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/NCT05981105</url>
    </required_header>
    <id_info>
      <org_study_id>2017-1858 pt 2</org_study_id>
      <nct_id>NCT05981105</nct_id>
    </id_info>
    <brief_title>Enhanced Recovery After Major Surgery and Chronic Pain for Total Knee Arthroplasty</brief_title>
    <official_title>Expanding the Peri-operative Surgical Home Model: ERAS TKR With a Transitional Pain Service (TeleTPS) - Continuous Adductor Canal Catheter Versus Adductor Canal Block for Total Knee Arthroplasty, a Randomized Double-blinded Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital for Special Surgery, New York</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospital for Special Surgery, New York</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this interventional clinical trial is to assess opioid consumption 24-48 hrs post&#xD;
        anesthesia block among patients undergoing total knee arthroplasty. The main question it aims&#xD;
        to answer is:&#xD;
  &#xD;
        1. Is there a difference in opioid consumption 24-48 hours post block administration among&#xD;
        patients that receive an adductor canal catheter (ACC) versus adductor canal block (ACB)?&#xD;
  &#xD;
        Participants will be:&#xD;
  &#xD;
          -  Randomized to receive an adductor canal catheter (ACC) or a sham adductor canal&#xD;
             catheter.&#xD;
  &#xD;
          -  Asked to use the Diagnotes application to communicate with the pain doctor while the&#xD;
             catheter is in place.&#xD;
  &#xD;
          -  Follow up for up to 6 months post-operation. Researchers will compare the interventional&#xD;
             group (ACC) to the control group (sham ACC + ACB) to see if there is difference in&#xD;
             opioid consumption and chronic pain at 6 months post-operation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to see if adding a continuous ACB catheter will extend analgesia&#xD;
        beyond the 24-48 hour period. This interventional clinical trial will assess opioid&#xD;
        consumption in patients undergoing total knee arthroplasty 24 to 48 hours after anesthesia&#xD;
        block. Rebound pain is a well-known phenomenon in which patients experience severe pain&#xD;
        immediately after the nerve block is removed. It is also known that by extending the duration&#xD;
        of analgesia, you can reduce or prevent rebound pain. Motor sparing compartment blocks have&#xD;
        transformed patients' ability to participate in rehabilitation earlier than ever before, even&#xD;
        ambulating on POD 0. Thus, by extending analgesia and encouraging early ambulation, adductor&#xD;
        canal catheters are likely to not only reduce opioid consumption but also allow for earlier&#xD;
        discharge. The two &quot;hot&quot; themes in recent total knee replacement analgesia pathways are not&#xD;
        only providing an effective Enhanced recovery after surgery (ERAD) protocol, but also&#xD;
        combating the opioid epidemic through regional anesthesia and non-opioid multimodal pathways.&#xD;
        This study will assist in determining which modality is superior (single shot blocks with&#xD;
        additive versus catheter) and will introduce a novel method of following patients at home via&#xD;
        a transitional pain service (telemedicine). This research will further investigate chronic&#xD;
        pain 6 months after surgery.&#xD;
  &#xD;
        Patients in the intervention group will have a catheter that continuously infuses numbing&#xD;
        medication into their operative leg for 50 hours (up to POD 3). It is hypothesized that the&#xD;
        patient will have better pain control, mobility, and less rebound pain, which is common&#xD;
        following POD 1. By infusing the catheter with a disposable single use ambIT system (Summit&#xD;
        Medical Products), all patients enrolled in the intervention group (ACC) will have the same&#xD;
        amount running continuously, allowing the patient to be discharged with the catheter in place&#xD;
        before the 50-hour infusion is completed. Prior to discharge, patients will be instructed on&#xD;
        how to remove the catheter and will be able to download the Smartphone app &quot;Diagnotes&quot; at the&#xD;
        hospital. While the catheter is in place, the Diagnotes app (a HIPPA-compliant text messaging&#xD;
        service) will be the patient's primary means of communication with the pain doctor at home.&#xD;
  &#xD;
        Patients in the control group will have a sham (fake) catheter attached to their operative&#xD;
        leg for 50 hours. Patients will also be instructed on how to remove the catheter prior to&#xD;
        discharge and will be able to download the Smartphone app &quot;Diagnotes&quot; in the hospital. While&#xD;
        the catheter is in place, the Diagnotes app (a HIPPA-compliant text messaging service) will&#xD;
        be the patient's primary means of communication with the pain doctor at home.&#xD;
  &#xD;
        Researchers will contact both groups for follow-ups for up to 6 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 12, 2023</start_date>
    <completion_date type="Anticipated">June 12, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 12, 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>
