<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/NCT03765723</url>
  </required_header>
  <id_info>
    <org_study_id>SNUMR2-1</org_study_id>
    <nct_id>NCT03765723</nct_id>
  </id_info>
  <brief_title>Prediction Model of Acute Postoperative Pain in Bilateral Total Knee Replacement Arthroplasty Patient</brief_title>
  <official_title>Prediction Model of Acute Postoperative Pain in Bilateral Total Knee Replacement Arthroplasty Patient: Multivariable Model Including &quot;Surgical History Within 2 Weeks&quot; as a Predictive Factor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to predict risk factors of acute postoperative pain of the patients&#xD;
      undergoing Total Knee Replacement Arthroplasty(TKRA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing bilateral TKRA are recruited. The time interval between the surgery of&#xD;
      each leg is within 2 weeks. Before each surgery, patients will be asked to conduct&#xD;
      questionnaires of Hospital Anxiety and Depression Scale(HADS) and Pain Catastrophizing&#xD;
      Scale(PCS). In addition, the patients will have their preoperative knee pain(measured by Knee&#xD;
      injury and Osteoarthritis Outcome Score), preoperative pain in other sites, expectation of&#xD;
      postoperative pain(measured by Numerical Rating Scale), and morbidity of diabetic neuropathy&#xD;
      recorded. Demographic factors including age, sex, and BMI of patients will be collected.&#xD;
      Twenty four and forty eight hours after completion of the surgery, each patient will be asked&#xD;
      to report thier acute postoperative pain on Numerical Rating Scale.&#xD;
&#xD;
      This study aims to find out risk factors of acute postoperative pain, including identical&#xD;
      surgical history within 2 weeks, in patients undergoing bilateral TKRA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2019</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>Acute post operative pain</measure>
    <time_frame>24 hours</time_frame>
    <description>Acute post operative pain is recorded on Numerical Rating Scale(a pain scale ranging from 0 to 10. the higher number means the higher pain) at rest in an attempt to bent knee.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute post operative pain</measure>
    <time_frame>48 hours</time_frame>
    <description>Acute post operative pain is recorded on NRS(a pain scale ranging from 0 to 10. the higher number means the higher pain) at rest in an attempt to bent knee.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Consumption of analgesics</measure>
    <time_frame>48 hours</time_frame>
    <description>Cumulative consumption of Patient-Controlled Analgesia(PCA) and rescue analgesics is recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preoperative anxiety and depression</measure>
    <time_frame>one day before the surgery: 20 hours before the surgery</time_frame>
    <description>Before undergoing TKRA of each leg, patients' preoperative anxiety and depression is recorded on Hospital Anxiety and Depression Scale(HADS) total score.&#xD;
HADS is an instrument for screening for clinically significant anxiety and depression in patients attending a general medical clinic. The scale consists of two subscales: anxiety subscale and depression subscale. Each subscale has seven items and each items are answered by the patient on a four point(0-3) response categories so the possible score ranges from 0 to 21 for anxiety and 0 to 21 for depression(summation). A score of 0 to 7 for either subscale could be regarded as being in normal range, a score of 8-10 being suggestive of the presence of the mood disorder, and a score of 11 or higher indicating probable presence of the respective state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain catastrophizing level</measure>
    <time_frame>one day before the surgery: 20 hours before the surgery</time_frame>
    <description>Before undergoing TKRA of each leg, patients' pain catastrophizing level is recorded on Pain Catastrophizing Scale(PCS) total score.&#xD;
PCS is a thirteen-item instrument to assess patient's catastrophizing on pain experience. The scale consists of three subscales: rumination(4 items), magnification(3 items), and helplessness(4 items). For each items, patients are asked to response on a five point(0-4) categories so the total score is ranging from 0 to 52(summation). A total PCS score of 30 is considered cut-off scores for clinically relevant levels of catastrophizing. The higher score represents high level of catastrophizing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative knee pain</measure>
    <time_frame>one day before the surgery: 20 hours before the surgery</time_frame>
    <description>Before undergoing TKRA of each leg, patients' preoperative knee pain is recorded on Knee injury and Osteoarthritis Outcome Score(KOOS) pain subscale score.&#xD;
KOOS is an instrument to assess pain, symptoms, activities of daily living, sport and recreation function, and knee related quality of life of the patients with ligament injury, meniscus injury, or post traumatic osteoarthritis. A pain subscale of KOOS consists of nine items to assess the level of pain in knee, each item being scored from 0 to 4. A total score of pain subscale ranges from 0 to 36(summation). In this raw scale score on pain, the higher score means the higher level of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative pain in other sites</measure>
    <time_frame>one day before the surgery: 20 hours before the surgery</time_frame>
    <description>Before undergoing TKRA of each leg, patient's preoperative pain in other sites is recorded on NRS(a pain scale ranging from 0 to 10. the higher number means the higher pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain expectation of acute postoperative pain</measure>
    <time_frame>one day before the surgery: 20 hours before the surgery</time_frame>
    <description>Before undergoing TKRA of each leg, patient's pain expectation of acute postoperative pain is recorded on NRS(a pain scale ranging from 0 to 10. the higher number means the higher pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetic neuropathy</measure>
    <time_frame>one day before the surgery: 20 hours before the surgery</time_frame>
    <description>Patient's diabetic neuropathy is recorded by searching electronic medical records or directly asked.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic data</measure>
    <time_frame>one day before the surgery: 20 hours before the surgery</time_frame>
    <description>Patient's age, sex, and BMI is recorded by searching electronic medical records.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Arthritis Knee</condition>
  <condition>Anesthesia</condition>
  <condition>Arthropathy of Knee</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing bilateral TKRA will be recruited from the patients in Seoul National&#xD;
        University Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) patients undergoing bilateral TKRA with spinal anesthesia&#xD;
&#xD;
          -  2) patients who have their second TKRA in one leg within 2 weeks after their first&#xD;
             TKRA in the other leg.&#xD;
&#xD;
          -  3) patients who are classified to the state of ASA physical status classification&#xD;
             system Ⅰ,Ⅱ, or Ⅲ.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) patients incapable of communication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JINTAE KIM, M.D. / Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>JINTAE KIM, M.D. / Ph.D.</last_name>
    <phone>+82-2-2072-2467</phone>
    <email>jintae73@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>JINTAE KIM, M.D / Ph.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin-Tae Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>TKRA</keyword>
  <keyword>Postoperative pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03765723
org study id: SNUMR2-1
nct id: NCT03765723
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to predict risk factors of acute postoperative pain of the patients
      undergoing Total Knee Replacement Arthroplasty(TKRA).
