<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/NCT02242591</url>
  </required_header>
  <id_info>
    <org_study_id>2014-002245-21</org_study_id>
    <nct_id>NCT02242591</nct_id>
  </id_info>
  <brief_title>Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain After Total Knee Arthroplasty</brief_title>
  <official_title>Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain on the First Post-operative Day After Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ulrik Grevstad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Gentofte, Copenhagen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of adductor canal block (ACB) vs. placebo&#xD;
      on muscle strength, mobility and pain on the first postoperative day after total knee&#xD;
      alloplastic (TKA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be included on the first day after TKA surgery and randomized in two groups.&#xD;
      Each group will receive 2 ACB with a 1 hour interval, one ACB with an active drug,&#xD;
      Ropivacaine, and another ACB with a placebo drug, Saline.&#xD;
&#xD;
      At T0, arm ACB_active/placebo will receive the active ACB with Ropivacaine followed by the&#xD;
      placebo ACB at T60 (60 minutes after T0).&#xD;
&#xD;
      At T0, arm ACB_placebo/active will receive the placebo ACB with Saline followed by the active&#xD;
      ACB with Ropivacaine at T60 (60 minutes after T0).&#xD;
&#xD;
      Outcome measurements will be made at T60, 1 hour after the first ACB, and the difference in&#xD;
      outcome between the groups will be compared.&#xD;
&#xD;
      Baseline values will be measured prior to the first ACB. Final measurements at T120 (120&#xD;
      minutes after the initial ACB), will determine if the differences between the groups are&#xD;
      eliminated, since both groups then have received an active ACB.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between groups in muscle strength of the quadriceps femoris muscle.</measure>
    <time_frame>60 minutes after first ACB (T60)</time_frame>
    <description>Muscle strength is assessed as maximum voluntary isometric contraction (MVIC) using a hand-held dynamometer.3 consecutive measurements will be made and the average used. Results for each group will be presented as percentage of baseline values. The primary outcome is the difference in MVIC between the groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference between groups in muscle strength of the quadriceps femoris muscle.</measure>
    <time_frame>120 minutes after initial ACB (T120)</time_frame>
    <description>Same as primary outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS pain scores at rest</measure>
    <time_frame>60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)</time_frame>
    <description>Pain at rest (VAS 0-100 mm) one hour after the first and second ACB. Results will be compared between the two groups.&#xD;
VAS pain scores at rest will be inquired before any other outcome measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS pain score during TUG test.</measure>
    <time_frame>60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120</time_frame>
    <description>Highest VAS (0-100 mm) pain score during TUG test will be inquired for each TUG test. Results will be compared between the two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed Up and Go(TUG) test</measure>
    <time_frame>60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120</time_frame>
    <description>Time (seconds) to complete a TUG test measured one hour after the first and second ACB. Results will be compared between the two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS pain scores during 45 degrees active flexion of the knee</measure>
    <time_frame>60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120</time_frame>
    <description>Specification of pain (VAS 0-100 mm) during 45 degrees active flexion of the knee one hour after first and second ACB. Results will be compared between the two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sub-group analysis of muscle strength and mobility acconding to baseline VAS during active flexion of the knee prior to the first block</measure>
    <time_frame>60 minutes after first ACB (T60)</time_frame>
    <description>According to their specified VAS (0-100 mm) pain score during active flexion of the knee prior to the first block, patients will be divided into two groups. Group 1 VAS 0-59 mm and group 2 with VAS 60-100 mm. Results within the two groups will be compared: e.g is there a difference in MVIC in the subgroup of patients scoring VAS 0-59 during active knee flexion at baseline? and is this difference larger in the subgroup of patients scoring VAS 60-100?</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Knee Replacement Arthroplasty</condition>
  <arm_group>
    <arm_group_label>ACB_active/placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive the first ACB with a active drug, 30 ml bolus Ropivacaine 7,5 mg/ml at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60 (60 minutes after T0), patients will receive their second ACB with the placebo drug, 30 ml bolus Saline and outcome measures performed again at T120(120 minutes after T0).&#xD;
The measurements for baseline and outcome will be made in following order:&#xD;
VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACB_placebo/active</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive the first ACB with placebo, 30 ml isotonic saline at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60(60 minutes after T0), patients will receive their second ACB with the ropivacaine 7,5 mg/ml 30 ml and outcome measures performed again at T120(120 minutes after T0).&#xD;
The measurements for baseline and outcome will be made in following order:&#xD;
VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine 7,5 mg/ml</intervention_name>
    <arm_group_label>ACB_active/placebo</arm_group_label>
    <arm_group_label>ACB_placebo/active</arm_group_label>
    <other_name>Product name: Ropivacain &quot;Fresenius Kabi&quot;</other_name>
    <other_name>Ropivacainhydrochloridmonohydrat</other_name>
    <other_name>Importet to Denmark by Fresenius Kabi AB</other_name>
    <other_name>Injection mixture</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <arm_group_label>ACB_active/placebo</arm_group_label>
    <arm_group_label>ACB_placebo/active</arm_group_label>
    <other_name>Product name: Natriumklorid &quot;Fresenius Kabi&quot; 9 mg/ml</other_name>
    <other_name>Sodium 9g/l</other_name>
    <other_name>Electrolyte content: Na+ 154 mmol/l</other_name>
    <other_name>Cl- 154 mmol/l</other_name>
    <other_name>Infusion mixture</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have had a Total Knee Arthroplasty surgery within 2 days (1.postoperative&#xD;
             day on inclusion)&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
          -  ASA 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-cooperative patients&#xD;
&#xD;
          -  Patients who have already had a peripheral or central block post surgery.&#xD;
&#xD;
          -  Patients who are not able to perform a TUG test pre surgery.&#xD;
&#xD;
          -  Patients who do not understand or speak Danish.&#xD;
&#xD;
          -  Patient who are allergic to the drugs used in this research.&#xD;
&#xD;
          -  Patients with alcohol- or drug abuse - determined by investigator.&#xD;
&#xD;
          -  Patients with peripheral sensory neuropathy in their lower extremities.&#xD;
&#xD;
          -  Pregnant patients.&#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>Ulrik Grevstad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gentofte Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gentofte Hospital</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>November 26, 2014</last_update_submitted>
  <last_update_submitted_qc>November 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Gentofte, Copenhagen</investigator_affiliation>
    <investigator_full_name>Ulrik Grevstad</investigator_full_name>
    <investigator_title>Consultant, MD</investigator_title>
  </responsible_party>
  <keyword>Knee surgery</keyword>
  <keyword>Saphenous nerve</keyword>
  <keyword>Perineural block</keyword>
  <keyword>Adductor Canal Block</keyword>
  <keyword>Postoperative Pain</keyword>
  <keyword>Mobilization</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</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/NCT02242591
org study id: 2014-002245-21
nct id: NCT02242591
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the effect of adductor canal block (ACB) vs. placebo
      on muscle strength, mobility and pain on the first postoperative day after total knee
      alloplastic (TKA).
Patients will be included on the first day after TKA surgery and randomized in two groups.
      Each group will receive 2 ACB with a 1 hour interval, one ACB with an active drug,
      Ropivacaine, and another ACB with a placebo drug, Saline.

