costs and may lead to reduce opioid prescriptions on discharge from the hospital.
  
        This will be the first study assessing patient's reported quality of recovery after receiving
        CACB for primary knee arthroplasties. Investigators expect that that the use of CACB will
        improve patients' quality of recovery, alleviate pain and also reduce opioid consumption and
        side effects.
  
        Methodology
  
        This will be a prospective, randomized double blind placebo controlled clinical trial. There
        will be two arms of treatment: intervention and control group. Preoperatively patients will
        be allocated at random to receive either Continuous adductor canal block (CACB) (intervention
        group) or sham continuous adductor canal block (ShACB) (control group).
  
        Work Plan
  
        This prospective trial would include unilateral primary TKA done under Fastrack protocol. The
        subjects will have their surgeries booked in advance and they will be submitted to the pre
        anesthesia consult at the Pre-Admission Unit a few days before the surgery. The study
        proposal will be explained to the patients at time of preadmission consult. They will receive
        a booklet with information about the study and the Consent Form that they will bring home
        with them. Patients will be randomized to one of the two groups using a computer-generated
        random numbers table. The elastomeric pumps to be used connected to the catheter will be
        previously prepared by hospital pharmacy, accordingly to the randomization made and the
        subject study number, with no identification of the content (NaCl 0.9% or Ropivacaine 0.2%).
        All patients will receive the same perioperative management. The only difference will be the
        postoperative continuous perineural infusion: the CACB group will receive an infusion of 0.2%
        ropivacaine 5mL/h and ShACB group will receive an infusion of NaCl 0.9% 5mL/h. Patients will
        initially be brought to a dedicated block room where a safety checklist will be performed by
        the block room team before performing the block. Standard Canadian Anesthesia Society
        monitoring will be provided. After surgery, the patient will be taken to the Post Anesthesia
        Care Unit. At this moment, an Arrow® (StimuCath® Continuous Peripheral Nerve Block Catheter)
        continuous adductor canal block catheter will be inserted using a Sonosite Edge II ultrasound
        machine. The patient may be discharged home after achieving the discharge criteria, keeping
        the peripheral nerve catheter with the same infusion rate for the planned time. The adductor
        canal catheter will infuse for 48 hours. Prior to going home, patients will receive education
        and written information (educational pamphlet) regarding monitoring for local anesthetic
        systemic toxicity symptoms, possible CABC associated complications including potential
        transient muscle weakness, and instructions on patient removal of the catheter after 48
        hours. The study coordinator will collect the data once a day at 24, 48, 72 hrs, seven, 30
        and 90 days postoperatively. Data collection will require at maximum 15 minutes.
  