      <intervention_model_description>Double-blinded randomized control trial</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Participants will be randomized to the intervention group (adductor canal catheter, ACC) or control group (sham adductor canal catheterm, ACB). The research staff and participants will be blinded as to which group the participant is in. The primary investigator and co-investigators will not be blinded. The research staff will provide PI and Co-I with an envelope that informs them which group the participant is randomized to so the proper research activities are carried out.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Opioid consumption at 24-48 hours</measure>
      <time_frame>from 24 hours to 48 hours</time_frame>
      <description>The cumulative opioid consumption 24-48 hours post block administration. Measured in morphine milligram equivalents per day.&#xD;
  Although collected over a period of time, the total amount will be summed and the average will be reported.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Opioid consumption at 72 hours, 96 hours, and 1 week</measure>
      <time_frame>72 hours to 1 week</time_frame>
      <description>The cumulative opioid consumption 72hours, 96 hours, and 1 week post block administration. Measured in morphine milligram equivalents per day.&#xD;
  Although collected over a period of time, the total amount will be summed and the average will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Numerical Pain Rating Score</measure>
      <time_frame>Day of surgery to post operative day (POD) 60</time_frame>
      <description>Patients are asked to give a number between 0 and 10 that best fits their pain intensity. The scale is 0 = 'no pain at all' whereas 10 = 'the worst pain ever possible'.&#xD;
  Measured at multiple time points: DOS, post-operative day (POD) 1, POD 2, POD 3, POD 4, POD 7, &amp; POD 60</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Therapy Milestones</measure>
      <time_frame>post operative day (POD) 1 up to POD 4</time_frame>
      <description>Collected from the physical therapy notes. This outcome will assess for time to ambulation (measured in distance traveled, stairs, time of ambulating &gt; 30 meters, and reaching discharge criteria).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Satisfaction with Pain Control</measure>
      <time_frame>post operative day (POD) 1, 2, 4 &amp; 60</time_frame>
      <description>Patients are asked to report on their satisfaction with pain control on a scale of 0 to 10, with 0 = extremely dissatisfied and 10 = extremely satisfied.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital Length of Stay</measure>
      <time_frame>up to 7 days after the day of surgery</time_frame>
      <description>From when the patient is in the PACU to when the patient has been discharged from the hospital. PACU time = &quot;PACU Transfer In&quot; and Discharge time = &quot;Discharge&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Opioid Related Symptom Distress Scale (ORSDS)</measure>
      <time_frame>after the surgery end time, on post operative day (POD) 1, 4, and 60</time_frame>
      <description>The Opioid-Related Symptom Distress Scale (ORSDS) is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who experienced Buckling/Falls/Quadricep during physical therapy</measure>
      <time_frame>On post operative day (POD) 1, 2, 3, 4</time_frame>
      <description>Whether a participant experiences buckling, falls, or quadricep weakness during physical therapy, precluding ambulation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidents of participants experiencing a blood loss during surgical procedure</measure>
      <time_frame>During surgery</time_frame>
      <description>Whether the participant experienced any blood loss during their surgical procedure.&#xD;
  Measured in binary responses (yes/no).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Block resolution</measure>
      <time_frame>Up to post operative day 3</time_frame>
      <description>The patient will be asked in the morning of POD 1 when they feel the block has worn off, and in the evening of POD 3 after the catheter has been removed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distance of ambulation</measure>
      <time_frame>post operative day (POD) 0,1,2,3,4</time_frame>
      <description>The total distance of ambulation during physical therapy while the patient is inpatient, collected from the physical therapy notes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Catheter related complications</measure>
      <time_frame>up to post operative day 4</time_frame>
      <description>Patient will be asked if they have experience any of the following with regards to the catheter:&#xD;
  delayed weakness, unintentional dislodgment, leakage, catheter infection, dysesthesias, falls, LAST</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidences of participants readmitted for pain control</measure>
      <time_frame>3 month after surgery</time_frame>
      <description>Whether the patient was readmitted to a hospital for additional pain control.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Block complications</measure>
      <time_frame>up to post operative day 4</time_frame>
