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/NCT05980546</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0063</org_study_id>
      <nct_id>NCT05980546</nct_id>
    </id_info>
    <brief_title>Genicular and Anterior Femoral Cutaneous Nerve Blocks for Total Knee Arthroplasty</brief_title>
    <official_title>A Randomized Controlled Trial of Ultrasound Guided Knee Genicular Nerve Block and Anterior Femoral Cutaneous Nerve Block for Primary Total Knee Arthroplasty</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>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 goal of this randomized controlled trial is to examine if there is a relationship between&#xD;
        the addition of the genicular nerve block and anterior femoral cutaneous nerve block in&#xD;
        providing analgesia and the use of oral and intravenous medication in patients undergoing a&#xD;
        total knee arthroplasty. The main questions it aims to answer are:&#xD;
  &#xD;
          1. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to&#xD;
             our current standard of care reduce patients' total opioid consumption in the first 24&#xD;
             hours after total knee arthroplasty (TKA) surgery?&#xD;
  &#xD;
          2. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to&#xD;
             our current standard of care reduce patients' worst numeric rating scale (NRS) pain&#xD;
             score in the post-anesthesia care unit (PACU)?&#xD;
  &#xD;
          3. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to&#xD;
             our current standard of care result in earlier discharge from the post-anesthesia care&#xD;
             unit (PACU)?&#xD;
  &#xD;
          4. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to&#xD;
             our current standard of care reduce patients' total opioid consumption in the first 7&#xD;
             days after total knee arthroplasty (TKA) surgery?&#xD;
  &#xD;
          5. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to&#xD;
             our current standard of care reduce patients' numerical rating scale (NRS) pain (both at&#xD;
             rest and during movement) in the first 24 and 48 hours after surgery?&#xD;
  &#xD;
        Participants will be randomly assigned to receive the genicular nerve block and anterior&#xD;
        femoral cutaneous nerve block in addition to standard of care (intervention group), or not&#xD;
        receive the nerve blocks (control group).&#xD;
  &#xD;
        Comparing the intervention group to the control group, the researcher's primary outcomes are&#xD;
        numerical pain in the post-anesthesia care unit and cumulative opioid consumption during the&#xD;
        first 24 hours.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Adductor canal nerve block (ACB), infiltration between the popliteal artery and the posterior&#xD;
        knee capsule (IPACK), with or without peri-articular infiltration of local anesthetics (PAI),&#xD;
        is the current standard of practice for analgesia coverage after total knee arthroplasty at&#xD;
        the Hospital for Special Surgery. However, we frequently see patients with moderate&#xD;
        post-operative knee pain, particularly on the anterior, middle, and lateral sides of the&#xD;
        knee. There is limited clinical research on if adding a genicular nerve block could offer TKA&#xD;
        patients a more complete analgesia. This study will test if the addition of genicular nerve&#xD;
        block (including superolateral genicular nerve, superomedial genicular nerve, inferomedial&#xD;
        genicular nerve, and nerve to vastus intermedius) and anterior femoral cutaneous nerve block&#xD;
        could offer TKA patients a more complete analgesia. Participants will be randomly assigned to&#xD;
        receive the genicular nerve block and anterior femoral cutaneous nerve block in addition to&#xD;
        standard of care (intervention group), or not receive the nerve blocks (control group).&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          1. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to&#xD;
             our current standard of care reduce patients' total opioid consumption in the first 24&#xD;
             hours after total knee arthroplasty (TKA) surgery?&#xD;
  &#xD;
          2. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to&#xD;
             our current standard of care reduce patients' worst numeric rating scale (NRS) pain&#xD;
             score in the post-anesthesia care unit (PACU)?&#xD;
  &#xD;
          3. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to&#xD;
             our current standard of care result in earlier discharge from the post-anesthesia care&#xD;
             unit (PACU)?&#xD;
  &#xD;
          4. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to&#xD;
             our current standard of care reduce patients' total opioid consumption in the first 7&#xD;
             days after total knee arthroplasty (TKA) surgery?&#xD;
  &#xD;
          5. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to&#xD;
             our current standard of care reduce patients' numerical rating scale (NRS) pain (both at&#xD;
             rest and during movement) in the first 24 and 48 hours after surgery?&#xD;
  &#xD;
        Participants will be randomly assigned to receive the genicular nerve block and anterior&#xD;
        femoral cutaneous nerve block in addition to standard of care (intervention group), or not&#xD;
        receive the nerve blocks (control group).&#xD;
  &#xD;
        Comparing the intervention group to the control group, the researcher's primary outcomes are&#xD;
        numerical pain in the post-anesthesia care unit and cumulative opioid consumption during the&#xD;
        first 24 hours.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 7, 2023</start_date>
