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/NCT05974501</url>
    </required_header>
    <id_info>
      <org_study_id>20230147</org_study_id>
      <nct_id>NCT05974501</nct_id>
    </id_info>
    <brief_title>Pre vs Post Block in Total Knee Arthroplasty (TKA)</brief_title>
    <official_title>Pre vs. Postoperative Adductor Canal Block for Total Knee Arthroplasty: Prospective Randomized Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Miami</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Miami</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this project is to determine if a change in patient reported pain, nausea and&#xD;
        vomiting after total knee arthroplasty can be observed with the substitution of a post&#xD;
        operative adductor canal block for a preoperative adductor canal block in the current&#xD;
        established peri-operative pain protocol and if these changes lead to a decrease in opioid&#xD;
        consumption (in morphine equivalents).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in pain status as measured by Numeric Pain Scale</measure>
      <time_frame>Baseline, up to 24 hours</time_frame>
      <description>Likert Scale with numeric scores ranging from 0 (least) to 10 (most) pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of patients reporting vomiting</measure>
      <time_frame>Up to 24 hours</time_frame>
      <description>Count of patients reporting vomiting and number of episodes of vomiting</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients reporting nausea</measure>
      <time_frame>Up to 24 hours</time_frame>
      <description>Count of patients reporting nausea and number of episodes of nausea</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of hospital stay</measure>
      <time_frame>Up to 72 hours</time_frame>
      <description>Count of time patient stays in hospital after surgery in hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total opioid consumption in the immediate post-operative period</measure>
      <time_frame>Up to 24 hours</time_frame>
      <description>Measure the amount of morphine milliequivalents consumed by patient</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">84</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <condition>Arthroplasty Complications</condition>
    <condition>Postoperative Pain</condition>
    <arm_group>
      <arm_group_label>Preoperative Adductor Canal Block Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Postoperative Adductor Canal Block Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexamethasone</intervention_name>
      <description>Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling</description>
      <arm_group_label>Postoperative Adductor Canal Block Group</arm_group_label>
      <arm_group_label>Preoperative Adductor Canal Block Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Acetaminophen</intervention_name>
      <description>1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively</description>
      <arm_group_label>Postoperative Adductor Canal Block Group</arm_group_label>
      <arm_group_label>Preoperative Adductor Canal Block Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Lyrica</intervention_name>
      <description>Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively</description>
      <arm_group_label>Postoperative Adductor Canal Block Group</arm_group_label>
      <arm_group_label>Preoperative Adductor Canal Block Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Celebrex</intervention_name>
      <description>200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively</description>
      <arm_group_label>Postoperative Adductor Canal Block Group</arm_group_label>
      <arm_group_label>Preoperative Adductor Canal Block Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Meloxicam</intervention_name>
      <description>30mg administered via IV once postoperatively within 24 hours for pain and swelling</description>
      <arm_group_label>Postoperative Adductor Canal Block Group</arm_group_label>
      <arm_group_label>Preoperative Adductor Canal Block Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oxycodone</intervention_name>
      <description>5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively</description>
      <arm_group_label>Postoperative Adductor Canal Block Group</arm_group_label>
      <arm_group_label>Preoperative Adductor Canal Block Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ropivacaine</intervention_name>
      <description>20 milliliters Ropivacaine 0.2% administered via injection perioperatively.</description>
      <arm_group_label>Postoperative Adductor Canal Block Group</arm_group_label>
      <arm_group_label>Preoperative Adductor Canal Block Group</arm_group_label>
      <other_name>Adductor Canal Block</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1- Patients 18 or older 2 - Patients undergoing primary total knee replacement at the&#xD;
          University of Miami Hospital 3 - Patients that have capacity to provide medical consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. All patients under the age of 18&#xD;
  &#xD;
            2. Prisoners, uncontrolled diabetics, increased risk of bleeding, pregnant women, women&#xD;
               planning on becoming pregnant in the next year, and women who think they might be&#xD;
               pregnant.&#xD;
  &#xD;
            3. Patients with prior surgery or history of infection on the joint of interest.&#xD;
  &#xD;
            4. Patients on steroid preoperatively.&#xD;
  &#xD;
            5. Inability to provide medical consent.&#xD;
  &#xD;
            6. Patients with a history of significant unmitigated pain in parts of their body not&#xD;
               including the knee the procedure is to be performed or a history of pain&#xD;
               catastrophizing (the tendency to magnify the threat value of the pain stimulus and to&#xD;
               feel helpless in the context of pain, and by a relative inability to inhibit&#xD;
