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/NCT05997238</url>
    </required_header>
    <id_info>
      <org_study_id>Triamcinolone68480</org_study_id>
      <nct_id>NCT05997238</nct_id>
    </id_info>
    <brief_title>Evaluation of the Effect of Triamcinolone at Different Doses on LIA During TKA</brief_title>
    <acronym>LIA;TKA</acronym>
    <official_title>Evaluation of the Effect of Triamcinolone at Different Doses on Local Infiltration Anesthesia During Total Knee Arthroplasty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University Third Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To evaluate the efficacy and safety of different doses of triamcinolone for local&#xD;
        infiltration analgesia during total knee replacement&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants were enrolled according to protocol requirements. Patients who meet all&#xD;
        inclusion criteria and do not have any exclusion criteria will be considered for inclusion in&#xD;
        the study and will provide the relevant information used orally and in writing. Patients were&#xD;
        divided into two groups according to the dose of triamcinolone in the peripheral infiltrating&#xD;
        anesthetic preparation. All of which are appropriate for their surgical treatment, and the&#xD;
        purpose of the study is to determine which formula is clinically better. All patients&#xD;
        enrolled in this study were voluntary participants and signed informed consent. On the day of&#xD;
        the surgery, the anesthesiologist prepares a mixture of medications based on patient groups,&#xD;
        which are then handed to the operating room nurse. The timing, dose, and site of injection&#xD;
        were consistent. Before the prosthesis is installed, the mixture is injected into the upper&#xD;
        part of the patella, the posterior joint capsule, and the patellar tendon. After the&#xD;
        prosthesis was installed, the mixture was injected into the lateral joint capsule and&#xD;
        subcutaneous tissue. The patient, the rehabilitation physician, and the ward nurse did not&#xD;
        know the type of mixed drug preparation injected by the patient.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 25, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Knee range of motion</measure>
      <time_frame>Postoperative day 1</time_frame>
      <description>The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Knee range of motion</measure>
      <time_frame>Postoperative day 2</time_frame>
      <description>The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Knee range of motion</measure>
      <time_frame>Postoperative day 3</time_frame>
      <description>The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Blood routine</measure>
      <time_frame>Postoperative day 1</time_frame>
      <description>Assay index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood routine</measure>
      <time_frame>Postoperative day 2</time_frame>
      <description>Assay index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood routine</measure>
      <time_frame>Postoperative day 3</time_frame>
      <description>Assay index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Test index of drainage liquefaction</measure>
      <time_frame>Postoperative day 1</time_frame>
      <description>Assay index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complication rate</measure>
      <time_frame>Three months after surgery</time_frame>
      <description>Follow-up visit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index</measure>
      <time_frame>Three months after surgery</time_frame>
      <description>The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; range from 0 to 100; A higher score indicates better knee function</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Morphine intake in 48 hours after surgery</measure>
      <time_frame>48 hours after surgery</time_frame>
      <description>The patient's use of additional analgesic drugs was recorded through the doctor's order system and converted to morphine equivalent</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pain visual analogue scale score</measure>
      <time_frame>2 hours after surgery</time_frame>
      <description>pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pain visual analogue scale score</measure>
      <time_frame>4 hours after surgery</time_frame>
      <description>pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pain visual analogue scale score</measure>
      <time_frame>8 hours after surgery</time_frame>
      <description>pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pain visual analogue scale score</measure>
      <time_frame>24 hours after surgery</time_frame>
      <description>pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pain visual analogue scale score</measure>
      <time_frame>48 hours after surgery</time_frame>
      <description>pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pain visual analogue scale score</measure>
      <time_frame>72 hours after surgery</time_frame>
      <description>pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pain visual analogue scale score</measure>
      <time_frame>2 weeks after surgery</time_frame>
      <description>pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pain visual analogue scale score</measure>
      <time_frame>4 weeks after surgery</time_frame>
      <description>pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pain visual analogue scale score</measure>
      <time_frame>8 weeks after surgery</time_frame>
      <description>pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pain visual analogue scale score</measure>
      <time_frame>12 weeks after surgery</time_frame>
      <description>pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Osteoarthritis, Knee</condition>
    <arm_group>
      <arm_group_label>low-dose triamcinolone group</arm_group_label>
      <description>add 40mg triamcinolone to the LIA preparation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>high-dose triamcinolone group</arm_group_label>
      <description>add 80mg triamcinolone to the LIA preparation</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>80mg triamcinolone</intervention_name>
      <description>80mg triamcinolone was added to the preparation</description>
      <arm_group_label>high-dose triamcinolone group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>40mg triamcinolone</intervention_name>
      <description>40mg triamcinolone was added to the preparation</description>
      <arm_group_label>low-dose triamcinolone group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Drainage fluid, blood&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          patients with knee osteoarthritis requiring primary unilateral total knee replacement&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. age in the range of 50 to 85 years old&#xD;
  &#xD;
            2. patients with knee osteoarthritis requiring primary unilateral total knee replacement&#xD;
  &#xD;
            3. the body mass index in the range of 18 to 36 kg/m2&#xD;
  &#xD;
            4. possess the physical status I-III of American Society of Anesthesiologists&#xD;
  &#xD;
            5. the patient and his family members agree and sign the informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Non-osteoarthritis (rheumatoid arthritis, traumatic arthritis, septicemic arthritis,&#xD;