    <completion_date type="Anticipated">May 22, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 22, 2025</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>
      <intervention_model_description>A randomized control trial of two groups, intervention vs. control.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Once an individual enrolls, research staff will give the anesthesiologist (a co-investigator) an opaque envelope. Inside the envelope will be an index card to let them know which group the participant is assigned to (intervention or control).&#xD;
  Those who will be blinded as to which group the participant is assigned to are:&#xD;
  Participant&#xD;
  Research personnel (research assistants)&#xD;
  Those who will not be blinded as to which group the participant is assigned to are:&#xD;
  Primary Investigator&#xD;
  Co-investigator&#xD;
  Biostatistician</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Numerical Rating Scale (NRS) pain score</measure>
      <time_frame>in the post-operative care unit (PACU) up to 24 hours after surgery end</time_frame>
      <description>The numeric rating scale (NRS) is a pain screening tool used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning &quot;no pain&quot; and 10 meaning &quot;the worst pain imaginable&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cumulative opioid consumption</measure>
      <time_frame>24 hours after surgery end</time_frame>
      <description>The cumulative opioid consumption measured in oral morphine equivalent (OME).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Numerical Rating Scale (NRS) pain score</measure>
      <time_frame>at post operative day 1 and post operative day 2</time_frame>
      <description>The numeric rating scale (NRS) is a pain screening tool used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning &quot;no pain&quot; and 10 meaning &quot;the worst pain imaginable&quot;.&#xD;
  Although measured at different time points the average score at each time point is reported among all participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative opioid consumption</measure>
      <time_frame>at post operative day 1, 2, &amp; 7</time_frame>
      <description>The cumulative opioid consumption measured in oral morphine equivalent (OME).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brief Pain Inventory (short form)</measure>
      <time_frame>in the post-operative care unit (PACU), up to 24 hours after surgery end and at 7 days after the day of surgery</time_frame>
      <description>The Brief Pain Inventory - Short Form (BPI-sf) is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. Measured on a scale from 0 to 10.&#xD;
  Scoring:&#xD;
  1 - 4 = Mild Pain 5 - 6 = Moderate Pain 7 - 10 = Severe Pain&#xD;
  Although measured at different time points the average score at each time point is reported among all participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant satisfaction with pain treatment</measure>
      <time_frame>in the post-operative care unit (PACU), up to 24 hours after surgery end and at 7 days after the day of surgery</time_frame>
      <description>To assess patients' satisfaction with their pain management. Measured on a scale from 0 to 10, with 0 = strongly dissatisfied and 10 = strongly satisfied.&#xD;
  Although measured at different time points the average score at each time point is reported among all participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readiness for home discharge</measure>
      <time_frame>from induction end (time zero) to readiness for discharge time, up to 7 days</time_frame>
      <description>From time zero, the time when the patient is ready for discharge. Time zero corresponds to the time when anesthesia induction is complete (induction end). A subgroup analysis for this outcome is planned, with 1) a primary analysis of all patients discharged on the day of surgery and 2) a secondary analysis of all patients discharged 23 hours after time zero or whose status was changed to inpatient.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bang Blinding Index</measure>
      <time_frame>at 7 days after surgery</time_frame>
      <description>To assess the success of patient and research staff blinding using the bang blinding index.&#xD;
  The Bang Blinding Index is calculated per treatment arm, is a continuous value such that -1 &lt;= Bang BI &lt;= 1. If the index is 1, all responses are correct, and complete unblinding is inferred.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">244</enrollment>
    <condition>Total Knee Replacement</condition>
    <condition>Genicular Nerve Block</condition>
    <condition>Opioid Use</condition>
    <arm_group>
      <arm_group_label>Group 1 Standard TKA</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The standard TKA group will receive the standard of care analgesia. Those in the control group will be given 7 mg of the preservative dexamethasone intravenously.&#xD;
  The standard group will be given 2-5 mg of intravenous midazolam and up to 100 mcg fentanyl for sedation and analgesia while the peripheral nerve blocks and spinal anesthesia are being performed. All patients will receive a spinal anesthetic (1.5% mepivacaine 52.5 - 60mg) as well as the standard adductor canal block and infiltration between the popliteal artery and posterior knee capsule block (20 ml of 0.25% bupivacaine with 2 mg preservative free dexamethasone for each block).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 Genicular TKA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The genicular group will receive the study intervention of a genicular nerve block and anterior femoral cutaneous nerve block. The intervention group (genicular nerve block/anterior femoral cutaneous nerve block) will receive additional nerve blocks totaling 30 ml of 0.25% bupivacaine with 4 mg preservative-free dexamethasone (5 ml for each block: SMGN, IMGN, SLGN, NVI; 10ml for AFCN).&#xD;