      <description>Patients will report if they experience any block complications including, neuropraxia (saphenous), transient palsies: peroneal, tibial nerve.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)</measure>
      <time_frame>before surgery and up to post operative day 60</time_frame>
      <description>The survey asks for patients' view about their knee, such as how they feel about their knee and how well they are able to do usual activities. Choices on each question are: none, mild, moderate, severe, extreme</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Orthopedic Outcome Flexion/Knee Society Score</measure>
      <time_frame>6 weeks</time_frame>
      <description>Patient will be asked about their range of motion (flexion ROM and Extension ROM). Data collected from surgeon's note</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SF-36 questionnaire</measure>
      <time_frame>up to post operative day 60</time_frame>
      <description>The SF-36 measures includes the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH).&#xD;
  Measured on a scale of 1 to 3, with 1 = &quot;yes limited a lot&quot;, 2 = &quot;yes limited a little&quot;, 3 = &quot;no not limited at all&quot;.&#xD;
  The total score for each participant is calculated and then all the scores are average across all participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)</measure>
      <time_frame>at 3 months &amp; 6 months</time_frame>
      <description>The Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS) comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.&#xD;
  Out of the seven items in the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS), five are symptom related and two are examination items.&#xD;
  If patient reports surgery-related pain greater than 3 on the NRS at the 3 months and 6 months postoperative visit, patient will complete this questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Current opioid misuse measure (COMM)</measure>
      <time_frame>at 3 months &amp; 6 months</time_frame>
      <description>The Current Opioid Misuse Measure (COMM) is a commonly used self-report instrument to identify and monitor aberrant opioid-related behavior in chronic pain patients on opioid therapy.&#xD;
  At the 3 months and 6 months postoperative visit, if patients are still being prescribed opioids, patient will be asked to fill out the questionnaire&#xD;
  Choices on the questionnaire are:&#xD;
  never, seldom, sometimes, often, very often</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of patient contact via text messaging/video calls</measure>
      <time_frame>up to post operative day 4</time_frame>
      <description>Research staff will mark if patients contacted the pain doctor via the Diagnotes application.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of unused opioids</measure>
      <time_frame>up to post operative day 7</time_frame>
      <description>Patients will be asked at 1 week post-operation, about their pain medication usage (how many pills of your opioid medication do you have left?)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain catastrophizing scale (PCS)</measure>
      <time_frame>before the surgery and up to post operative day 60</time_frame>
      <description>The Pain Catastrophizing Scale (PCS) assesses the extent of catastrophic thinking due to low back pain according to 3 components: rumination, magnification, and helplessness. It is a 13-item scale, with a total range of 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain Disability Index (PDI)</measure>
      <time_frame>3 months &amp; 6 months</time_frame>
      <description>The Pain Disability Index (PDI) is a widely-used instrument to measure pain-related disability.&#xD;
  Scoring: Scores are assigned based on an 11-point scale ranging from 0 (no disability) to 10 (total disability). Scores range from 0 to 70. The higher the index the greater the person's disability due to pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blinding Assessment</measure>
      <time_frame>up to post operative day 2</time_frame>
      <description>Patient and research staff will report which group they believe the patient was randomized to.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidents of participants experiencing block complications</measure>
      <time_frame>up to post operative day 4</time_frame>
      <description>Data on whether patient experienced quadriceps weakness and foot drop during physical therapy. Collected from physical therapy notes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non Opioid Pain medications consumption</measure>
      <time_frame>up to post operative day 60</time_frame>
      <description>Research staff will document any non-opioid pain medications (lyrica, robaxin, tyelnol, etc) taken by each participant. Medications may be given at the discretion of the APS service.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intravenous patient control analgesia (IV PCA) usage</measure>
      <time_frame>up to post operative day 7</time_frame>
      <description>Research staff will document if patient received IV PCA during their stay at the hospital. Measured in morphine equivalent.&#xD;
  Discharge times can vary from participant to participant (from POD 0 up until POD 2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of induction</measure>
      <time_frame>During the surgical procedure</time_frame>
