xml: <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/NCT05994287</url>
    </required_header>
    <id_info>
      <org_study_id>2021-2</org_study_id>
      <nct_id>NCT05994287</nct_id>
    </id_info>
    <brief_title>Pain Treatment With Combinations of NSAIDs</brief_title>
    <official_title>Pain Treatment After Joint Surgery With a Combination of Aspirin, Ketorolac, and Celecoxib.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Federal State Budgetary Organization, Federal Center for Traumatology, Orthopedics and Arthroplasty</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The search for new safe and effective methods of pain relief after surgery on large joints is&#xD;
        still an urgent problem. The most optimal approach in the treatment of postoperative pain is&#xD;
        the use of multimodal analgesia with a different mechanism of action that act on various&#xD;
        mechanisms of pain and can include opioids, nonsteroidal anti-inflammatory drugs (NSAIDs),&#xD;
        acetaminophen, anticonvulsants, NMDA antagonists, alpha-2-agonists, and sodium and calcium&#xD;
        channel blocking agents, as well as local anesthetics. NSAIDs are the most popular and safe&#xD;
        means for pain relief. Therefore, a lot of efforts are aimed at increasing the effectiveness&#xD;
        of NSAIDs use. The aim of this study was to evaluate the effectiveness of simultaneously&#xD;
        administering two or three NSAIDs, compared to using only one NSAID, for pain relief after&#xD;
        surgery on large joints such as hip or knee arthroplasty.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Actual">January 1, 2023</completion_date>
    <primary_completion_date type="Actual">January 1, 2022</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Measuring postoperative pain using the visual analog scale for pain (VAS-P)</measure>
      <time_frame>5 days</time_frame>
      <description>The patients choose the score on the 10 cm line scale with (VAS-P) rage from 0 ('no pain') to 10 (severe pain).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Arachidonic acid-stimulated platelet tests</measure>
      <time_frame>5 days</time_frame>
      <description>Assessed by Multiplate ASPItest, Roche Diagnostics GmbH. The platelet aggregation expressed in arbitrary aggregation units (AU) multiplied by the recorded time in minutes (AU*min).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin</measure>
      <time_frame>5 days</time_frame>
      <description>Hemoglobin (HGB) level in g/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hematocrit</measure>
      <time_frame>5 days</time_frame>
      <description>Hematocrit level in %</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Erythrocytes</measure>
      <time_frame>5 days</time_frame>
      <description>Erythrocytes (RBC) number in 1 litter</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Platelets cells</measure>
      <time_frame>5 days</time_frame>
      <description>Platelets cells (PLT) number in 1 litter</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fibrinogen</measure>
      <time_frame>5 days</time_frame>
      <description>Fibrinogen level in g/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Partial thromboplastin time</measure>
      <time_frame>5 days</time_frame>
      <description>Partial thromboplastin time (PTT) in seconds</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prothrombin time</measure>
      <time_frame>5 days</time_frame>
      <description>Prothrombin time in %</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">105</enrollment>
    <condition>Postoperative Pain, Acute</condition>
    <arm_group>
      <arm_group_label>Drug: celecoxib</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The patients received celecoxib in a dose of 400 mg orally daily. The drug was prescribed from the second day of the operation for 5 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Drug: aspirin with ketorolac</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patients received aspirin in a dose of 100 mg and ketorolac 90 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Drug: ketorolac and celecoxib</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patients received ketorolac in a dose of 90 mg and celecoxib 400 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Drug: aspirin, ketorolac and celecoxib</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The patients received aspirin in a dose of 200 mg, ketorolac 90 mg, and celecoxib 400 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Aspirin</intervention_name>
      <description>The patients received aspirin in a dose of 100 mg orally daily.</description>
      <arm_group_label>Drug: aspirin with ketorolac</arm_group_label>
      <arm_group_label>Drug: aspirin, ketorolac and celecoxib</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ketorolac</intervention_name>
      <description>The patients received ketorolac in a dose of 90 mg mg orally daily.</description>
      <arm_group_label>Drug: aspirin with ketorolac</arm_group_label>
      <arm_group_label>Drug: aspirin, ketorolac and celecoxib</arm_group_label>
      <arm_group_label>Drug: ketorolac and celecoxib</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Celecoxib</intervention_name>
      <description>The patients received celecoxib in a dose of 400 mg orally daily.</description>
      <arm_group_label>Drug: aspirin, ketorolac and celecoxib</arm_group_label>
      <arm_group_label>Drug: celecoxib</arm_group_label>
