<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/NCT03245359</url>
  </required_header>
  <id_info>
    <org_study_id>880424</org_study_id>
    <nct_id>NCT03245359</nct_id>
  </id_info>
  <brief_title>Pain Management After TKA: Comparison of Short- and Long-term Nerve Blocks</brief_title>
  <official_title>Pain Management After TKA: Comparison of Short- and Long-term Concurrent Saphenous (Adductor Canal) and Posterior Nerve Blocks Using the ON-Q Pump System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AdventHealth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Halyard Health</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AdventHealth</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if there is any significant difference between&#xD;
      using a short-term ON-Q nerve block (which is applied prior to surgery and maintained in&#xD;
      place until the medication in the initial balls have been fully used, usually 2-4 days) in&#xD;
      comparison to a long-term ON-Q nerve block (which is applied prior to surgery and maintained&#xD;
      in place up to seven days after surgery). This study will analyze patient reported levels of&#xD;
      pain, range of motion, and narcotic use, as well as investigate whether blood loss, blood&#xD;
      thinners, and hemoglobin/hematocrit blood levels influence patient pain levels.&#xD;
&#xD;
      This study will compare patient-reported pain, range of motion and narcotic use in total knee&#xD;
      arthroplasty patients who receive the short-term and long-term combination nerve block&#xD;
      (saphenous and posterior of the adductor canal and wide-field posterior knee.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-operative pain remains one of the patient's greatest concerns after Total Knee&#xD;
      Arthroplasty (TKA). Insufficient pain control can delay mobilization and inhibit&#xD;
      rehabilitation efforts. Multimodal analgesia, including peripheral nerve block, is&#xD;
      recommended for pain relief, and reaching an effective level of pain management, while&#xD;
      minimizing opioid side effects, is vital to a patient's recovery and satisfaction of care&#xD;
      delivered. The ON-Q pain relief system continually infuses local analgesia for effective pain&#xD;
      relief.&#xD;
&#xD;
      This is a prospective, randomized control trial designed to compare the effects of using the&#xD;
      short-term and long-term combination ON-Q nerve blocks in connection with TKA surgery. The&#xD;
      ON-Q nerve block and pump system provides slowly infused, continuous delivery of a local&#xD;
      anesthetic to the surgical site and nerves. The use of concurrent saphenous and posterior&#xD;
      knee nerve blocks with the ON-Q system has been adopted as standard procedure at our&#xD;
      institute. The study does not involve an alteration to the typical procedures currently being&#xD;
      employed. Ultrasound will ensure the accuracy of catheter placement by a regional&#xD;
      anesthesiologist.&#xD;
&#xD;
      All consecutive TKA patients who meet study criteria will be recruited for enrollment in the&#xD;
      study prior to surgery. Pre-operatively, patients will be asked to complete health&#xD;
      questionnaires, assessments to measure reported pain levels and location, and range of&#xD;
      motion. Home medications will be reviewed, and hemoglobin/hematocrit blood levels will be&#xD;
      recorded. Patients randomized to the long-term group will receive education on how to connect&#xD;
      the ON-Q ball/pump to the catheter using a demonstration set to show understanding of the&#xD;
      skill. Patients in the long-term group will also receive a 750mL ON-Q ball/pump filled with&#xD;
      bupivacaine 0.125% for the select-a-flow saphenous catheter nerve block and a 400mL ON-Q&#xD;
      ball/pump filled with bupivacaine 0.125% for the posterior fixed rate catheter nerve block to&#xD;
      enable the nerve blocks to last up to the 7 days of treatment.&#xD;
&#xD;
      Post-operatively, blood loss, inpatient hemoglobin/hematocrit levels, pain medications&#xD;
      consumed and side effects, range of motion by Physical Therapy, and pain assessments will be&#xD;
      recorded. After discharge, patients will receive daily phone calls up to day 7 post-op to&#xD;
      collect reported pain scores, pain medications consumed and side effects, signs/symptoms of&#xD;
      catheter site infection, and physical therapy or activity for that day. This information, as&#xD;
      well as health questionnaires, will also be collected from both treatment groups at the&#xD;
      2-week and 6-week follow-up office visits.&#xD;
&#xD;
      Data will be analyzed at the conclusion of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Actual">May 20, 2019</completion_date>
  <primary_completion_date type="Actual">January 8, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Day of Surgery Pain Scores at 6 Weeks.</measure>
    <time_frame>This will be collected from day of surgery to 6-weeks postoperative</time_frame>
    <description>This study will assess patient reported pain, as determined by results of the Numeric Pain Rating Scale of 0-10 while knee is at rest and with active bending movement to determine if there is a difference between the short- and long-term groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Opioid and Analgesic Use</measure>
