<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/NCT01726686</url>
  </required_header>
  <id_info>
    <org_study_id>LIA-Pump_AA</org_study_id>
    <nct_id>NCT01726686</nct_id>
  </id_info>
  <brief_title>Pain Treatment After TKA With LIA and Intra-articular Continuous Infusion Pump</brief_title>
  <official_title>Evaluation of Intra-articular Continuous Infusion Pump With Ropivacaine in Addition to Local Infiltration Analgesia (LIA) in Total Knee Arthroplasty (TKA). A Placebo Controlled Randomised Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Skane</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect on postoperative pain and function by&#xD;
      adding intraarticular continuous infusion pump with local anesthetic after total knee&#xD;
      arthroplasty where local infiltration analgesia has already been given.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      200 patients with osteoarthritis (OA) of the knee necessitating total knee arthroplasty are&#xD;
      entered into the study. All patients are given a standard protocol of analgesics pre- and&#xD;
      postoperatively. All patients get periarticular LIA-injection (150 ml) with a total of 300 mg&#xD;
      Ropivacaine, 30 mg Toradol and 0.5 mg Adrenalin. In the end of the operation all patients get&#xD;
      an epidural type of catheter intraarticular with a coupled continuous infusion pump that&#xD;
      delivers 2 ml per hour and are disconnected after 48 hours. The University hospital pharmacy&#xD;
      has prepared 200 pumps; 100 Active substance pumps with 100 ml Ropivacaine (10mg/ml) and 100&#xD;
      placebo pumps with 100 ml sodium chloride (NaCl). All patients are by computer software&#xD;
      randomized to receive either active or placebo pump. Only one nurse, not involved in neither&#xD;
      the operation nor the after treatment, has the key to what substance it is in the numbered&#xD;
      pumps. Thus, it is a double blinded trial during the whole follow up period. Before the&#xD;
      operation the patients are asked to fill out a knee specific outcome questionnaire, the Knee&#xD;
      injury and Osteoarthritis Outcome Score (KOOS), and a general outcome questionnaire, the&#xD;
      Euroqol (EQ-5D), and the knee range of motion is measured by a physiotherapist. After the&#xD;
      operation the patients are monitored at the ward by the nurses and physiotherapists. The&#xD;
      level of pain is measured twice daily (noon and 8 PM) according to the Visual-Analog-Scale&#xD;
      (VAS). The range of motion and is measured on day 4 and at the day 14 and day 30 follow up.&#xD;
      The number of days the patients need to stay in hospital after operation are registered. The&#xD;
      amount of extra doses of analgesics the patient requires are registered as well as the&#xD;
      complications (illness, wound problems, infections etc). The patients are to be followed&#xD;
      clinically for 2 years as well as with outcome questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2010</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">July 2011</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>Change in postoperative pain</measure>
    <time_frame>The first 4 postoperative days at noon and 8 PM</time_frame>
    <description>The patient are asked to grade their pain on a VAS-scale (0-100)twice daily for the first 4 days after the TKA operation and at the 2 weeks follow-up. Changes in pain during this time frame are recorded to see if there are any differences between the two groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Extra oral analgesia consumption</measure>
    <time_frame>First 4 postoperative days</time_frame>
    <description>All extra analgesia consumption are noted during the first 4 postoperative days. All patients have a standard pain management medication (depending on weight, age and sex) and only extra doses are noted.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of postoperative days in hospital</measure>
    <time_frame>Duration of hospital stay, an expected time frame of 4-5 days</time_frame>
    <description>The number of days the patient needs to stay in hospital after operation are noted</description>
  </other_outcome>
  <other_outcome>
    <measure>Pre- and postoperative knee range of motion</measure>
    <time_frame>At preoperative admission for operation (about 2 weeks prior), day 4, 14 and 30 postoperatively</time_frame>
    <description>The range of motion in the affected knee are registered with a goniometer at the preoperative admission for operation, about 2 weeks prior to the operation and then on day 4, 14 and 30 postoperatively.</description>
  </other_outcome>
  <other_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>All complications postoperatively are registered for the first 2 years.</description>
  </other_outcome>
  <other_outcome>
    <measure>Knee specific and general questionaire</measure>
    <time_frame>preoperatively (about 2 weeks prior to op), 1 and 2 years postoperatively</time_frame>
    <description>The patients are asked to fill out the general health questionaire EQ-5D as well as the knee specific questionaire KOOS preoperatively at the admission for surgery (about 2 weeks before the operation) and at 1 and 2 year follow up.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Postoperative Pain Management</condition>
  <arm_group>
    <arm_group_label>Ropivacaine in the pump</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intra-articular Continuous Infusion Pump is filled with Ropivacaine,10 mg/ml, set at 2 ml/hour for 48 hours postoperatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo in the pump</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The intra-articular Continuous Infusion Pump is filled with NaCl, set at 2 ml/hour for 48 hours postoperatively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>100 ml Ropivacaine 10mg/ml in a continuous infusion pump set at 2 ml/hour</description>
    <arm_group_label>Ropivacaine in the pump</arm_group_label>
    <other_name>Naropin, Narop</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo in the pump</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary osteoarthritis of the knee necessitating total knee replacement&#xD;
&#xD;
          -  Patients who understand the conditions of the study and are willing to participate for&#xD;
             the length of the prescribed follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to local anaesthetics or other contraindication for the use of local&#xD;
             anaesthetics.&#xD;
&#xD;
          -  Treatment with Warfarin.&#xD;
&#xD;
          -  Bilateral operation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gunnar Flivik, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept of Orthopedics, Skane University Hospital, Lund University, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Orthopedics, Skane University Hospital, Lund University</name>
      <address>
        <city>Lund</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>November 24, 2014</last_update_submitted>
  <last_update_submitted_qc>November 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Skane</investigator_affiliation>
    <investigator_full_name>Gunnar Flivik</investigator_full_name>
    <investigator_title>Associate Professor, MD PhD</investigator_title>
  </responsible_party>
  <keyword>Total Knee Arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <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/NCT01726686
org study id: LIA-Pump_AA
nct id: NCT01726686
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effect on postoperative pain and function by
      adding intraarticular continuous infusion pump with local anesthetic after total knee
      arthroplasty where local infiltration analgesia has already been given.
