<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/NCT02185924</url>
  </required_header>
  <id_info>
    <org_study_id>S-138/15-06-10</org_study_id>
    <nct_id>NCT02185924</nct_id>
  </id_info>
  <brief_title>Combination of Continuous Femoral Block and Intravenous Parecoxib For Postoperative Analgesia After Total Knee Arthroplasty</brief_title>
  <official_title>COMBINATION OF CONTINUOUS FEMORAL BLOCK AND INTRAVENOUS PARECOXIB FOR POSTOPERATIVE ANALGESIA AFTER TOTAL KNEE ARTHROPLASTY. A DOUBLE BLIND PROSPECTIVE STUDY.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asklepieion Voulas General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asklepieion Voulas General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Combination of continuous femoral block with parEcoxib vs placebo. Investigation of morphine&#xD;
      consumption, opioid sparing effects, VAS pain scores, haemodynamics, Anxierty scores,&#xD;
      transfusion requirements , Range of motion and rehabilitation parameters between two groups&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MORPHINE CONSUMPTION WITH PCA BETWEEN TWO GROUPS</measure>
    <time_frame>36/h POSTOPERATIVELY</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>VAS PAIN SCORES BETWEEN TWO GROUPS</measure>
    <time_frame>36/h POSTOPERATIVELY</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>HAEMODYNAMIC PARAMETERS BETWEEN TWO GROUPS</measure>
    <time_frame>During perioperative period</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ANXIETY LEVELS</measure>
    <time_frame>36 HOURS POSTOPERATIVELY</time_frame>
    <description>ANXIETY SCORES WERE QUANTIFIED USING THE SPIELBERG INVENTORY</description>
  </secondary_outcome>
  <other_outcome>
    <measure>RANGE OF MOTION, TRANSFUSION REQUIREMENTS, VAS SCORES POSTOPERATIVELY</measure>
    <time_frame>AFTER 36 HOURS POSTOPERATIVELY</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>MODIFIED BROMAGE SCALE</measure>
    <time_frame>36/h POSTOPEPATIVELY</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>POSTOPERATIVE ANALGESIA FOR TKA PARECOXIB/CFB</condition>
  <arm_group>
    <arm_group_label>CONTINUOUS FEMORAL BLOCK AND PARECOXIB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuous infusion of0,2% of ropivacaine at 10 ml/h and 2 mls (40 mg) of iv parecoxib</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTINUOUS FEMORAL BLOCK AND PLACEBO</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Continuous infusion of 0.2% ropivacaine at 10 ml/h and 2 mls of iv N/S0.9%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Parecoxib</intervention_name>
    <arm_group_label>CONTINUOUS FEMORAL BLOCK AND PARECOXIB</arm_group_label>
    <other_name>DYNASTAT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%</intervention_name>
    <arm_group_label>CONTINUOUS FEMORAL BLOCK AND PARECOXIB</arm_group_label>
    <arm_group_label>CONTINUOUS FEMORAL BLOCK AND PLACEBO</arm_group_label>
    <other_name>NAROPEINE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>N/S 0.9%</intervention_name>
    <arm_group_label>CONTINUOUS FEMORAL BLOCK AND PLACEBO</arm_group_label>
    <other_name>PLACEBO</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PATIENTS ASA I-II UNDERGOING TOTAL KNEE ATRTHROPLASTY&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria for both groups included:&#xD;
&#xD;
          -  Age younger than 40 years old or older than 80 years old&#xD;
&#xD;
          -  ASA &gt; III&#xD;
&#xD;
          -  Obesity (&gt;140 kg body weight)&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  History dependence on opioids&#xD;
&#xD;
          -  Contraindications for subarachnoid anesthesia or femoral block (coagulopathy, local&#xD;