      <arm_group_label>Drug: ketorolac and celecoxib</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The patients with diagnosis of osteoarthritis of the knee or hip joint (M15.0, M16,&#xD;
               M17) after primary knee or hip arthroplasty.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or breast feeding women, opioid addiction, patients with severe kidney or&#xD;
               liver disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Federal Center for Traumatology, Orthopedics and Endoprosthetics</name>
        <address>
          <city>Cheboksary</city>
          <state>Chuvashia</state>
          <zip>429500</zip>
          <country>Russian Federation</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Russian Federation</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Postoperative pain</keyword>
    <keyword>Non-steroidal anti-inflammatory drugs</keyword>
    <keyword>Combination of NSAID</keyword>
    <keyword>Aspirin</keyword>
    <keyword>Ketorolac</keyword>
    <keyword>Celecoxib</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Acute Pain</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aspirin</mesh_term>
      <mesh_term>Celecoxib</mesh_term>
      <mesh_term>Ketorolac</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994287
  org study id: 2021-2
  nct id: NCT05994287
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The search for new safe and effective methods of pain relief after surgery on large joints is
        still an urgent problem. The most optimal approach in the treatment of postoperative pain is
        the use of multimodal analgesia with a different mechanism of action that act on various
        mechanisms of pain and can include opioids, nonsteroidal anti-inflammatory drugs (NSAIDs),
        acetaminophen, anticonvulsants, NMDA antagonists, alpha-2-agonists, and sodium and calcium
        channel blocking agents, as well as local anesthetics. NSAIDs are the most popular and safe
        means for pain relief. Therefore, a lot of efforts are aimed at increasing the effectiveness
        of NSAIDs use. The aim of this study was to evaluate the effectiveness of simultaneously
        administering two or three NSAIDs, compared to using only one NSAID, for pain relief after
        surgery on large joints such as hip or knee arthroplasty.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Measuring postoperative pain using the visual analog scale for pain (VAS-P)
  time frame: 5 days
  description: The patients choose the score on the 10 cm line scale with (VAS-P) rage from 0 ('no pain') to 10 (severe pain).
  measure: Arachidonic acid-stimulated platelet tests
  time frame: 5 days
  description: Assessed by Multiplate ASPItest, Roche Diagnostics GmbH. The platelet aggregation expressed in arbitrary aggregation units (AU) multiplied by the recorded time in minutes (AU*min).
  measure: Hemoglobin
  time frame: 5 days
  description: Hemoglobin (HGB) level in g/L
  measure: Hematocrit
  time frame: 5 days
  description: Hematocrit level in %
  measure: Erythrocytes
  time frame: 5 days
  description: Erythrocytes (RBC) number in 1 litter
  measure: Platelets cells
  time frame: 5 days
  description: Platelets cells (PLT) number in 1 litter
  measure: Fibrinogen
  time frame: 5 days
  description: Fibrinogen level in g/L
  measure: Partial thromboplastin time
  time frame: 5 days
  description: Partial thromboplastin time (PTT) in seconds
  measure: Prothrombin time
  time frame: 5 days
  description: Prothrombin time in %
  arm group label: Drug: celecoxib
  arm group type: Active Comparator
  description: The patients received celecoxib in a dose of 400 mg orally daily. The drug was prescribed from the second day of the operation for 5 days.
  arm group label: Drug: aspirin with ketorolac
  arm group type: Experimental
  description: The patients received aspirin in a dose of 100 mg and ketorolac 90 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days.
  arm group label: Drug: ketorolac and celecoxib
  arm group type: Experimental
  description: The patients received ketorolac in a dose of 90 mg and celecoxib 400 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days.
  arm group label: Drug: aspirin, ketorolac and celecoxib
  arm group type: Active Comparator
  description: The patients received aspirin in a dose of 200 mg, ketorolac 90 mg, and celecoxib 400 mg orally daily. The drugs were prescribed from the second day of the operation for 5 days.
  intervention type: Drug
  intervention name: Aspirin
  description: The patients received aspirin in a dose of 100 mg orally daily.
  arm group label: Drug: aspirin with ketorolac
  arm group label: Drug: aspirin, ketorolac and celecoxib
  intervention type: Drug
  intervention name: Ketorolac
  description: The patients received ketorolac in a dose of 90 mg mg orally daily.
  arm group label: Drug: aspirin with ketorolac
  arm group label: Drug: aspirin, ketorolac and celecoxib
  arm group label: Drug: ketorolac and celecoxib
  intervention type: Drug
  intervention name: Celecoxib
  description: The patients received celecoxib in a dose of 400 mg orally daily.
  arm group label: Drug: aspirin, ketorolac and celecoxib
  arm group label: Drug: celecoxib
  arm group label: Drug: ketorolac and celecoxib
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  country: Russian Federation
  responsible party type: Sponsor
  mesh term: Pain, Postoperative
  mesh term: Acute Pain
  mesh term: Aspirin
  mesh term: Celecoxib
  mesh term: Ketorolac