      <description>The time it takes for the patient to be induced. Measured from induction start to induction end.&#xD;
  Times for each participants will be calculated (in minutes) and then average across all participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of tourniquet use</measure>
      <time_frame>During the surgical procedure</time_frame>
      <description>The total time to use a tourniquet. Measured from tourniquet inflated time tourniquet deflated time.&#xD;
  Times for each participants will be calculated (in minutes) and then average across all participants.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">64</enrollment>
    <condition>Chronic Pain</condition>
    <condition>Opioid Use</condition>
    <condition>Adductor Canal Block</condition>
    <condition>Total Knee Arthroplasty</condition>
    <arm_group>
      <arm_group_label>Adductor Canal Catheter (ACC) - Interventional</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will received the an adductor canal catheter that continuously infuses numbing medication to their operative leg for 50 hours post-surgery.&#xD;
  Patients will also communicate with their pain doctor via the Diagnotes application while the catheter is in place.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Adductor Canal Block (ACB) - Control</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Patients will received the a sham adductor canal catheter that is attached to their operative leg for 50 hours post-surgery.&#xD;
  Patients will also communicate with their pain doctor via the Diagnotes application while the catheter is in place.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ambIT pump with catheter</intervention_name>
      <description>0.2% ropivacaine will be infused through a catheter pump at a rate of 10 ml/hr, 600 ml reservoir.</description>
      <arm_group_label>Adductor Canal Catheter (ACC) - Interventional</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ambIT pump with sham catheter</intervention_name>
      <description>sham catheter with no infusion</description>
      <arm_group_label>Adductor Canal Block (ACB) - Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with osteoarthritis scheduled for a primary total knee arthroplasty with a&#xD;
               participating surgeon&#xD;
  &#xD;
            -  Age 18 to 75 years&#xD;
  &#xD;
            -  Planned use of regional anesthesia&#xD;
  &#xD;
            -  Ability to follow study protocol&#xD;
  &#xD;
            -  English speaking (secondary outcomes include questionnaires validated in English only)&#xD;
  &#xD;
            -  Patients of participating surgeons: Drs. Mayman, Jerabek, Westrich, Su, Della Valle,&#xD;
               Alexiades&#xD;
  &#xD;
            -  Lives within one hour of the hospital&#xD;
  &#xD;
            -  Has a smartphone&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Hepatic or renal insufficiency&#xD;
  &#xD;
            -  Younger than 18 years old and older than 65&#xD;
  &#xD;
            -  Patients undergoing general anesthesia&#xD;
  &#xD;
            -  Allergy or intolerance to one of the study medications&#xD;
  &#xD;
            -  BMI &gt; 40&#xD;
  &#xD;
            -  Diabetes&#xD;
  &#xD;
            -  ASA of III,IV&#xD;
  &#xD;
            -  Chronic gabapentin/pregabalin use (regular use for longer than 3 months)&#xD;
  &#xD;
            -  PCS &gt; 30&#xD;
  &#xD;
            -  Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine&#xD;
               equivalent of &gt;5mg/day for one month)&#xD;
  &#xD;
            -  Patients with severe valgus deformity or flexion contracture&#xD;
  &#xD;
            -  Patients unable to follow home catheter instructions and unwilling to go home with an&#xD;
               infusing catheter&#xD;
  &#xD;
            -  Patients who have no home caregivers in the event if a catheter is to be sent home&#xD;
               with the patient&#xD;
  &#xD;
            -  Patients with planned stay at rehab facility&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stavros Memtsoudis, MD/PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital for Special Surgery, New York</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Justas Lauzadis, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Hospital for Special Surgery, New York</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Justas Lauzadis, PhD</last_name>
      <phone>212-774-2946</phone>
      <email>lauzadisj@hss.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Stavros Memtsoudis, MD/PhD</last_name>
      <phone>212-606-1036</phone>
      <email>memtsoudiss@hss.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital for Special Surgery</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10021</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Justas Lauzadis, PhD</last_name>
        <phone>212-774-2946</phone>
        <email>lauzadisj@hss.edu</email>
      </contact>
      <contact_backup>
        <last_name>Pa Thor, PhD</last_name>
        <phone>646-797-8535</phone>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <results_reference>
      <citation>Katz J, Weinrib A, Fashler SR, Katznelzon R, Shah BR, Ladak SS, Jiang J, Li Q, McMillan K, Santa Mina D, Wentlandt K, McRae K, Tamir D, Lyn S, de Perrot M, Rao V, Grant D, Roche-Nagle G, Cleary SP, Hofer SO, Gilbert R, Wijeysundera D, Ritvo P, Janmohamed T, O'Leary G, Clarke H. The Toronto General Hospital Transitional Pain Service: development and implementation of a multidisciplinary program to prevent chronic postsurgical pain. J Pain Res. 2015 Oct 12;8:695-702. doi: 10.2147/JPR.S91924. eCollection 2015.</citation>
