<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/NCT02991404</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00041950</org_study_id>
    <nct_id>NCT02991404</nct_id>
  </id_info>
  <brief_title>Single Injection Adductor Canal Block Versus Continuous Adductor Canal Infusion for Total Knee Arthroplasty</brief_title>
  <official_title>Single Injection Adductor Canal Block Versus Continuous Adductor Canal Infusion for Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients undergoing Primary Total Knee Arthroplasty will be randomized to receive either&#xD;
      multimodal single injection adductor canal block with sham infusion catheter or continuous&#xD;
      infusion of local anesthetic (control) for postoperative analgesia.&#xD;
&#xD;
      Primary end point is pain scores at 30 hours post performance of block procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to determine if a single shot multimodal peripheral nerve&#xD;
      block containing bupivacaine, dexamethasone, buprenorphine, clonidine, and epinephrine will&#xD;
      provide comparable (equivalent) analgesic control when compared to an adductor catheter. The&#xD;
      primary end point will be pain scores at 30 hours post block initiation. Secondary end points&#xD;
      will include, opioid consumption, time to first analgesic request; pain scores; binary&#xD;
      patient satisfaction (yes/no); likeliness to recommend their analgesic regimen, straight leg&#xD;
      raise test on post-operative day (POD) number 1; adverse events, incidence of post-operative&#xD;
      nausea, and vomiting.&#xD;
&#xD;
      Methods and Measures Design The study will be a randomized, double-blind, sham catheter&#xD;
      study. Patients will be recruited and randomized to one of two groups: The &quot;Treatment Arm&quot;&#xD;
      receive a single shot adductor canal block containing 20 milliliters (ml) of solution&#xD;
      including 0.25% bupivacaine, 150 mcg of buprenorphine, 2 mg of dexamethasone, 1.67 mcg/ml of&#xD;
      clonidine, and 1:400,000 epinephrine with sham catheter. The sham catheter will be placed in&#xD;
      the Sartorius muscle in the same sterile, aseptic fashion as patient's in the control arm.&#xD;
      The pump will be set at the lowest possible volume per hour of normal saline (0.1 ml/hour in&#xD;
      the current pump in use at our hospital). An opaque bag will be placed over the pump for&#xD;
      blinding purposes. The &quot;Control Arm&quot; will receive an adductor canal catheter through which&#xD;
      they will receive a 20 ml bolus of 0.25% bupivacaine with 1:400,000 epinephrine followed by&#xD;
      an adductor canal catheter infusion of 0.125% bupivacaine at 10 ml/hour. An opaque bag will&#xD;
      be placed over the control arm pumps in similar fashion. For all patients, the order in the&#xD;
      electronic medical record will be per research pharmacy protocol. For their primary&#xD;
      anesthetic, patients in both arms will then receive either a subarachnoid (spinal) anesthetic&#xD;
      or general anesthetic per the anesthesiologist in the operating room.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 17, 2017</start_date>
  <completion_date type="Actual">November 15, 2017</completion_date>
  <primary_completion_date type="Actual">November 15, 2017</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain scores</measure>
    <time_frame>30 hours post block placement</time_frame>
    <description>At 30 hours pain scores between the two groups will be compared for determining statistically significant differences</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>total opioid consumption</measure>
    <time_frame>Through 30 hours post block</time_frame>
    <description>The amount of total opioid consumed will be collected</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <condition>Pain, Postoperative</condition>
  <condition>Adductor Canal Block</condition>
  <arm_group>
    <arm_group_label>Continuous adductor canal block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time (Initial bolus) 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour.&#xD;
Multimodal peripheral nerve block injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single injection block with sham cath</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Single Shot Adductor Canal Block . Patients will receive single injection adductor canal block (Initial Bolus) with bupivacaine 0.25%, epinephrine, clonidine, buprenorphine and dexamethasone. These patients will have a sham infusion catheter of inert saline placed in the same fashion as the other group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Multimodal Peripheral Nerve Block Injection</intervention_name>
    <description>After successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour.</description>
    <arm_group_label>Continuous adductor canal block</arm_group_label>
    <other_name>adductor canal catheter bolus and continuous infusion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Single Shot Adductor Canal Block</intervention_name>
    <description>A total of 20 ml of solution containing a combination of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, 150 micrograms of buprenorphine, 2 mg of dexamethasone, and 1:400,000 epinephrine will be administered underneath the Sartorius muscle. A sham catheter will then be placed subcutaneously into the Sartorius muscle, secured in typical fashion, and connected to a pump containing saline to provide similar shape and weight with an opaque bag covering the pump. The pump will be run at the lowest possible ml/hour rate, which is currently 0.1 ml/hour with the current pump used in our hospital.</description>
    <arm_group_label>Single injection block with sham cath</arm_group_label>
    <other_name>adductor canal block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Initial Bolus</intervention_name>
    <description>20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine</description>
    <arm_group_label>Continuous adductor canal block</arm_group_label>
    <arm_group_label>Single injection block with sham cath</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Continuous infusion</intervention_name>
    <description>Continuous infusion of 0.125% bupivacaine</description>
    <arm_group_label>Continuous adductor canal block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients will be eligible for inclusion in the study if they are:&#xD;
&#xD;
          -  Age of 18 years old or older&#xD;
&#xD;
          -  Scheduled to primary unilateral total knee arthroplasty.&#xD;
&#xD;
          -  Patients must give written informed consent for anesthesia including continuous&#xD;
             adductor canal block for postoperative analgesia prior to recruitment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if they have:&#xD;
&#xD;
          -  A contraindication to an adductor canal block or catheter placement including, but not&#xD;
             limited to site infection, irritation, or refusal.&#xD;
&#xD;
          -  Poorly controlled diabetes (A1C &gt;8.0)&#xD;
&#xD;
          -  Allergy to medications involves in this study (opioids, bupivacaine, buprenorphine,&#xD;
             clonidine, or dexamethasone)&#xD;
&#xD;
          -  Opioid use &gt;40 mg of oxycodone daily, long-acting opioids.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan D Jaffe, D.O.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dr.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest Baptist Hospital</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>April 3, 2018</last_update_submitted>
  <last_update_submitted_qc>April 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT02991404
org study id: IRB00041950
nct id: NCT02991404
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Patients undergoing Primary Total Knee Arthroplasty will be randomized to receive either
      multimodal single injection adductor canal block with sham infusion catheter or continuous
      infusion of local anesthetic (control) for postoperative analgesia.