    <time_frame>This will be collected daily from day of surgery through day 7 post-operative.</time_frame>
    <description>Concomitant pain medications consumed while still using the ON-Q nerve block system will be documented, in order to identify reduction/increases in patient's opioid consumption trends.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Experience Common Opioid and Analgesic Side Effects</measure>
    <time_frame>This will be collected daily from day of surgery through day 7 post-operative.</time_frame>
    <description>Concomitant pain medication side effects that are commonly experienced while still using the ON-Q nerve block system will be documented, including nausea, constipation or rash.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Range of Motion (degrees)</measure>
    <time_frame>This will be completed at all inpatient physical therapy sessions on day 1 and 2 post-operative and follow-up office visits at 2 and 6 weeks post-operative.</time_frame>
    <description>Range of motion measured in degrees will be collected. This will be measured by PI and/or Physical Therapy assessments and used to compare whether there is a difference in the participants range of motion between short- and long-term groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life - SF-12</measure>
    <time_frame>This assessment will be collected at 2- and 6-week follow-up office visits.</time_frame>
    <description>Evaluate the patient quality of life through SF-12 assessment score to assess if there is a trending difference between short- and long-term groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life - EQ-5D-5L</measure>
    <time_frame>This assessment will be collected at 2- and 6-week follow-up office visits.</time_frame>
    <description>Evaluate the patient quality of life through EQ-5D-5L assessment score to assess if there is a trending difference between short- and long-term groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants with Intraoperative Blood Loss (mL)</measure>
    <time_frame>Conclusion of Surgery</time_frame>
    <description>Intraoperative blood loss in mL will be collected from patient records</description>
  </other_outcome>
  <other_outcome>
    <measure>Hemoglobin Laboratory Results (grams/deciliter)</measure>
    <time_frame>Hemoglobin and hematocrit laboratory results will be collected from the patient's pre-operative testing laboratory results (within 30 days before surgery) and from post-operative inpatient laboratory results (within 48 hours post-operative).</time_frame>
    <description>Hemoglobin levels will be collected from patient records</description>
  </other_outcome>
  <other_outcome>
    <measure>Hematocrit Laboratory Results (Percentage of Concentration)</measure>
    <time_frame>Hemoglobin and hematocrit laboratory results will be collected from the patient's pre-operative testing laboratory results (within 30 days before surgery) and from post-operative inpatient laboratory results (within 48 hours post-operative).</time_frame>
    <description>Hematocrit levels will be collected from patient records.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Anesthesia, Local</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Short-term ON-Q</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single port, select-a-flow pump and ON-Q 750mL ball filled with bupivacaine 0.125% saphenous (adductor canal) nerve block and single port, fixed flow pump and 400mL ON-Q ball with bupivacaine 0.125% wide field posterior knee block to provide analgesia from surgery until medication has been depleted (typically 2-4 days)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Long-term ON-Q</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single port, select-a-flow pump and two 750mL ON-Q balls filled with bupivacaine 0.125% saphenous (adductor canal) nerve block and single port, fixed flow pump and two 400mL ON-Q ball with bupivacaine 0.125% wide field posterior knee block to provide analgesia from surgery up to 7 days post-operative. The second ball for each location will be provided pre-operatively, along with patient education for connection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Short-term ON-Q</intervention_name>
    <description>single port, select-a-flow pump connected to saphenous nerve block catheter until medication in initial balls are depleted (usually 2-4 days)</description>
    <arm_group_label>Short-term ON-Q</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Short-term ON-Q</intervention_name>
    <description>single port, fixed flow pump connected to posterior knee catheter until medication in initial balls are depleted (usually 2-4 days)</description>
    <arm_group_label>Short-term ON-Q</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Short-term ON-Q</intervention_name>
    <description>Bupivacaine 0.125%</description>
    <arm_group_label>Short-term ON-Q</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Long-term ON-Q</intervention_name>
    <description>single port, select-a-flow pump connected to saphenous nerve block catheter until day 7 post-operative</description>