             infection, pre-existing neurological problems, patient refusal)&#xD;
&#xD;
          -  Contraindications to the administration of parecoxib&#xD;
&#xD;
          -  Severe hepatic or renal disease (serum creatinine ≥ 1.7 mg/dl)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>DESPOINA SARRIDOU, SENIOR REGISTRAR</last_name>
    <role>Principal Investigator</role>
    <affiliation>SENIOR CLINICAL FELLOW THE ROYAL BROMPTON AND HAREFIELD TRUST, SENIOR REGISTRAR IN ANAESTHESIA ASKLEPEION VOULAS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anaesthesia Asklepeion Voulas General Hospital</name>
      <address>
        <city>Voula Athens</city>
        <zip>16673</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 7, 2014</last_update_submitted>
  <last_update_submitted_qc>July 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asklepieion Voulas General Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Despoina Sarridou</investigator_full_name>
    <investigator_title>ANAESTHESIOLOGIST</investigator_title>
  </responsible_party>
  <keyword>PARECOXIB</keyword>
  <keyword>CONTINUOUS FEMORAL BLOCK</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agnosia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parecoxib</mesh_term>
    <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/NCT02185924
org study id: S-138/15-06-10
nct id: NCT02185924
lead sponsor: 
has dmc: No
Combination of continuous femoral block with parEcoxib vs placebo. Investigation of morphine
      consumption, opioid sparing effects, VAS pain scores, haemodynamics, Anxierty scores,
      transfusion requirements , Range of motion and rehabilitation parameters between two groups
allocation: Randomized
intervention model: Parallel Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: MORPHINE CONSUMPTION WITH PCA BETWEEN TWO GROUPS
time frame: 36/h POSTOPERATIVELY
measure: VAS PAIN SCORES BETWEEN TWO GROUPS
time frame: 36/h POSTOPERATIVELY
measure: HAEMODYNAMIC PARAMETERS BETWEEN TWO GROUPS
time frame: During perioperative period
measure: ANXIETY LEVELS
time frame: 36 HOURS POSTOPERATIVELY
description: ANXIETY SCORES WERE QUANTIFIED USING THE SPIELBERG INVENTORY
measure: RANGE OF MOTION, TRANSFUSION REQUIREMENTS, VAS SCORES POSTOPERATIVELY
time frame: AFTER 36 HOURS POSTOPERATIVELY
measure: MODIFIED BROMAGE SCALE
time frame: 36/h POSTOPEPATIVELY
arm group label: CONTINUOUS FEMORAL BLOCK AND PARECOXIB
arm group type: Experimental
description: Continuous infusion of0,2% of ropivacaine at 10 ml/h and 2 mls (40 mg) of iv parecoxib
arm group label: CONTINUOUS FEMORAL BLOCK AND PLACEBO
arm group type: Placebo Comparator
description: Continuous infusion of 0.2% ropivacaine at 10 ml/h and 2 mls of iv N/S0.9%
intervention type: Drug
intervention name: Parecoxib
arm group label: CONTINUOUS FEMORAL BLOCK AND PARECOXIB
other name: DYNASTAT
intervention type: Drug
intervention name: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%
arm group label: CONTINUOUS FEMORAL BLOCK AND PARECOXIB
arm group label: CONTINUOUS FEMORAL BLOCK AND PLACEBO
other name: NAROPEINE
intervention type: Drug
intervention name: N/S 0.9%
arm group label: CONTINUOUS FEMORAL BLOCK AND PLACEBO
other name: PLACEBO
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: DESPOINA SARRIDOU, SENIOR REGISTRAR
role: Principal Investigator
affiliation: SENIOR CLINICAL FELLOW THE ROYAL BROMPTON AND HAREFIELD TRUST, SENIOR REGISTRAR IN ANAESTHESIA ASKLEPEION VOULAS
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Asklepieion Voulas General Hospital
investigator full name: Dr. Despoina Sarridou
investigator title: ANAESTHESIOLOGIST
mesh term: Agnosia
mesh term: Parecoxib
mesh term: Ropivacaine