<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/NCT03774966</url>
  </required_header>
  <id_info>
    <org_study_id>18-001490</org_study_id>
    <nct_id>NCT03774966</nct_id>
  </id_info>
  <brief_title>IPACK and Adductor Canal Catheter Patient Outcomes for TKAs?</brief_title>
  <official_title>Do Patients Who Receive the IPACK and Adductor Canal Catheter Have Better Outcomes Than Patients Receiving the Adductor Canal Catheter Alone for Total Knee Replacements?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the addition of the IPACK block to the adductor canal block and catheter&#xD;
      in the pain management of total knee arthroplasty. Half of participants will receive the&#xD;
      adductor canal block and catheter with the IPACK block, while the other half will receive the&#xD;
      adductor canal block and catheter only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total knee arthroplasty (TKA) is a surgical procedure that can be associated with significant&#xD;
      post-operative pain. Poor pain control in the post-operative period has contributed to delays&#xD;
      in early mobility and rehabilitation, an important part of recovery that is best started as&#xD;
      soon as possible after surgery. Regional techniques in general have helped manage&#xD;
      post-operative pain as well as minimize narcotic use. The application of femoral and sciatic&#xD;
      nerve blocks has been shown to decrease opioid use; however, they were associated with&#xD;
      adverse events such as quadriceps weakness and falls post-operatively. This led to the&#xD;
      development of the adductor canal block (ACB) which has gained favor for providing superior&#xD;
      analgesia over opioids alone, and for the added benefit of sparing the quadriceps muscle.&#xD;
      Recently, adding local anesthetic to the interspace between the popliteal artery and&#xD;
      posterior capsule of the knee (IPACK) blocks have been used to help address pain in the&#xD;
      posterior part of the knee that is not well covered by the adductor canal block alone. While&#xD;
      the sciatic nerve block is also an option to cover this area, it is associated with foot drop&#xD;
      which can hinder early mobility. For patients undergoing TKAs at UCLA, our standard of&#xD;
      practice is the ACB. The investigators hope to show with this study that adopting this novel&#xD;
      block will help with post-operative pain control, decrease length of hospital stay, and&#xD;
      increase distance walked during physical therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">May 28, 2019</completion_date>
  <primary_completion_date type="Actual">May 28, 2019</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid consumption in milligram morphine equivalents</measure>
    <time_frame>4 days</time_frame>
    <description>Total opioid consumption will be calculated for postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day) and total hospital stay. Opioid amount will be converted to morphine equivalents (milligram) for comparison.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analog pain scores</measure>
    <time_frame>4 days</time_frame>
    <description>Pain scores will be assessed postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day) using the visual analog score (Scale 0-10). Zero for no pain and ten being the worst pain experienced. They will be obtained and recorded every 4 to 6 hours by the nurse monitoring the subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance ambulated during physical therapy</measure>
    <time_frame>4 days</time_frame>
    <description>Distance (meters) ambulated during physical therapy will be recorded for postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Surgery</condition>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>Adductor Canal Block + Catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adductor canal block: 15 mL of 0.25% ropivicaine, adductor canal catheter: 6 mL/hr of 0.2% ropivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adductor Canal Block + Catheter &amp; IPACK</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adductor canal block: 15 mL of 0.25% ropivicaine, adductor canal catheter: 6 mL/hr of 0.2% ropivacaine, IPACK block: 15 ml of 0.25% ropivacaine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Adductor Canal Block + Catheter &amp; IPACK block</intervention_name>
    <description>Adductor Canal Block + Catheter &amp; IPACK block</description>
    <arm_group_label>Adductor Canal Block + Catheter &amp; IPACK</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Adductor canal block + catheter</intervention_name>
    <description>Adductor canal block + catheter</description>
    <arm_group_label>Adductor Canal Block + Catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing total knee replacement without contraindications to regional&#xD;
             blocks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have contraindications to regional blocks: infection at injection site&#xD;
             for the nerve block, allergy to local anesthetics, history of a bleeding disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UCLA Medical Center, Santa Monica</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Cullom C, Weed JT. Anesthetic and Analgesic Management for Outpatient Knee Arthroplasty. Curr Pain Headache Rep. 2017 May;21(5):23. doi: 10.1007/s11916-017-0623-y.</citation>
    <PMID>28283810</PMID>
  </reference>
  <results_reference>
    <citation>Thobhani S, Scalercio L, Elliott CE, Nossaman BD, Thomas LC, Yuratich D, Bland K, Osteen K, Patterson ME. Novel Regional Techniques for Total Knee Arthroplasty Promote Reduced Hospital Length of Stay: An Analysis of 106 Patients. Ochsner J. 2017 Fall;17(3):233-238.</citation>
    <PMID>29026354</PMID>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Eva Boyd, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>total knee arthroplasty</keyword>
  <keyword>regional block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03774966
org study id: 18-001490
nct id: NCT03774966
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study evaluates the addition of the IPACK block to the adductor canal block and catheter
      in the pain management of total knee arthroplasty. Half of participants will receive the
      adductor canal block and catheter with the IPACK block, while the other half will receive the
      adductor canal block and catheter only.