      <PMID>26508886</PMID>
    </results_reference>
    <results_reference>
      <citation>Chen YK, Boden KA, Schreiber KL. The role of regional anaesthesia and multimodal analgesia in the prevention of chronic postoperative pain: a narrative review. Anaesthesia. 2021 Jan;76 Suppl 1(Suppl 1):8-17. doi: 10.1111/anae.15256.</citation>
      <PMID>33426669</PMID>
    </results_reference>
    <results_reference>
      <citation>Benthien JP, Huebner D. Efficacy of continuous catheter analgesia of the sciatic nerve after total knee arthroplasty. Swiss Med Wkly. 2015 Feb 19;145:w14119. doi: 10.4414/smw.2015.14119. eCollection 2015.</citation>
      <PMID>25695308</PMID>
    </results_reference>
    <results_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>
    </results_reference>
    <results_reference>
      <citation>Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.</citation>
      <PMID>15866968</PMID>
    </results_reference>
    <results_reference>
      <citation>Wainwright TW, Gill M, McDonald DA, Middleton RG, Reed M, Sahota O, Yates P, Ljungqvist O. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Feb;91(1):3-19. doi: 10.1080/17453674.2019.1683790. Epub 2019 Oct 30.</citation>
      <PMID>31663402</PMID>
    </results_reference>
    <results_reference>
      <citation>Kovalak E, Dogan AT, Uzumcugil O, Obut A, Yildiz AS, Kanay E, Tuzuner T, Ozyuvaci E. A comparison of continuous femoral nerve block and periarticular local infiltration analgesia in the management of early period pain developing after total knee arthroplasty. Acta Orthop Traumatol Turc. 2015;49(3):260-6. doi: 10.3944/AOTT.2015.14.0263.</citation>
      <PMID>26200404</PMID>
    </results_reference>
    <results_reference>
      <citation>Horn BJ, Cien A, Reeves NP, Pathak P, Taunt CJ Jr. Femoral Nerve Block vs Periarticular Bupivacaine Liposome Injection After Primary Total Knee Arthroplasty: Effect on Patient Outcomes. J Am Osteopath Assoc. 2015 Dec;115(12):714-9. doi: 10.7556/jaoa.2015.146.</citation>
      <PMID>26618816</PMID>
    </results_reference>
    <results_reference>
      <citation>Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.</citation>
      <PMID>24401769</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chronic Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No plan to share IPD with other researchers.</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>June 9, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT05981105/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05981105
  org study id: 2017-1858 pt 2
  nct id: NCT05981105
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The goal of this interventional clinical trial is to assess opioid consumption 24-48 hrs post
        anesthesia block among patients undergoing total knee arthroplasty. The main question it aims
        to answer is:
  
        1. Is there a difference in opioid consumption 24-48 hours post block administration among
        patients that receive an adductor canal catheter (ACC) versus adductor canal block (ACB)?
  
        Participants will be:
  
          -  Randomized to receive an adductor canal catheter (ACC) or a sham adductor canal
             catheter.
  
          -  Asked to use the Diagnotes application to communicate with the pain doctor while the
             catheter is in place.
  
          -  Follow up for up to 6 months post-operation. Researchers will compare the interventional
             group (ACC) to the control group (sham ACC + ACB) to see if there is difference in
             opioid consumption and chronic pain at 6 months post-operation.
  The purpose of this study is to see if adding a continuous ACB catheter will extend analgesia
        beyond the 24-48 hour period. This interventional clinical trial will assess opioid
        consumption in patients undergoing total knee arthroplasty 24 to 48 hours after anesthesia
        block. Rebound pain is a well-known phenomenon in which patients experience severe pain
        immediately after the nerve block is removed. It is also known that by extending the duration
        of analgesia, you can reduce or prevent rebound pain. Motor sparing compartment blocks have
        transformed patients' ability to participate in rehabilitation earlier than ever before, even
        ambulating on POD 0. Thus, by extending analgesia and encouraging early ambulation, adductor
        canal catheters are likely to not only reduce opioid consumption but also allow for earlier
        discharge. The two "hot" themes in recent total knee replacement analgesia pathways are not
        only providing an effective Enhanced recovery after surgery (ERAD) protocol, but also
        combating the opioid epidemic through regional anesthesia and non-opioid multimodal pathways.
        This study will assist in determining which modality is superior (single shot blocks with
        additive versus catheter) and will introduce a novel method of following patients at home via
        a transitional pain service (telemedicine). This research will further investigate chronic
        pain 6 months after surgery.