               pain-related thoughts in anticipation of, during or following a painful event)&#xD;
               regarding pain anywhere in the body.&#xD;
  &#xD;
            7. Any condition that, in the opinion of the investigator, would compromise the&#xD;
               well-being of the patient or the study or prevent the patient from meeting or&#xD;
               performing study requirements will exclude the participant.&#xD;
  &#xD;
            8. Allergy to local anesthetic or any medication used in the standard protocol for joint&#xD;
               replacement.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Victor H. Hernandez, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Miami</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Victor H. Hernandez, MD</last_name>
      <phone>305-243-4000</phone>
      <email>vhh1@med.miami.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Miami</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33136</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Joseph Costello, BS</last_name>
        <phone>305-243-4000</phone>
        <email>jpc251@med.miami.edu</email>
      </contact>
      <investigator>
        <last_name>Victor H Hernandez, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 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">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Miami</investigator_affiliation>
      <investigator_full_name>Victor Hugo Hernandez</investigator_full_name>
      <investigator_title>Professor of Clinical</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acetaminophen</mesh_term>
      <mesh_term>Dexamethasone</mesh_term>
      <mesh_term>Celecoxib</mesh_term>
      <mesh_term>Meloxicam</mesh_term>
      <mesh_term>Oxycodone</mesh_term>
      <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/NCT05974501
  org study id: 20230147
  nct id: NCT05974501
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The purpose of this project is to determine if a change in patient reported pain, nausea and
        vomiting after total knee arthroplasty can be observed with the substitution of a post
        operative adductor canal block for a preoperative adductor canal block in the current
        established peri-operative pain protocol and if these changes lead to a decrease in opioid
        consumption (in morphine equivalents).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Change in pain status as measured by Numeric Pain Scale
  time frame: Baseline, up to 24 hours
  description: Likert Scale with numeric scores ranging from 0 (least) to 10 (most) pain
  measure: Number of patients reporting vomiting
  time frame: Up to 24 hours
  description: Count of patients reporting vomiting and number of episodes of vomiting
  measure: Number of patients reporting nausea
  time frame: Up to 24 hours
  description: Count of patients reporting nausea and number of episodes of nausea
  measure: Duration of hospital stay
  time frame: Up to 72 hours
  description: Count of time patient stays in hospital after surgery in hours
  measure: Total opioid consumption in the immediate post-operative period
  time frame: Up to 24 hours
  description: Measure the amount of morphine milliequivalents consumed by patient
  arm group label: Preoperative Adductor Canal Block Group
  arm group type: Active Comparator
  description: Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery.
  arm group label: Postoperative Adductor Canal Block Group
  arm group type: Experimental
  description: Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours
  intervention type: Drug
  intervention name: Dexamethasone
  description: Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling
  arm group label: Postoperative Adductor Canal Block Group
  arm group label: Preoperative Adductor Canal Block Group
  intervention type: Drug
  intervention name: Acetaminophen
  description: 1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively
  arm group label: Postoperative Adductor Canal Block Group
  arm group label: Preoperative Adductor Canal Block Group
  intervention type: Drug
  intervention name: Lyrica
  description: Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively
  arm group label: Postoperative Adductor Canal Block Group
  arm group label: Preoperative Adductor Canal Block Group
  intervention type: Drug
  intervention name: Celebrex
  description: 200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively
  arm group label: Postoperative Adductor Canal Block Group
  arm group label: Preoperative Adductor Canal Block Group
  intervention type: Drug
  intervention name: Meloxicam
  description: 30mg administered via IV once postoperatively within 24 hours for pain and swelling
  arm group label: Postoperative Adductor Canal Block Group
  arm group label: Preoperative Adductor Canal Block Group
  intervention type: Drug
  intervention name: Oxycodone
  description: 5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively
  arm group label: Postoperative Adductor Canal Block Group
  arm group label: Preoperative Adductor Canal Block Group
  intervention type: Drug
  intervention name: Ropivacaine
  description: 20 milliliters Ropivacaine 0.2% administered via injection perioperatively.
  arm group label: Postoperative Adductor Canal Block Group
  arm group label: Preoperative Adductor Canal Block Group
  other name: Adductor Canal Block
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Victor H. Hernandez, MD
  role: Principal Investigator
  affiliation: University of Miami
  last name: Victor H. Hernandez, MD
  phone: 305-243-4000
  email: vhh1@med.miami.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Miami
  investigator full name: Victor Hugo Hernandez
  investigator title: Professor of Clinical
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  mesh term: Pain, Postoperative
  mesh term: Acetaminophen
  mesh term: Dexamethasone
  mesh term: Celecoxib
  mesh term: Meloxicam
  mesh term: Oxycodone
  mesh term: Ropivacaine
  sharing ipd: No