      At T0, arm ACB_active/placebo will receive the active ACB with Ropivacaine followed by the
      placebo ACB at T60 (60 minutes after T0).

      At T0, arm ACB_placebo/active will receive the placebo ACB with Saline followed by the active
      ACB with Ropivacaine at T60 (60 minutes after T0).

      Outcome measurements will be made at T60, 1 hour after the first ACB, and the difference in
      outcome between the groups will be compared.

      Baseline values will be measured prior to the first ACB. Final measurements at T120 (120
      minutes after the initial ACB), will determine if the differences between the groups are
      eliminated, since both groups then have received an active ACB.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Difference between groups in muscle strength of the quadriceps femoris muscle.
time frame: 60 minutes after first ACB (T60)
description: Muscle strength is assessed as maximum voluntary isometric contraction (MVIC) using a hand-held dynamometer.3 consecutive measurements will be made and the average used. Results for each group will be presented as percentage of baseline values. The primary outcome is the difference in MVIC between the groups.
measure: Difference between groups in muscle strength of the quadriceps femoris muscle.
time frame: 120 minutes after initial ACB (T120)
description: Same as primary outcome
measure: VAS pain scores at rest
time frame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)
description: Pain at rest (VAS 0-100 mm) one hour after the first and second ACB. Results will be compared between the two groups.
VAS pain scores at rest will be inquired before any other outcome measurements.
measure: VAS pain score during TUG test.
time frame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
description: Highest VAS (0-100 mm) pain score during TUG test will be inquired for each TUG test. Results will be compared between the two groups.
measure: Timed Up and Go(TUG) test
time frame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
description: Time (seconds) to complete a TUG test measured one hour after the first and second ACB. Results will be compared between the two groups.
measure: VAS pain scores during 45 degrees active flexion of the knee
time frame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
description: Specification of pain (VAS 0-100 mm) during 45 degrees active flexion of the knee one hour after first and second ACB. Results will be compared between the two groups.
measure: Sub-group analysis of muscle strength and mobility acconding to baseline VAS during active flexion of the knee prior to the first block
time frame: 60 minutes after first ACB (T60)
description: According to their specified VAS (0-100 mm) pain score during active flexion of the knee prior to the first block, patients will be divided into two groups. Group 1 VAS 0-59 mm and group 2 with VAS 60-100 mm. Results within the two groups will be compared: e.g is there a difference in MVIC in the subgroup of patients scoring VAS 0-59 during active knee flexion at baseline? and is this difference larger in the subgroup of patients scoring VAS 60-100?
arm group label: ACB_active/placebo
arm group type: Active Comparator
description: Patients will receive the first ACB with a active drug, 30 ml bolus Ropivacaine 7,5 mg/ml at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60 (60 minutes after T0), patients will receive their second ACB with the placebo drug, 30 ml bolus Saline and outcome measures performed again at T120(120 minutes after T0).
The measurements for baseline and outcome will be made in following order:
VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test
arm group label: ACB_placebo/active
arm group type: Placebo Comparator
description: Patients will receive the first ACB with placebo, 30 ml isotonic saline at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60(60 minutes after T0), patients will receive their second ACB with the ropivacaine 7,5 mg/ml 30 ml and outcome measures performed again at T120(120 minutes after T0).
The measurements for baseline and outcome will be made in following order:
VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test
intervention type: Drug
intervention name: Ropivacaine 7,5 mg/ml
arm group label: ACB_active/placebo
arm group label: ACB_placebo/active
other name: Product name: Ropivacain "Fresenius Kabi"
other name: Ropivacainhydrochloridmonohydrat
other name: Importet to Denmark by Fresenius Kabi AB
other name: Injection mixture
intervention type: Drug
intervention name: Saline
arm group label: ACB_active/placebo
arm group label: ACB_placebo/active
other name: Product name: Natriumklorid "Fresenius Kabi" 9 mg/ml
other name: Sodium 9g/l
other name: Electrolyte content: Na+ 154 mmol/l
other name: Cl- 154 mmol/l
other name: Infusion mixture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Ulrik Grevstad, MD
role: Principal Investigator
affiliation: Gentofte Hospital
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Gentofte, Copenhagen
investigator full name: Ulrik Grevstad
investigator title: Consultant, MD
mesh term: Ropivacaine