  
        Patients in the intervention group will have a catheter that continuously infuses numbing
        medication into their operative leg for 50 hours (up to POD 3). It is hypothesized that the
        patient will have better pain control, mobility, and less rebound pain, which is common
        following POD 1. By infusing the catheter with a disposable single use ambIT system (Summit
        Medical Products), all patients enrolled in the intervention group (ACC) will have the same
        amount running continuously, allowing the patient to be discharged with the catheter in place
        before the 50-hour infusion is completed. Prior to discharge, patients will be instructed on
        how to remove the catheter and will be able to download the Smartphone app "Diagnotes" at the
        hospital. While the catheter is in place, the Diagnotes app (a HIPPA-compliant text messaging
        service) will be the patient's primary means of communication with the pain doctor at home.
  
        Patients in the control group will have a sham (fake) catheter attached to their operative
        leg for 50 hours. Patients will also be instructed on how to remove the catheter prior to
        discharge and will be able to download the Smartphone app "Diagnotes" in the hospital. While
        the catheter is in place, the Diagnotes app (a HIPPA-compliant text messaging service) will
        be the patient's primary means of communication with the pain doctor at home.
  
        Researchers will contact both groups for follow-ups for up to 6 months.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Double-blinded randomized control trial
  primary purpose: Other
  masking: Double (Participant, Outcomes Assessor)
  masking description: Participants will be randomized to the intervention group (adductor canal catheter, ACC) or control group (sham adductor canal catheterm, ACB). The research staff and participants will be blinded as to which group the participant is in. The primary investigator and co-investigators will not be blinded. The research staff will provide PI and Co-I with an envelope that informs them which group the participant is randomized to so the proper research activities are carried out.
  measure: Opioid consumption at 24-48 hours
  time frame: from 24 hours to 48 hours
  description: The cumulative opioid consumption 24-48 hours post block administration. Measured in morphine milligram equivalents per day.
  Although collected over a period of time, the total amount will be summed and the average will be reported.
  measure: Opioid consumption at 72 hours, 96 hours, and 1 week
  time frame: 72 hours to 1 week
  description: The cumulative opioid consumption 72hours, 96 hours, and 1 week post block administration. Measured in morphine milligram equivalents per day.
  Although collected over a period of time, the total amount will be summed and the average will be reported.
  measure: Numerical Pain Rating Score
  time frame: Day of surgery to post operative day (POD) 60
  description: Patients are asked to give a number between 0 and 10 that best fits their pain intensity. The scale is 0 = 'no pain at all' whereas 10 = 'the worst pain ever possible'.
  Measured at multiple time points: DOS, post-operative day (POD) 1, POD 2, POD 3, POD 4, POD 7, & POD 60
  measure: Physical Therapy Milestones
  time frame: post operative day (POD) 1 up to POD 4
  description: Collected from the physical therapy notes. This outcome will assess for time to ambulation (measured in distance traveled, stairs, time of ambulating > 30 meters, and reaching discharge criteria).
  measure: Patient Satisfaction with Pain Control
  time frame: post operative day (POD) 1, 2, 4 & 60
  description: Patients are asked to report on their satisfaction with pain control on a scale of 0 to 10, with 0 = extremely dissatisfied and 10 = extremely satisfied.
  measure: Hospital Length of Stay
  time frame: up to 7 days after the day of surgery
  description: From when the patient is in the PACU to when the patient has been discharged from the hospital. PACU time = "PACU Transfer In" and Discharge time = "Discharge"
  measure: Opioid Related Symptom Distress Scale (ORSDS)
  time frame: after the surgery end time, on post operative day (POD) 1, 4, and 60
  description: The Opioid-Related Symptom Distress Scale (ORSDS) is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores.
  measure: Number of participants who experienced Buckling/Falls/Quadricep during physical therapy
  time frame: On post operative day (POD) 1, 2, 3, 4
  description: Whether a participant experiences buckling, falls, or quadricep weakness during physical therapy, precluding ambulation.
  measure: Incidents of participants experiencing a blood loss during surgical procedure
  time frame: During surgery
  description: Whether the participant experienced any blood loss during their surgical procedure.