  The genicular group will be given 2-5 mg of intravenous midazolam and up to 100 mcg fentanyl for sedation and analgesia while the peripheral nerve blocks and spinal anesthesia are being performed. All patients will receive a spinal anesthetic (1.5% mepivacaine 52.5 - 60mg) and the standard adductor canal block and infiltration between the popliteal artery and posterior knee capsule block (20 ml of 0.25% bupivacaine with 2 mg preservative free dexamethasone for each block).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacaine Injection</intervention_name>
      <description>The genicular nerve block and anterior femoral cutaneous nerve blocks consists of bupivacaine with preservative-free dexamethasone injections.</description>
      <arm_group_label>Group 2 Genicular TKA</arm_group_label>
      <other_name>Marcaine</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexamethasone injection</intervention_name>
      <description>The genicular nerve block and anterior femoral cutaneous nerve blocks consists of bupivacaine with preservative-free dexamethasone injections.</description>
      <arm_group_label>Group 2 Genicular TKA</arm_group_label>
      <other_name>Ozurdex</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fentanyl</intervention_name>
      <description>This is a drug that is given as part of the analgesia and sedation regime. This drug is not the study intervention.</description>
      <arm_group_label>Group 2 Genicular TKA</arm_group_label>
      <other_name>Actiq</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Mepivacaine</intervention_name>
      <description>This is a drug that is given as part of the analgesia and sedation regime. This drug is not the study intervention.</description>
      <arm_group_label>Group 2 Genicular TKA</arm_group_label>
      <other_name>Carbocaine</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients age 18-80&#xD;
  &#xD;
            -  patients undergoing ambulatory unilateral total knee arthroplasty, including 23 hour&#xD;
               stay cohort&#xD;
  &#xD;
            -  ASA I-III&#xD;
  &#xD;
            -  BMI &lt; 35&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  history of chronic pain syndromes&#xD;
  &#xD;
            -  chronic opioid use (daily morphine milligram equivalents &gt; 30 mg for at least 3&#xD;
               months)&#xD;
  &#xD;
            -  contraindication to peripheral nerve blocks&#xD;
  &#xD;
            -  contraindication to neuraxial anesthesia&#xD;
  &#xD;
            -  history of peripheral neuropathy or pre-existing neurological deficits&#xD;
  &#xD;
            -  Psychiatrics or cognitive disorder that prohibit patient from following study protocol&#xD;
  &#xD;
            -  allergy to local anesthetic or study medications&#xD;
  &#xD;
            -  multiligament surgery&#xD;
  &#xD;
            -  history of substance abuse&#xD;
  &#xD;
            -  infection at the site of injection&#xD;
  &#xD;
            -  chronic kidney disease&#xD;
  &#xD;
            -  currently taking anticonvulsants&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jiabin Liu, MD/PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital for Special Surgery, New York</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pa Thor, PhD</last_name>
      <phone>646-797-8535</phone>
      <email>thorp@hss.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Justas Lauzadis, PhD</last_name>
      <phone>212-774-2946</phone>
      <email>lauzadisj@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>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <results_reference>
      <citation>Conger A, Gililland J, Anderson L, Pelt CE, Peters C, McCormick ZL. Genicular Nerve Radiofrequency Ablation for the Treatment of Painful Knee Osteoarthritis: Current Evidence and Future Directions. Pain Med. 2021 Jul 25;22(Suppl 1):S20-S23. doi: 10.1093/pm/pnab129.</citation>
      <PMID>34308957</PMID>
    </results_reference>
    <results_reference>
      <citation>Kim DH, Choi SS, Yoon SH, Lee SH, Seo DK, Lee IG, Choi WJ, Shin JW. Ultrasound-Guided Genicular Nerve Block for Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial of Local Anesthetic Alone or in Combination with Corticosteroid. Pain Physician. 2018 Jan;21(1):41-52.</citation>
      <PMID>29357330</PMID>
    </results_reference>
    <results_reference>
      <citation>Rambhia M, Chen A, Kumar AH, Bullock WM, Bolognesi M, Gadsden J. Ultrasound-guided genicular nerve blocks following total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Oct;46(10):862-866. doi: 10.1136/rapm-2021-102667. Epub 2021 Jul 14.</citation>
      <PMID>34261807</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 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexamethasone</mesh_term>
      <mesh_term>Dexamethasone acetate</mesh_term>
      <mesh_term>Fentanyl</mesh_term>
      <mesh_term>Bupivacaine</mesh_term>
      <mesh_term>Mepivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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>May 23, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT05980546/Prot_SAP_001.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/NCT05980546
  org study id: 2023-0063
  nct id: NCT05980546
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The goal of this randomized controlled trial is to examine if there is a relationship between
        the addition of the genicular nerve block and anterior femoral cutaneous nerve block in
        providing analgesia and the use of oral and intravenous medication in patients undergoing a
        total knee arthroplasty. The main questions it aims to answer are:
  