Total knee arthroplasty (TKA) is a surgical procedure that can be associated with significant
      post-operative pain. Poor pain control in the post-operative period has contributed to delays
      in early mobility and rehabilitation, an important part of recovery that is best started as
      soon as possible after surgery. Regional techniques in general have helped manage
      post-operative pain as well as minimize narcotic use. The application of femoral and sciatic
      nerve blocks has been shown to decrease opioid use; however, they were associated with
      adverse events such as quadriceps weakness and falls post-operatively. This led to the
      development of the adductor canal block (ACB) which has gained favor for providing superior
      analgesia over opioids alone, and for the added benefit of sparing the quadriceps muscle.
      Recently, adding local anesthetic to the interspace between the popliteal artery and
      posterior capsule of the knee (IPACK) blocks have been used to help address pain in the
      posterior part of the knee that is not well covered by the adductor canal block alone. While
      the sciatic nerve block is also an option to cover this area, it is associated with foot drop
      which can hinder early mobility. For patients undergoing TKAs at UCLA, our standard of
      practice is the ACB. The investigators hope to show with this study that adopting this novel
      block will help with post-operative pain control, decrease length of hospital stay, and
      increase distance walked during physical therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Opioid consumption in milligram morphine equivalents
time frame: 4 days
description: Total opioid consumption will be calculated for postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day) and total hospital stay. Opioid amount will be converted to morphine equivalents (milligram) for comparison.
measure: Visual analog pain scores
time frame: 4 days
description: Pain scores will be assessed postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day) using the visual analog score (Scale 0-10). Zero for no pain and ten being the worst pain experienced. They will be obtained and recorded every 4 to 6 hours by the nurse monitoring the subject.
measure: Distance ambulated during physical therapy
time frame: 4 days
description: Distance (meters) ambulated during physical therapy will be recorded for postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day)
arm group label: Adductor Canal Block + Catheter
arm group type: Active Comparator
description: Adductor canal block: 15 mL of 0.25% ropivicaine, adductor canal catheter: 6 mL/hr of 0.2% ropivacaine
arm group label: Adductor Canal Block + Catheter & IPACK
arm group type: Experimental
description: Adductor canal block: 15 mL of 0.25% ropivicaine, adductor canal catheter: 6 mL/hr of 0.2% ropivacaine, IPACK block: 15 ml of 0.25% ropivacaine.
intervention type: Procedure
intervention name: Adductor Canal Block + Catheter & IPACK block
description: Adductor Canal Block + Catheter & IPACK block
arm group label: Adductor Canal Block + Catheter & IPACK
intervention type: Procedure
intervention name: Adductor canal block + catheter
description: Adductor canal block + catheter
arm group label: Adductor Canal Block + Catheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Cullom C, Weed JT. Anesthetic and Analgesic Management for Outpatient Knee Arthroplasty. Curr Pain Headache Rep. 2017 May;21(5):23. doi: 10.1007/s11916-017-0623-y.
PMID: 28283810
citation: Thobhani S, Scalercio L, Elliott CE, Nossaman BD, Thomas LC, Yuratich D, Bland K, Osteen K, Patterson ME. Novel Regional Techniques for Total Knee Arthroplasty Promote Reduced Hospital Length of Stay: An Analysis of 106 Patients. Ochsner J. 2017 Fall;17(3):233-238.
PMID: 29026354
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Eva Boyd, MD
investigator title: Principal Investigator
mesh term: Acute Pain
sharing ipd: No