        Sample Size Sample size justification was based on the primary outcome, and the primary
        objective. The sample size was calculated based on previous study (12) that showed a 48-hour
        opioid consumption of 30mg (+/- 15 mg) morphine equivalents in knee replacement surgeries at
        our institute. Investigators anticipate a 50% decrease of opioid use in the intervention
        group with an alpha of 0.05, power of 80%, and an enrolment ratio of 1:1 (between the 2
        groups). This will require 16 subjects in each group for a total of 32 patients. To
        compensate for 15 to 20% anticipated dropouts from the study, investigators plan for an
        inclusion of 40 patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: opioid consumption
  time frame: At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively
  description: opioid consumption. Total opioid consumption changes will be assessed at 24, 48, 72 hours, seven, 30 and 90 days postoperatively.
  measure: Quality of Recovery
  time frame: At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively
  description: Quality of Recovery (via QoR-15) total score. Changes will be assessed via QoR-15 (Quality of Recovery). (From score 0 to 10, higher scores mean a better outcome .(At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively)
  measure: Intensity of postoperative pain
  time frame: At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively
  description: The intensity of postoperative pain. Changes will be assessed by Visual Analog Scale (VAS) at rest and movement once a day using a categorical pain scoring system. (From score 0 to 10, higher scores mean a worse outcome) (At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively)
  measure: Opioid related side effects
  time frame: At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively
  description: Opioid related side effects. Changes will be assessed using Opioid-related symptom Distress Scale (ORSDS). (At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively)
  arm group label: CACB
  arm group type: Active Comparator
  description: continuous adductor canal block
  arm group label: Control group
  arm group type: Placebo Comparator
  description: sham continuous adductor canal block - ShACB
  intervention type: Drug
  intervention name: continuous adductor canal block (CACB) ropivacaine
  description: The CACB group will receive an infusion of 0.2% ropivacaine 5mL/h
  arm group label: CACB
  intervention type: Drug
  intervention name: sham continuous adductor canal block - ShACB NaCl
  description: sham continuous adductor canal block - ShACB and ShACB group will receive an infusion of NaCl 0.9% 5mL/h.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Naveed Siddiqui, MD
  role: Principal Investigator
  affiliation: Associate Professor
  last name: Naveed Siddiqui, MD
  phone: 416-586-4800
  phone ext: 5270
  email: naveed.siddiqui@uhn.ca
  last name: Yehoshua Gleicher, MD
  phone: 416-586-4800
  phone ext: 5270
  email: Josh.Gleicher@sinaihealth.ca
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Canada
  citation: Price AJ, Alvand A, Troelsen A, Katz JN, Hooper G, Gray A, Carr A, Beard D. Knee replacement. Lancet. 2018 Nov 3;392(10158):1672-1682. doi: 10.1016/S0140-6736(18)32344-4.
  PMID: 30496082
  citation: Cullom C, Weed JT. Anesthetic and Analgesic Management for Outpatient Knee Arthroplasty. Curr Pain Headache Rep. 2017 May;21(5):23. doi: 10.1007/s11916-017-0623-y.
  PMID: 28283810
  citation: Wang J, Vahid S, Eberg M, Milroy S, Milkovich J, Wright FC, Hunter A, Kalladeen R, Zanchetta C, Wijeysundera HC, Irish J. Clearing the surgical backlog caused by COVID-19 in Ontario: a time series modelling study. CMAJ. 2020 Nov 2;192(44):E1347-E1356. doi: 10.1503/cmaj.201521. Epub 2020 Sep 1.
  PMID: 32873541
  citation: Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.
  PMID: 20889937
  citation: Sharma S, Iorio R, Specht LM, Davies-Lepie S, Healy WL. Complications of femoral nerve block for total knee arthroplasty. Clin Orthop Relat Res. 2010 Jan;468(1):135-40. doi: 10.1007/s11999-009-1025-1. Epub 2009 Aug 13.
  PMID: 19680735
  citation: Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.
  PMID: 29721648
  citation: Leung P, Dickerson DM, Denduluri SK, Mohammed MK, Lu M, Anitescu M, Luu HH. Postoperative continuous adductor canal block for total knee arthroplasty improves pain and functional recovery: A randomized controlled clinical trial. J Clin Anesth. 2018 Sep;49:46-52. doi: 10.1016/j.jclinane.2018.06.004. Epub 2018 Jun 8.
  PMID: 29890381
  citation: Yu R, Wang H, Zhuo Y, Liu D, Wu C, Zhang Y. Continuous adductor canal block provides better performance after total knee arthroplasty compared with the single-shot adductor canal block?: An updated meta-analysis of randomized controlled trials. Medicine (Baltimore). 2020 Oct 23;99(43):e22762. doi: 10.1097/MD.0000000000022762.
  PMID: 33120783
  citation: Hanson NA, Lee PH, Yuan SC, Choi DS, Allen CJ, Auyong DB. Continuous ambulatory adductor canal catheters for patients undergoing knee arthroplasty surgery. J Clin Anesth. 2016 Dec;35:190-194. doi: 10.1016/j.jclinane.2016.07.022. Epub 2016 Aug 30.
  PMID: 27871518
  citation: Myles PS. More than just morbidity and mortality - quality of recovery and long-term functional recovery after surgery. Anaesthesia. 2020 Jan;75 Suppl 1:e143-e150. doi: 10.1111/anae.14786.
  PMID: 31903564
  citation: Sun C, Zhang X, Song F, Zhao Z, Du R, Wu S, Ma Q, Cai X. Is continuous catheter adductor canal block better than single-shot canal adductor canal block in primary total knee arthroplasty?: A GRADE analysis of the evidence through a systematic review and meta-analysis. Medicine (Baltimore). 2020 May;99(20):e20320. doi: 10.1097/MD.0000000000020320.
  PMID: 32443383
  citation: Khan MI, Khandadashpoor S, Rai Y, Vertolli G, Backstein D, Siddiqui N. Comparing Analgesia on an As-Needed Basis to Traditional Intravenous Patient-Controlled Analgesia Within Fast-Track Orthopedic Procedures: A Randomized Controlled Trial. Pain Manag Nurs. 2022 Dec;23(6):832-837. doi: 10.1016/j.pmn.2022.04.003. Epub 2022 May 20.
  PMID: 35599141
  responsible party type: Principal Investigator
  investigator affiliation: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
  investigator full name: Dr. Naveed Siddiqui
  investigator title: Principal Investigator
  mesh term: Ropivacaine
  sharing ipd: No