          1. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to
             our current standard of care reduce patients' total opioid consumption in the first 24
             hours after total knee arthroplasty (TKA) surgery?
  
          2. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to
             our current standard of care reduce patients' worst numeric rating scale (NRS) pain
             score in the post-anesthesia care unit (PACU)?
  
          3. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to
             our current standard of care result in earlier discharge from the post-anesthesia care
             unit (PACU)?
  
          4. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to
             our current standard of care reduce patients' total opioid consumption in the first 7
             days after total knee arthroplasty (TKA) surgery?
  
          5. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to
             our current standard of care reduce patients' numerical rating scale (NRS) pain (both at
             rest and during movement) in the first 24 and 48 hours after surgery?
  
        Participants will be randomly assigned to receive the genicular nerve block and anterior
        femoral cutaneous nerve block in addition to standard of care (intervention group), or not
        receive the nerve blocks (control group).
  
        Comparing the intervention group to the control group, the researcher's primary outcomes are
        numerical pain in the post-anesthesia care unit and cumulative opioid consumption during the
        first 24 hours.
  Adductor canal nerve block (ACB), infiltration between the popliteal artery and the posterior
        knee capsule (IPACK), with or without peri-articular infiltration of local anesthetics (PAI),
        is the current standard of practice for analgesia coverage after total knee arthroplasty at
        the Hospital for Special Surgery. However, we frequently see patients with moderate
        post-operative knee pain, particularly on the anterior, middle, and lateral sides of the
        knee. There is limited clinical research on if adding a genicular nerve block could offer TKA
        patients a more complete analgesia. This study will test if the addition of genicular nerve
        block (including superolateral genicular nerve, superomedial genicular nerve, inferomedial
        genicular nerve, and nerve to vastus intermedius) and anterior femoral cutaneous nerve block
        could offer TKA patients a more complete analgesia. Participants will be randomly assigned to
        receive the genicular nerve block and anterior femoral cutaneous nerve block in addition to
        standard of care (intervention group), or not receive the nerve blocks (control group).
  
        The main questions it aims to answer are:
  
          1. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to
             our current standard of care reduce patients' total opioid consumption in the first 24
             hours after total knee arthroplasty (TKA) surgery?
  