200 patients with osteoarthritis (OA) of the knee necessitating total knee arthroplasty are
      entered into the study. All patients are given a standard protocol of analgesics pre- and
      postoperatively. All patients get periarticular LIA-injection (150 ml) with a total of 300 mg
      Ropivacaine, 30 mg Toradol and 0.5 mg Adrenalin. In the end of the operation all patients get
      an epidural type of catheter intraarticular with a coupled continuous infusion pump that
      delivers 2 ml per hour and are disconnected after 48 hours. The University hospital pharmacy
      has prepared 200 pumps; 100 Active substance pumps with 100 ml Ropivacaine (10mg/ml) and 100
      placebo pumps with 100 ml sodium chloride (NaCl). All patients are by computer software
      randomized to receive either active or placebo pump. Only one nurse, not involved in neither
      the operation nor the after treatment, has the key to what substance it is in the numbered
      pumps. Thus, it is a double blinded trial during the whole follow up period. Before the
      operation the patients are asked to fill out a knee specific outcome questionnaire, the Knee
      injury and Osteoarthritis Outcome Score (KOOS), and a general outcome questionnaire, the
      Euroqol (EQ-5D), and the knee range of motion is measured by a physiotherapist. After the
      operation the patients are monitored at the ward by the nurses and physiotherapists. The
      level of pain is measured twice daily (noon and 8 PM) according to the Visual-Analog-Scale
      (VAS). The range of motion and is measured on day 4 and at the day 14 and day 30 follow up.
      The number of days the patients need to stay in hospital after operation are registered. The
      amount of extra doses of analgesics the patient requires are registered as well as the
      complications (illness, wound problems, infections etc). The patients are to be followed
      clinically for 2 years as well as with outcome questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in postoperative pain
time frame: The first 4 postoperative days at noon and 8 PM
description: The patient are asked to grade their pain on a VAS-scale (0-100)twice daily for the first 4 days after the TKA operation and at the 2 weeks follow-up. Changes in pain during this time frame are recorded to see if there are any differences between the two groups.
measure: Extra oral analgesia consumption
time frame: First 4 postoperative days
description: All extra analgesia consumption are noted during the first 4 postoperative days. All patients have a standard pain management medication (depending on weight, age and sex) and only extra doses are noted.
measure: Number of postoperative days in hospital
time frame: Duration of hospital stay, an expected time frame of 4-5 days
description: The number of days the patient needs to stay in hospital after operation are noted
measure: Pre- and postoperative knee range of motion
time frame: At preoperative admission for operation (about 2 weeks prior), day 4, 14 and 30 postoperatively
description: The range of motion in the affected knee are registered with a goniometer at the preoperative admission for operation, about 2 weeks prior to the operation and then on day 4, 14 and 30 postoperatively.
measure: Postoperative complications
time frame: 2 years postoperatively
description: All complications postoperatively are registered for the first 2 years.
measure: Knee specific and general questionaire
time frame: preoperatively (about 2 weeks prior to op), 1 and 2 years postoperatively
description: The patients are asked to fill out the general health questionaire EQ-5D as well as the knee specific questionaire KOOS preoperatively at the admission for surgery (about 2 weeks before the operation) and at 1 and 2 year follow up.
arm group label: Ropivacaine in the pump
arm group type: Active Comparator
description: The intra-articular Continuous Infusion Pump is filled with Ropivacaine,10 mg/ml, set at 2 ml/hour for 48 hours postoperatively.
arm group label: Placebo in the pump
arm group type: Placebo Comparator
description: The intra-articular Continuous Infusion Pump is filled with NaCl, set at 2 ml/hour for 48 hours postoperatively.
intervention type: Drug
intervention name: Ropivacaine
description: 100 ml Ropivacaine 10mg/ml in a continuous infusion pump set at 2 ml/hour
arm group label: Ropivacaine in the pump
other name: Naropin, Narop
intervention type: Drug
intervention name: Placebo
arm group label: Placebo in the pump
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Gunnar Flivik, MD PhD
role: Principal Investigator
affiliation: Dept of Orthopedics, Skane University Hospital, Lund University, Sweden
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Region Skane
investigator full name: Gunnar Flivik
investigator title: Associate Professor, MD PhD
mesh term: Pain, Postoperative
mesh term: Ropivacaine