    <arm_group_label>Long-term ON-Q</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Long-term ON-Q</intervention_name>
    <description>single port, fixed flow pump connected to posterior knee catheter until day 7 post-operative</description>
    <arm_group_label>Long-term ON-Q</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Long-term ON-Q</intervention_name>
    <description>Bupivacaine 0.125%</description>
    <arm_group_label>Long-term ON-Q</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Undergoing elective total knee arthroplasty&#xD;
&#xD;
          -  Able to tolerate both short- and long-term ON-Q therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  History of dementia or mental instability&#xD;
&#xD;
          -  Pregnancy&#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>J. Dean Cole, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>AdventHealth</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Florida Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>March 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 1, 2019</last_update_submitted>
  <last_update_submitted_qc>August 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Total Knee Arthroplasty</keyword>
  <keyword>Intra-articular Analgesia</keyword>
  <keyword>Bupivacaine Hydrochloride</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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/NCT03245359
org study id: 880424
nct id: NCT03245359
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to determine if there is any significant difference between
      using a short-term ON-Q nerve block (which is applied prior to surgery and maintained in
      place until the medication in the initial balls have been fully used, usually 2-4 days) in
      comparison to a long-term ON-Q nerve block (which is applied prior to surgery and maintained
      in place up to seven days after surgery). This study will analyze patient reported levels of
      pain, range of motion, and narcotic use, as well as investigate whether blood loss, blood
      thinners, and hemoglobin/hematocrit blood levels influence patient pain levels.

      This study will compare patient-reported pain, range of motion and narcotic use in total knee
      arthroplasty patients who receive the short-term and long-term combination nerve block
      (saphenous and posterior of the adductor canal and wide-field posterior knee.
Post-operative pain remains one of the patient's greatest concerns after Total Knee
      Arthroplasty (TKA). Insufficient pain control can delay mobilization and inhibit
      rehabilitation efforts. Multimodal analgesia, including peripheral nerve block, is
      recommended for pain relief, and reaching an effective level of pain management, while
      minimizing opioid side effects, is vital to a patient's recovery and satisfaction of care
      delivered. The ON-Q pain relief system continually infuses local analgesia for effective pain
      relief.

      This is a prospective, randomized control trial designed to compare the effects of using the
      short-term and long-term combination ON-Q nerve blocks in connection with TKA surgery. The
      ON-Q nerve block and pump system provides slowly infused, continuous delivery of a local
      anesthetic to the surgical site and nerves. The use of concurrent saphenous and posterior
      knee nerve blocks with the ON-Q system has been adopted as standard procedure at our
      institute. The study does not involve an alteration to the typical procedures currently being
      employed. Ultrasound will ensure the accuracy of catheter placement by a regional
      anesthesiologist.

      All consecutive TKA patients who meet study criteria will be recruited for enrollment in the
      study prior to surgery. Pre-operatively, patients will be asked to complete health
      questionnaires, assessments to measure reported pain levels and location, and range of
      motion. Home medications will be reviewed, and hemoglobin/hematocrit blood levels will be
      recorded. Patients randomized to the long-term group will receive education on how to connect
      the ON-Q ball/pump to the catheter using a demonstration set to show understanding of the
      skill. Patients in the long-term group will also receive a 750mL ON-Q ball/pump filled with
      bupivacaine 0.125% for the select-a-flow saphenous catheter nerve block and a 400mL ON-Q
      ball/pump filled with bupivacaine 0.125% for the posterior fixed rate catheter nerve block to
      enable the nerve blocks to last up to the 7 days of treatment.

      Post-operatively, blood loss, inpatient hemoglobin/hematocrit levels, pain medications
      consumed and side effects, range of motion by Physical Therapy, and pain assessments will be
      recorded. After discharge, patients will receive daily phone calls up to day 7 post-op to
      collect reported pain scores, pain medications consumed and side effects, signs/symptoms of
      catheter site infection, and physical therapy or activity for that day. This information, as
      well as health questionnaires, will also be collected from both treatment groups at the
      2-week and 6-week follow-up office visits.