          2. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to
             our current standard of care reduce patients' worst numeric rating scale (NRS) pain
             score in the post-anesthesia care unit (PACU)?
  
          3. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to
             our current standard of care result in earlier discharge from the post-anesthesia care
             unit (PACU)?
  
          4. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to
             our current standard of care reduce patients' total opioid consumption in the first 7
             days after total knee arthroplasty (TKA) surgery?
  
          5. Does incorporating genicular nerve block and anterior femoral cutaneous nerve block to
             our current standard of care reduce patients' numerical rating scale (NRS) pain (both at
             rest and during movement) in the first 24 and 48 hours after surgery?
  
        Participants will be randomly assigned to receive the genicular nerve block and anterior
        femoral cutaneous nerve block in addition to standard of care (intervention group), or not
        receive the nerve blocks (control group).
  
        Comparing the intervention group to the control group, the researcher's primary outcomes are
        numerical pain in the post-anesthesia care unit and cumulative opioid consumption during the
        first 24 hours.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A randomized control trial of two groups, intervention vs. control.
  primary purpose: Other
  masking: Double (Participant, Outcomes Assessor)
  masking description: Once an individual enrolls, research staff will give the anesthesiologist (a co-investigator) an opaque envelope. Inside the envelope will be an index card to let them know which group the participant is assigned to (intervention or control).
  Those who will be blinded as to which group the participant is assigned to are:
  Participant
  Research personnel (research assistants)
  Those who will not be blinded as to which group the participant is assigned to are:
  Primary Investigator
  Co-investigator
  Biostatistician
  measure: Numerical Rating Scale (NRS) pain score
  time frame: in the post-operative care unit (PACU) up to 24 hours after surgery end
  description: The numeric rating scale (NRS) is a pain screening tool used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
  measure: Cumulative opioid consumption
  time frame: 24 hours after surgery end
  description: The cumulative opioid consumption measured in oral morphine equivalent (OME).
  measure: Numerical Rating Scale (NRS) pain score
  time frame: at post operative day 1 and post operative day 2
  description: The numeric rating scale (NRS) is a pain screening tool used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
  Although measured at different time points the average score at each time point is reported among all participants.
  measure: Cumulative opioid consumption
  time frame: at post operative day 1, 2, & 7
  description: The cumulative opioid consumption measured in oral morphine equivalent (OME).
  measure: Brief Pain Inventory (short form)
  time frame: in the post-operative care unit (PACU), up to 24 hours after surgery end and at 7 days after the day of surgery
  description: The Brief Pain Inventory - Short Form (BPI-sf) is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. Measured on a scale from 0 to 10.
  Scoring:
  1 - 4 = Mild Pain 5 - 6 = Moderate Pain 7 - 10 = Severe Pain
  Although measured at different time points the average score at each time point is reported among all participants.
  measure: Participant satisfaction with pain treatment
  time frame: in the post-operative care unit (PACU), up to 24 hours after surgery end and at 7 days after the day of surgery
  description: To assess patients' satisfaction with their pain management. Measured on a scale from 0 to 10, with 0 = strongly dissatisfied and 10 = strongly satisfied.
  Although measured at different time points the average score at each time point is reported among all participants.
  measure: Readiness for home discharge
  time frame: from induction end (time zero) to readiness for discharge time, up to 7 days
  description: From time zero, the time when the patient is ready for discharge. Time zero corresponds to the time when anesthesia induction is complete (induction end). A subgroup analysis for this outcome is planned, with 1) a primary analysis of all patients discharged on the day of surgery and 2) a secondary analysis of all patients discharged 23 hours after time zero or whose status was changed to inpatient.