      Primary end point is pain scores at 30 hours post performance of block procedure.
The objective of this study is to determine if a single shot multimodal peripheral nerve
      block containing bupivacaine, dexamethasone, buprenorphine, clonidine, and epinephrine will
      provide comparable (equivalent) analgesic control when compared to an adductor catheter. The
      primary end point will be pain scores at 30 hours post block initiation. Secondary end points
      will include, opioid consumption, time to first analgesic request; pain scores; binary
      patient satisfaction (yes/no); likeliness to recommend their analgesic regimen, straight leg
      raise test on post-operative day (POD) number 1; adverse events, incidence of post-operative
      nausea, and vomiting.

      Methods and Measures Design The study will be a randomized, double-blind, sham catheter
      study. Patients will be recruited and randomized to one of two groups: The "Treatment Arm"
      receive a single shot adductor canal block containing 20 milliliters (ml) of solution
      including 0.25% bupivacaine, 150 mcg of buprenorphine, 2 mg of dexamethasone, 1.67 mcg/ml of
      clonidine, and 1:400,000 epinephrine with sham catheter. The sham catheter will be placed in
      the Sartorius muscle in the same sterile, aseptic fashion as patient's in the control arm.
      The pump will be set at the lowest possible volume per hour of normal saline (0.1 ml/hour in
      the current pump in use at our hospital). An opaque bag will be placed over the pump for
      blinding purposes. The "Control Arm" will receive an adductor canal catheter through which
      they will receive a 20 ml bolus of 0.25% bupivacaine with 1:400,000 epinephrine followed by
      an adductor canal catheter infusion of 0.125% bupivacaine at 10 ml/hour. An opaque bag will
      be placed over the control arm pumps in similar fashion. For all patients, the order in the
      electronic medical record will be per research pharmacy protocol. For their primary
      anesthetic, patients in both arms will then receive either a subarachnoid (spinal) anesthetic
      or general anesthetic per the anesthesiologist in the operating room.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Pain scores
time frame: 30 hours post block placement
description: At 30 hours pain scores between the two groups will be compared for determining statistically significant differences
measure: total opioid consumption
time frame: Through 30 hours post block
description: The amount of total opioid consumed will be collected
arm group label: Continuous adductor canal block
arm group type: Active Comparator
description: After successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time (Initial bolus) 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour.
Multimodal peripheral nerve block injection.
arm group label: Single injection block with sham cath
arm group type: Sham Comparator
description: Single Shot Adductor Canal Block . Patients will receive single injection adductor canal block (Initial Bolus) with bupivacaine 0.25%, epinephrine, clonidine, buprenorphine and dexamethasone. These patients will have a sham infusion catheter of inert saline placed in the same fashion as the other group.
intervention type: Procedure
intervention name: Multimodal Peripheral Nerve Block Injection
description: After successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour.
arm group label: Continuous adductor canal block
other name: adductor canal catheter bolus and continuous infusion
intervention type: Procedure
intervention name: Single Shot Adductor Canal Block
description: A total of 20 ml of solution containing a combination of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, 150 micrograms of buprenorphine, 2 mg of dexamethasone, and 1:400,000 epinephrine will be administered underneath the Sartorius muscle. A sham catheter will then be placed subcutaneously into the Sartorius muscle, secured in typical fashion, and connected to a pump containing saline to provide similar shape and weight with an opaque bag covering the pump. The pump will be run at the lowest possible ml/hour rate, which is currently 0.1 ml/hour with the current pump used in our hospital.
arm group label: Single injection block with sham cath
other name: adductor canal block
intervention type: Drug
intervention name: Initial Bolus
description: 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine
arm group label: Continuous adductor canal block
arm group label: Single injection block with sham cath
intervention type: Drug
intervention name: Continuous infusion
description: Continuous infusion of 0.125% bupivacaine
arm group label: Continuous adductor canal block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jonathan D Jaffe, D.O.
role: Principal Investigator
affiliation: Dr.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: No