<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/NCT02249481</url>
  </required_header>
  <id_info>
    <org_study_id>14/P/132</org_study_id>
    <nct_id>NCT02249481</nct_id>
  </id_info>
  <brief_title>A Comparison of Anaesthetic Methods for Total Knee Replacement Surgery</brief_title>
  <official_title>A Comparison of Continuous Adductor Canal Catheter Infusion vs Continuous Femoral Nerve Catheter Infusion for Total Knee Replacement Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Plymouth NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Plymouth NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Open-labelled, randomised controlled trial. Patients will be assessed pre-operatively, at 24&#xD;
      and 48 hours for the primary outcome and secondary outcomes (except for Oxford Knee Score&#xD;
      which will be assessed pre-operatively and at 6 months post-operatively by the ortho-paedic&#xD;
      team).&#xD;
&#xD;
      Primary Objective: To demonstrate whether adductor canal nerve infusions result in superior&#xD;
      patient mobilisation within the first 48 hours following total knee replacement compared to&#xD;
      femoral nerve catheter infusions.&#xD;
&#xD;
      Secondary Objective: To identify whether adductor canal nerve infusions result in superior&#xD;
      analgesia within the first 48 hours following total knee replacement compared to femoral&#xD;
      nerve catheter infusions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We are comparing a continuous adductor canal block with a low concentration continuous&#xD;
      femoral nerve block. We currently use a low dose femoral nerve catheter based technique as&#xD;
      part of our standard treatment strategy for total knee arthroplasty. The use of a catheter&#xD;
      provides prolonged analgesia compared to a single shot block, and also allows a lower&#xD;
      concentration of local anaesthetic to be employed, thus potentially reducing the incidence of&#xD;
      motor blockade. The concentration of local anaesthetic employed in our routine practice&#xD;
      (0.0625% L- Bupivacaine) is lower than that routinely used in many other centres, and most&#xD;
      clinical studies have compared higher concentrations of local anaesthetic - this might be&#xD;
      expected to produce more motor blockade. The concentration we use is higher than the minimum&#xD;
      effective concentration for a femoral catheter infusion for knee arthroplasty.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    A number of issues which impact on the ability to recruit patients to the study&#xD;
  </why_stopped>
  <start_date type="Actual">December 8, 2015</start_date>
  <completion_date type="Actual">June 27, 2017</completion_date>
  <primary_completion_date type="Actual">June 27, 2017</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>Timed Up Go (TUG) test</measure>
    <time_frame>24 hours post-op</time_frame>
    <description>This measures the time (in seconds) taken by a patient to rise to their feet from a sitting position, walk 3 metres in a straight line, turn around, walk back to the seat and sit down again.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed Up Go (TUG) test</measure>
    <time_frame>48 hours post-op</time_frame>
    <description>This measures the time (in seconds) taken by a patient to rise to their feet from a sitting position, walk 3 metres in a straight line, turn around, walk back to the seat and sit down again.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total opiate consumption</measure>
    <time_frame>48 hours post-op</time_frame>
    <description>morphine equivalence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Score (VAS) for pain</measure>
    <time_frame>24 and 48 hours post-op</time_frame>
    <description>Both at rest and on active movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of knee flexion</measure>
    <time_frame>24 and 48 hours post-op</time_frame>
    <description>The range of flexion movement (in degrees) is recorded using a goniometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Voluntary Isometric Contraction (MVIC)</measure>
    <time_frame>24 and 48 hours post-op</time_frame>
    <description>The quadriceps muscle power in the operative leg is assessed using a handheld dynamometer (HHD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxford Knee Score (OKS)</measure>
    <time_frame>Pre-op, and at 6 months post-op</time_frame>
    <description>Patient reported outcome score.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Total Knee Replacement</condition>
  <arm_group>
    <arm_group_label>Group F</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Femoral nerve catheter delivering 0.0625% L- Bupivacaine: Blockade at level of Femoral crease. Identify femoral nerve. In plane lateral approach. Bolus 20 mls via needle. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad).and 5 mls injected via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adductor canal catheter delivering 0.0625% L- Bupivacaine: Blockade at mid-thigh. Identify sartorius at mid thigh - find point where the femoral artery begins to descend from sartorius. In plane technique, hydro-dissect space between sartorius and femoral artery. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad). Bolus 20 mls via needle and 5 mls via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Adductor Canal catheter delivering 0.0625% L- Bupivacaine</intervention_name>
    <description>Adductor canal catheter: Blockade at mid-thigh. Identify sartorius at mid thigh - find point where the femoral artery begins to descend from sartorius. In plane technique, hydro-dissect space between sartorius and femoral artery. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad). Bolus 20 mls via needle and 5 mls via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.</description>
    <arm_group_label>Group A</arm_group_label>
    <other_name>Adductor Canal Block (0.0625% L- Bupivacaine)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Femoral nerve catheter delivering 0.0625% L- Bupivacaine</intervention_name>
    <description>Femoral nerve catheter: Blockade at level of Femoral crease. Identify femoral nerve. In plane lateral approach. Bolus 20 mls via needle. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad).and 5 mls injected via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.</description>
    <arm_group_label>Group F</arm_group_label>
    <other_name>Femoral nerve Block (0.0625% L- Bupivacaine)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has a diagnosis of rheumatoid or osteoarthritis and listed for a primary total&#xD;
             knee replacement.&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
          -  Male or Female, aged between 18 and 85 years.&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) score I-III&#xD;
&#xD;
          -  Able (in the clinical staff's opinion) and willing to comply with all study&#xD;
             requirements.&#xD;
&#xD;