  Measured in binary responses (yes/no).
  measure: Block resolution
  time frame: Up to post operative day 3
  description: The patient will be asked in the morning of POD 1 when they feel the block has worn off, and in the evening of POD 3 after the catheter has been removed.
  measure: Distance of ambulation
  time frame: post operative day (POD) 0,1,2,3,4
  description: The total distance of ambulation during physical therapy while the patient is inpatient, collected from the physical therapy notes.
  measure: Catheter related complications
  time frame: up to post operative day 4
  description: Patient will be asked if they have experience any of the following with regards to the catheter:
  delayed weakness, unintentional dislodgment, leakage, catheter infection, dysesthesias, falls, LAST
  measure: Incidences of participants readmitted for pain control
  time frame: 3 month after surgery
  description: Whether the patient was readmitted to a hospital for additional pain control.
  measure: Block complications
  time frame: up to post operative day 4
  description: Patients will report if they experience any block complications including, neuropraxia (saphenous), transient palsies: peroneal, tibial nerve.
  measure: Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)
  time frame: before surgery and up to post operative day 60
  description: The survey asks for patients' view about their knee, such as how they feel about their knee and how well they are able to do usual activities. Choices on each question are: none, mild, moderate, severe, extreme
  measure: Orthopedic Outcome Flexion/Knee Society Score
  time frame: 6 weeks
  description: Patient will be asked about their range of motion (flexion ROM and Extension ROM). Data collected from surgeon's note
  measure: SF-36 questionnaire
  time frame: up to post operative day 60
  description: The SF-36 measures includes the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH).
  Measured on a scale of 1 to 3, with 1 = "yes limited a lot", 2 = "yes limited a little", 3 = "no not limited at all".
  The total score for each participant is calculated and then all the scores are average across all participants.
  measure: Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
  time frame: at 3 months & 6 months
  description: The Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS) comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination.
  Out of the seven items in the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS), five are symptom related and two are examination items.
  If patient reports surgery-related pain greater than 3 on the NRS at the 3 months and 6 months postoperative visit, patient will complete this questionnaire.
  measure: Current opioid misuse measure (COMM)
  time frame: at 3 months & 6 months
  description: The Current Opioid Misuse Measure (COMM) is a commonly used self-report instrument to identify and monitor aberrant opioid-related behavior in chronic pain patients on opioid therapy.
  At the 3 months and 6 months postoperative visit, if patients are still being prescribed opioids, patient will be asked to fill out the questionnaire
  Choices on the questionnaire are:
  never, seldom, sometimes, often, very often
  measure: Incidence of patient contact via text messaging/video calls
  time frame: up to post operative day 4
  description: Research staff will mark if patients contacted the pain doctor via the Diagnotes application.
  measure: Number of unused opioids
  time frame: up to post operative day 7
  description: Patients will be asked at 1 week post-operation, about their pain medication usage (how many pills of your opioid medication do you have left?)
  measure: Pain catastrophizing scale (PCS)
  time frame: before the surgery and up to post operative day 60
  description: The Pain Catastrophizing Scale (PCS) assesses the extent of catastrophic thinking due to low back pain according to 3 components: rumination, magnification, and helplessness. It is a 13-item scale, with a total range of 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.
  measure: Pain Disability Index (PDI)
  time frame: 3 months & 6 months
  description: The Pain Disability Index (PDI) is a widely-used instrument to measure pain-related disability.
  Scoring: Scores are assigned based on an 11-point scale ranging from 0 (no disability) to 10 (total disability). Scores range from 0 to 70. The higher the index the greater the person's disability due to pain.
  measure: Blinding Assessment
  time frame: up to post operative day 2
  description: Patient and research staff will report which group they believe the patient was randomized to.
  measure: Incidents of participants experiencing block complications
  time frame: up to post operative day 4
  description: Data on whether patient experienced quadriceps weakness and foot drop during physical therapy. Collected from physical therapy notes.
  measure: Non Opioid Pain medications consumption
  time frame: up to post operative day 60
  description: Research staff will document any non-opioid pain medications (lyrica, robaxin, tyelnol, etc) taken by each participant. Medications may be given at the discretion of the APS service.
  measure: Intravenous patient control analgesia (IV PCA) usage
  time frame: up to post operative day 7
  description: Research staff will document if patient received IV PCA during their stay at the hospital. Measured in morphine equivalent.
  Discharge times can vary from participant to participant (from POD 0 up until POD 2)
  measure: Length of induction
  time frame: During the surgical procedure
  description: The time it takes for the patient to be induced. Measured from induction start to induction end.