  measure: Bang Blinding Index
  time frame: at 7 days after surgery
  description: To assess the success of patient and research staff blinding using the bang blinding index.
  The Bang Blinding Index is calculated per treatment arm, is a continuous value such that -1 <= Bang BI <= 1. If the index is 1, all responses are correct, and complete unblinding is inferred.
  arm group label: Group 1 Standard TKA
  arm group type: No Intervention
  description: The standard TKA group will receive the standard of care analgesia. Those in the control group will be given 7 mg of the preservative dexamethasone intravenously.
  The standard group will be given 2-5 mg of intravenous midazolam and up to 100 mcg fentanyl for sedation and analgesia while the peripheral nerve blocks and spinal anesthesia are being performed. All patients will receive a spinal anesthetic (1.5% mepivacaine 52.5 - 60mg) as well as the standard adductor canal block and infiltration between the popliteal artery and posterior knee capsule block (20 ml of 0.25% bupivacaine with 2 mg preservative free dexamethasone for each block).
  arm group label: Group 2 Genicular TKA
  arm group type: Experimental
  description: The genicular group will receive the study intervention of a genicular nerve block and anterior femoral cutaneous nerve block. The intervention group (genicular nerve block/anterior femoral cutaneous nerve block) will receive additional nerve blocks totaling 30 ml of 0.25% bupivacaine with 4 mg preservative-free dexamethasone (5 ml for each block: SMGN, IMGN, SLGN, NVI; 10ml for AFCN).
  The genicular group will be given 2-5 mg of intravenous midazolam and up to 100 mcg fentanyl for sedation and analgesia while the peripheral nerve blocks and spinal anesthesia are being performed. All patients will receive a spinal anesthetic (1.5% mepivacaine 52.5 - 60mg) and the standard adductor canal block and infiltration between the popliteal artery and posterior knee capsule block (20 ml of 0.25% bupivacaine with 2 mg preservative free dexamethasone for each block).
  intervention type: Drug
  intervention name: Bupivacaine Injection
  description: The genicular nerve block and anterior femoral cutaneous nerve blocks consists of bupivacaine with preservative-free dexamethasone injections.
  arm group label: Group 2 Genicular TKA
  other name: Marcaine
  intervention type: Drug
  intervention name: Dexamethasone injection
  description: The genicular nerve block and anterior femoral cutaneous nerve blocks consists of bupivacaine with preservative-free dexamethasone injections.
  arm group label: Group 2 Genicular TKA
  other name: Ozurdex
  intervention type: Drug
  intervention name: Fentanyl
  description: This is a drug that is given as part of the analgesia and sedation regime. This drug is not the study intervention.
  arm group label: Group 2 Genicular TKA
  other name: Actiq
  intervention type: Drug
  intervention name: Mepivacaine
  description: This is a drug that is given as part of the analgesia and sedation regime. This drug is not the study intervention.
  arm group label: Group 2 Genicular TKA
  other name: Carbocaine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Jiabin Liu, MD/PhD
  role: Principal Investigator
  affiliation: Hospital for Special Surgery, New York
  last name: Pa Thor, PhD
  phone: 646-797-8535
  email: thorp@hss.edu
  last name: Justas Lauzadis, PhD
  phone: 212-774-2946
  email: lauzadisj@hss.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  citation: Conger A, Gililland J, Anderson L, Pelt CE, Peters C, McCormick ZL. Genicular Nerve Radiofrequency Ablation for the Treatment of Painful Knee Osteoarthritis: Current Evidence and Future Directions. Pain Med. 2021 Jul 25;22(Suppl 1):S20-S23. doi: 10.1093/pm/pnab129.
  PMID: 34308957
  citation: Kim DH, Choi SS, Yoon SH, Lee SH, Seo DK, Lee IG, Choi WJ, Shin JW. Ultrasound-Guided Genicular Nerve Block for Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial of Local Anesthetic Alone or in Combination with Corticosteroid. Pain Physician. 2018 Jan;21(1):41-52.
  PMID: 29357330
  citation: Rambhia M, Chen A, Kumar AH, Bullock WM, Bolognesi M, Gadsden J. Ultrasound-guided genicular nerve blocks following total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Oct;46(10):862-866. doi: 10.1136/rapm-2021-102667. Epub 2021 Jul 14.
  PMID: 34261807
  responsible party type: Sponsor
  mesh term: Dexamethasone
  mesh term: Dexamethasone acetate
  mesh term: Fentanyl
  mesh term: Bupivacaine
  mesh term: Mepivacaine
  sharing ipd: No
  provided document: 