          -  Willing to allow his or her General Practitioner and consultant, if appropriate, to be&#xD;
             noti-fied of participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Chronic pain (defined as consumption of &gt;480mg codeine/24hrs or ANY regular strong&#xD;
             opiate consumption by the oral/transdermal route)&#xD;
&#xD;
          -  Patients aged &lt;18 or &gt;85&#xD;
&#xD;
          -  ASA score &gt;III&#xD;
&#xD;
          -  Body mass index (BMI) &gt;35&#xD;
&#xD;
          -  Lacking mental capacity to give consent to enter trial/undergo surgery&#xD;
&#xD;
          -  Contraindications to catheter placement (coagulopathy , systemic sepsis or infection&#xD;
             at placement site, pre-existing neuropathy) or any other component to the study&#xD;
             treatment pathway.&#xD;
&#xD;
          -  Participant who is terminally ill&#xD;
&#xD;
          -  Allergy/intolerance to study medications&#xD;
&#xD;
          -  Any other significant disease or disorder which, in the opinion of the Investigator,&#xD;
             may either put the participants at risk because of participation in the study, or may&#xD;
             influence the result of the study, or the participant's ability to participate in the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matt Oldman, MB BS, FRCA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Plymouth NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Plymouth Hospitals NHS Trust</name>
      <address>
        <city>Plymouth</city>
        <state>Devon</state>
        <zip>PL6 8BQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 3, 2019</last_update_submitted>
  <last_update_submitted_qc>September 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anaesthetic</keyword>
  <keyword>total knee replacement</keyword>
  <keyword>Femoral nerve catheter</keyword>
  <keyword>Adductor canal catheter</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02249481
org study id: 14/P/132
nct id: NCT02249481
lead sponsor: 
has dmc: No
Open-labelled, randomised controlled trial. Patients will be assessed pre-operatively, at 24
      and 48 hours for the primary outcome and secondary outcomes (except for Oxford Knee Score
      which will be assessed pre-operatively and at 6 months post-operatively by the ortho-paedic
      team).

      Primary Objective: To demonstrate whether adductor canal nerve infusions result in superior
      patient mobilisation within the first 48 hours following total knee replacement compared to
      femoral nerve catheter infusions.

      Secondary Objective: To identify whether adductor canal nerve infusions result in superior
      analgesia within the first 48 hours following total knee replacement compared to femoral
      nerve catheter infusions.
We are comparing a continuous adductor canal block with a low concentration continuous
      femoral nerve block. We currently use a low dose femoral nerve catheter based technique as
      part of our standard treatment strategy for total knee arthroplasty. The use of a catheter
      provides prolonged analgesia compared to a single shot block, and also allows a lower
      concentration of local anaesthetic to be employed, thus potentially reducing the incidence of
      motor blockade. The concentration of local anaesthetic employed in our routine practice
      (0.0625% L- Bupivacaine) is lower than that routinely used in many other centres, and most
      clinical studies have compared higher concentrations of local anaesthetic - this might be
      expected to produce more motor blockade. The concentration we use is higher than the minimum
      effective concentration for a femoral catheter infusion for knee arthroplasty.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Timed Up Go (TUG) test
time frame: 24 hours post-op
description: This measures the time (in seconds) taken by a patient to rise to their feet from a sitting position, walk 3 metres in a straight line, turn around, walk back to the seat and sit down again.
measure: Timed Up Go (TUG) test
time frame: 48 hours post-op
description: This measures the time (in seconds) taken by a patient to rise to their feet from a sitting position, walk 3 metres in a straight line, turn around, walk back to the seat and sit down again.
measure: Total opiate consumption
time frame: 48 hours post-op
description: morphine equivalence
measure: Visual Analogue Score (VAS) for pain
time frame: 24 and 48 hours post-op
description: Both at rest and on active movement
measure: Range of knee flexion
time frame: 24 and 48 hours post-op
description: The range of flexion movement (in degrees) is recorded using a goniometer
measure: Maximum Voluntary Isometric Contraction (MVIC)
time frame: 24 and 48 hours post-op
description: The quadriceps muscle power in the operative leg is assessed using a handheld dynamometer (HHD)
measure: Oxford Knee Score (OKS)
time frame: Pre-op, and at 6 months post-op
description: Patient reported outcome score.
arm group label: Group F
arm group type: Active Comparator
description: Femoral nerve catheter delivering 0.0625% L- Bupivacaine: Blockade at level of Femoral crease. Identify femoral nerve. In plane lateral approach. Bolus 20 mls via needle. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad).and 5 mls injected via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.
arm group label: Group A
arm group type: Experimental
description: Adductor canal catheter delivering 0.0625% L- Bupivacaine: Blockade at mid-thigh. Identify sartorius at mid thigh - find point where the femoral artery begins to descend from sartorius. In plane technique, hydro-dissect space between sartorius and femoral artery. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad). Bolus 20 mls via needle and 5 mls via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.
intervention type: Procedure
intervention name: Adductor Canal catheter delivering 0.0625% L- Bupivacaine
description: Adductor canal catheter: Blockade at mid-thigh. Identify sartorius at mid thigh - find point where the femoral artery begins to descend from sartorius. In plane technique, hydro-dissect space between sartorius and femoral artery. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad). Bolus 20 mls via needle and 5 mls via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.
arm group label: Group A
other name: Adductor Canal Block (0.0625% L- Bupivacaine)
intervention type: Procedure
intervention name: Femoral nerve catheter delivering 0.0625% L- Bupivacaine
description: Femoral nerve catheter: Blockade at level of Femoral crease. Identify femoral nerve. In plane lateral approach. Bolus 20 mls via needle. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad).and 5 mls injected via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.
arm group label: Group F
other name: Femoral nerve Block (0.0625% L- Bupivacaine)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Matt Oldman, MB BS, FRCA
role: Principal Investigator
affiliation: University Hospital Plymouth NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Bupivacaine