  Times for each participants will be calculated (in minutes) and then average across all participants.
  measure: Length of tourniquet use
  time frame: During the surgical procedure
  description: The total time to use a tourniquet. Measured from tourniquet inflated time tourniquet deflated time.
  Times for each participants will be calculated (in minutes) and then average across all participants.
  arm group label: Adductor Canal Catheter (ACC) - Interventional
  arm group type: Experimental
  description: Patients will received the an adductor canal catheter that continuously infuses numbing medication to their operative leg for 50 hours post-surgery.
  Patients will also communicate with their pain doctor via the Diagnotes application while the catheter is in place.
  arm group label: Adductor Canal Block (ACB) - Control
  arm group type: Sham Comparator
  description: Patients will received the a sham adductor canal catheter that is attached to their operative leg for 50 hours post-surgery.
  Patients will also communicate with their pain doctor via the Diagnotes application while the catheter is in place.
  intervention type: Device
  intervention name: ambIT pump with catheter
  description: 0.2% ropivacaine will be infused through a catheter pump at a rate of 10 ml/hr, 600 ml reservoir.
  arm group label: Adductor Canal Catheter (ACC) - Interventional
  intervention type: Device
  intervention name: ambIT pump with sham catheter
  description: sham catheter with no infusion
  arm group label: Adductor Canal Block (ACB) - Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Stavros Memtsoudis, MD/PhD
  role: Principal Investigator
  affiliation: Hospital for Special Surgery, New York
  last name: Justas Lauzadis, PhD
  role: Study Director
  affiliation: Hospital for Special Surgery, New York
  last name: Justas Lauzadis, PhD
  phone: 212-774-2946
  email: lauzadisj@hss.edu
  last name: Stavros Memtsoudis, MD/PhD
  phone: 212-606-1036
  email: memtsoudiss@hss.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  citation: Katz J, Weinrib A, Fashler SR, Katznelzon R, Shah BR, Ladak SS, Jiang J, Li Q, McMillan K, Santa Mina D, Wentlandt K, McRae K, Tamir D, Lyn S, de Perrot M, Rao V, Grant D, Roche-Nagle G, Cleary SP, Hofer SO, Gilbert R, Wijeysundera D, Ritvo P, Janmohamed T, O'Leary G, Clarke H. The Toronto General Hospital Transitional Pain Service: development and implementation of a multidisciplinary program to prevent chronic postsurgical pain. J Pain Res. 2015 Oct 12;8:695-702. doi: 10.2147/JPR.S91924. eCollection 2015.
  PMID: 26508886
  citation: Chen YK, Boden KA, Schreiber KL. The role of regional anaesthesia and multimodal analgesia in the prevention of chronic postoperative pain: a narrative review. Anaesthesia. 2021 Jan;76 Suppl 1(Suppl 1):8-17. doi: 10.1111/anae.15256.
  PMID: 33426669
  citation: Benthien JP, Huebner D. Efficacy of continuous catheter analgesia of the sciatic nerve after total knee arthroplasty. Swiss Med Wkly. 2015 Feb 19;145:w14119. doi: 10.4414/smw.2015.14119. eCollection 2015.
  PMID: 25695308
  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: Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.
  PMID: 15866968
  citation: Wainwright TW, Gill M, McDonald DA, Middleton RG, Reed M, Sahota O, Yates P, Ljungqvist O. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Feb;91(1):3-19. doi: 10.1080/17453674.2019.1683790. Epub 2019 Oct 30.
  PMID: 31663402
  citation: Kovalak E, Dogan AT, Uzumcugil O, Obut A, Yildiz AS, Kanay E, Tuzuner T, Ozyuvaci E. A comparison of continuous femoral nerve block and periarticular local infiltration analgesia in the management of early period pain developing after total knee arthroplasty. Acta Orthop Traumatol Turc. 2015;49(3):260-6. doi: 10.3944/AOTT.2015.14.0263.
  PMID: 26200404
  citation: Horn BJ, Cien A, Reeves NP, Pathak P, Taunt CJ Jr. Femoral Nerve Block vs Periarticular Bupivacaine Liposome Injection After Primary Total Knee Arthroplasty: Effect on Patient Outcomes. J Am Osteopath Assoc. 2015 Dec;115(12):714-9. doi: 10.7556/jaoa.2015.146.
  PMID: 26618816
  citation: Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.
  PMID: 24401769
  responsible party type: Sponsor
  mesh term: Chronic Pain
  sharing ipd: No
  ipd description: No plan to share IPD with other researchers.
  provided document: 