      Data will be analyzed at the conclusion of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline Day of Surgery Pain Scores at 6 Weeks.
time frame: This will be collected from day of surgery to 6-weeks postoperative
description: This study will assess patient reported pain, as determined by results of the Numeric Pain Rating Scale of 0-10 while knee is at rest and with active bending movement to determine if there is a difference between the short- and long-term groups.
measure: Opioid and Analgesic Use
time frame: This will be collected daily from day of surgery through day 7 post-operative.
description: Concomitant pain medications consumed while still using the ON-Q nerve block system will be documented, in order to identify reduction/increases in patient's opioid consumption trends.
measure: Number of Participants Who Experience Common Opioid and Analgesic Side Effects
time frame: This will be collected daily from day of surgery through day 7 post-operative.
description: Concomitant pain medication side effects that are commonly experienced while still using the ON-Q nerve block system will be documented, including nausea, constipation or rash.
measure: Patient Range of Motion (degrees)
time frame: This will be completed at all inpatient physical therapy sessions on day 1 and 2 post-operative and follow-up office visits at 2 and 6 weeks post-operative.
description: Range of motion measured in degrees will be collected. This will be measured by PI and/or Physical Therapy assessments and used to compare whether there is a difference in the participants range of motion between short- and long-term groups.
measure: Quality of Life - SF-12
time frame: This assessment will be collected at 2- and 6-week follow-up office visits.
description: Evaluate the patient quality of life through SF-12 assessment score to assess if there is a trending difference between short- and long-term groups.
measure: Quality of Life - EQ-5D-5L
time frame: This assessment will be collected at 2- and 6-week follow-up office visits.
description: Evaluate the patient quality of life through EQ-5D-5L assessment score to assess if there is a trending difference between short- and long-term groups.
measure: Number of Participants with Intraoperative Blood Loss (mL)
time frame: Conclusion of Surgery
description: Intraoperative blood loss in mL will be collected from patient records
measure: Hemoglobin Laboratory Results (grams/deciliter)
time frame: Hemoglobin and hematocrit laboratory results will be collected from the patient's pre-operative testing laboratory results (within 30 days before surgery) and from post-operative inpatient laboratory results (within 48 hours post-operative).
description: Hemoglobin levels will be collected from patient records
measure: Hematocrit Laboratory Results (Percentage of Concentration)
time frame: Hemoglobin and hematocrit laboratory results will be collected from the patient's pre-operative testing laboratory results (within 30 days before surgery) and from post-operative inpatient laboratory results (within 48 hours post-operative).
description: Hematocrit levels will be collected from patient records.
arm group label: Short-term ON-Q
arm group type: Active Comparator
description: Single port, select-a-flow pump and ON-Q 750mL ball filled with bupivacaine 0.125% saphenous (adductor canal) nerve block and single port, fixed flow pump and 400mL ON-Q ball with bupivacaine 0.125% wide field posterior knee block to provide analgesia from surgery until medication has been depleted (typically 2-4 days)
arm group label: Long-term ON-Q
arm group type: Experimental
description: Single port, select-a-flow pump and two 750mL ON-Q balls filled with bupivacaine 0.125% saphenous (adductor canal) nerve block and single port, fixed flow pump and two 400mL ON-Q ball with bupivacaine 0.125% wide field posterior knee block to provide analgesia from surgery up to 7 days post-operative. The second ball for each location will be provided pre-operatively, along with patient education for connection.
intervention type: Device
intervention name: Short-term ON-Q
description: single port, select-a-flow pump connected to saphenous nerve block catheter until medication in initial balls are depleted (usually 2-4 days)
arm group label: Short-term ON-Q
intervention type: Device
intervention name: Short-term ON-Q
description: single port, fixed flow pump connected to posterior knee catheter until medication in initial balls are depleted (usually 2-4 days)
arm group label: Short-term ON-Q
intervention type: Drug
intervention name: Short-term ON-Q
description: Bupivacaine 0.125%
arm group label: Short-term ON-Q
intervention type: Device
intervention name: Long-term ON-Q
description: single port, select-a-flow pump connected to saphenous nerve block catheter until day 7 post-operative
arm group label: Long-term ON-Q
intervention type: Device
intervention name: Long-term ON-Q
description: single port, fixed flow pump connected to posterior knee catheter until day 7 post-operative
arm group label: Long-term ON-Q
intervention type: Drug
intervention name: Long-term ON-Q
description: Bupivacaine 0.125%
arm group label: Long-term ON-Q
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: J. Dean Cole, M.D.
role: Principal Investigator
affiliation: AdventHealth
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: No