               etc.)&#xD;
  &#xD;
            2. History of knee surgery or knee injury, such as high tibial osteotomy, meniscus&#xD;
               repair, ligament reconstruction, etc&#xD;
  &#xD;
            3. Flexion deformity ≥30°, internal and external varus deformity ≥15°&#xD;
  &#xD;
            4. People allergic to the drugs used in this study&#xD;
  &#xD;
            5. Patients who had used glucocorticoids within 3 months before surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tian Hua, doctor</last_name>
      <role>Study Chair</role>
      <affiliation>Director</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tian Hua, doctor</last_name>
      <phone>86-18811185091</phone>
      <email>tianhua@bjmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zheng Yuhang, bachelor</last_name>
      <phone>86-18810107656</phone>
      <email>1710301104@pku.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking University Third Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100181</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tian Hua, doctor</last_name>
        <phone>86-18811185091</phone>
        <email>tianhua@bjmu.edu.cn</email>
      </contact>
      <contact_backup>
        <last_name>Zheng Yuhang, bachelor</last_name>
        <phone>86-18811185091</phone>
        <email>1710301104@pku.edu.cn</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>May 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>total knee arthroplasty</keyword>
    <keyword>triamcinolone</keyword>
    <keyword>local infiltration anesthesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Triamcinolone</mesh_term>
      <mesh_term>Triamcinolone Acetonide</mesh_term>
      <mesh_term>Triamcinolone hexacetonide</mesh_term>
      <mesh_term>Triamcinolone diacetate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05997238
  org study id: Triamcinolone68480
  nct id: NCT05997238
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  To evaluate the efficacy and safety of different doses of triamcinolone for local
        infiltration analgesia during total knee replacement
  Participants were enrolled according to protocol requirements. Patients who meet all
        inclusion criteria and do not have any exclusion criteria will be considered for inclusion in
        the study and will provide the relevant information used orally and in writing. Patients were
        divided into two groups according to the dose of triamcinolone in the peripheral infiltrating
        anesthetic preparation. All of which are appropriate for their surgical treatment, and the
        purpose of the study is to determine which formula is clinically better. All patients
        enrolled in this study were voluntary participants and signed informed consent. On the day of
        the surgery, the anesthesiologist prepares a mixture of medications based on patient groups,
        which are then handed to the operating room nurse. The timing, dose, and site of injection
        were consistent. Before the prosthesis is installed, the mixture is injected into the upper
        part of the patella, the posterior joint capsule, and the patellar tendon. After the
        prosthesis was installed, the mixture was injected into the lateral joint capsule and
        subcutaneous tissue. The patient, the rehabilitation physician, and the ward nurse did not
        know the type of mixed drug preparation injected by the patient.
  observational model: Cohort
  time perspective: Prospective
  measure: Knee range of motion
  time frame: Postoperative day 1
  description: The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
  measure: Knee range of motion
  time frame: Postoperative day 2
  description: The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
  measure: Knee range of motion
  time frame: Postoperative day 3
  description: The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
  measure: Blood routine
  time frame: Postoperative day 1
  description: Assay index
  measure: Blood routine
  time frame: Postoperative day 2
  description: Assay index
  measure: Blood routine
  time frame: Postoperative day 3
  description: Assay index
  measure: Test index of drainage liquefaction
  time frame: Postoperative day 1
  description: Assay index
  measure: Complication rate
  time frame: Three months after surgery
  description: Follow-up visit
  measure: The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
  time frame: Three months after surgery
  description: The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; range from 0 to 100; A higher score indicates better knee function
  measure: Morphine intake in 48 hours after surgery
  time frame: 48 hours after surgery
  description: The patient's use of additional analgesic drugs was recorded through the doctor's order system and converted to morphine equivalent
  measure: pain visual analogue scale score
  time frame: 2 hours after surgery
  description: pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
  measure: pain visual analogue scale score
  time frame: 4 hours after surgery
  description: pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
  measure: pain visual analogue scale score
  time frame: 8 hours after surgery
  description: pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
  measure: pain visual analogue scale score
  time frame: 24 hours after surgery
  description: pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
  measure: pain visual analogue scale score
  time frame: 48 hours after surgery
  description: pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
  measure: pain visual analogue scale score
  time frame: 72 hours after surgery
  description: pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
  measure: pain visual analogue scale score
  time frame: 2 weeks after surgery
  description: pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
  measure: pain visual analogue scale score
  time frame: 4 weeks after surgery
  description: pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
  measure: pain visual analogue scale score
  time frame: 8 weeks after surgery
  description: pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
  measure: pain visual analogue scale score
  time frame: 12 weeks after surgery
  description: pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
  arm group label: low-dose triamcinolone group
  description: add 40mg triamcinolone to the LIA preparation
  arm group label: high-dose triamcinolone group
  description: add 80mg triamcinolone to the LIA preparation
  intervention type: Drug
  intervention name: 80mg triamcinolone
  description: 80mg triamcinolone was added to the preparation
  arm group label: high-dose triamcinolone group
  intervention type: Drug
  intervention name: 40mg triamcinolone
  description: 40mg triamcinolone was added to the preparation
  arm group label: low-dose triamcinolone group
  Drainage fluid, blood
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Tian Hua, doctor
  role: Study Chair
  affiliation: Director
  last name: Tian Hua, doctor
  phone: 86-18811185091
  email: tianhua@bjmu.edu.cn
  last name: Zheng Yuhang, bachelor
  phone: 86-18810107656
  email: 1710301104@pku.edu.cn
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Osteoarthritis, Knee
  mesh term: Triamcinolone
  mesh term: Triamcinolone Acetonide
  mesh term: Triamcinolone hexacetonide
  mesh term: Triamcinolone diacetate
  sharing ipd: Undecided