Patients undergoing bilateral TKRA are recruited. The time interval between the surgery of
      each leg is within 2 weeks. Before each surgery, patients will be asked to conduct
      questionnaires of Hospital Anxiety and Depression Scale(HADS) and Pain Catastrophizing
      Scale(PCS). In addition, the patients will have their preoperative knee pain(measured by Knee
      injury and Osteoarthritis Outcome Score), preoperative pain in other sites, expectation of
      postoperative pain(measured by Numerical Rating Scale), and morbidity of diabetic neuropathy
      recorded. Demographic factors including age, sex, and BMI of patients will be collected.
      Twenty four and forty eight hours after completion of the surgery, each patient will be asked
      to report thier acute postoperative pain on Numerical Rating Scale.

      This study aims to find out risk factors of acute postoperative pain, including identical
      surgical history within 2 weeks, in patients undergoing bilateral TKRA.
observational model: Cohort
time perspective: Prospective
measure: Acute post operative pain
time frame: 24 hours
description: Acute post operative pain is recorded on Numerical Rating Scale(a pain scale ranging from 0 to 10. the higher number means the higher pain) at rest in an attempt to bent knee.
measure: Acute post operative pain
time frame: 48 hours
description: Acute post operative pain is recorded on NRS(a pain scale ranging from 0 to 10. the higher number means the higher pain) at rest in an attempt to bent knee.
measure: Consumption of analgesics
time frame: 48 hours
description: Cumulative consumption of Patient-Controlled Analgesia(PCA) and rescue analgesics is recorded.
measure: Preoperative anxiety and depression
time frame: one day before the surgery: 20 hours before the surgery
description: Before undergoing TKRA of each leg, patients' preoperative anxiety and depression is recorded on Hospital Anxiety and Depression Scale(HADS) total score.
HADS is an instrument for screening for clinically significant anxiety and depression in patients attending a general medical clinic. The scale consists of two subscales: anxiety subscale and depression subscale. Each subscale has seven items and each items are answered by the patient on a four point(0-3) response categories so the possible score ranges from 0 to 21 for anxiety and 0 to 21 for depression(summation). A score of 0 to 7 for either subscale could be regarded as being in normal range, a score of 8-10 being suggestive of the presence of the mood disorder, and a score of 11 or higher indicating probable presence of the respective state.
measure: Pain catastrophizing level
time frame: one day before the surgery: 20 hours before the surgery
description: Before undergoing TKRA of each leg, patients' pain catastrophizing level is recorded on Pain Catastrophizing Scale(PCS) total score.
PCS is a thirteen-item instrument to assess patient's catastrophizing on pain experience. The scale consists of three subscales: rumination(4 items), magnification(3 items), and helplessness(4 items). For each items, patients are asked to response on a five point(0-4) categories so the total score is ranging from 0 to 52(summation). A total PCS score of 30 is considered cut-off scores for clinically relevant levels of catastrophizing. The higher score represents high level of catastrophizing.
measure: Preoperative knee pain
time frame: one day before the surgery: 20 hours before the surgery
description: Before undergoing TKRA of each leg, patients' preoperative knee pain is recorded on Knee injury and Osteoarthritis Outcome Score(KOOS) pain subscale score.
KOOS is an instrument to assess pain, symptoms, activities of daily living, sport and recreation function, and knee related quality of life of the patients with ligament injury, meniscus injury, or post traumatic osteoarthritis. A pain subscale of KOOS consists of nine items to assess the level of pain in knee, each item being scored from 0 to 4. A total score of pain subscale ranges from 0 to 36(summation). In this raw scale score on pain, the higher score means the higher level of pain.
measure: Preoperative pain in other sites
time frame: one day before the surgery: 20 hours before the surgery
description: Before undergoing TKRA of each leg, patient's preoperative pain in other sites is recorded on NRS(a pain scale ranging from 0 to 10. the higher number means the higher pain).
measure: Pain expectation of acute postoperative pain
time frame: one day before the surgery: 20 hours before the surgery
description: Before undergoing TKRA of each leg, patient's pain expectation of acute postoperative pain is recorded on NRS(a pain scale ranging from 0 to 10. the higher number means the higher pain).
measure: Diabetic neuropathy
time frame: one day before the surgery: 20 hours before the surgery
description: Patient's diabetic neuropathy is recorded by searching electronic medical records or directly asked.
measure: Demographic data
time frame: one day before the surgery: 20 hours before the surgery
description: Patient's age, sex, and BMI is recorded by searching electronic medical records.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: JINTAE KIM, M.D. / Ph.D.
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: JINTAE KIM, M.D. / Ph.D.
phone: +82-2-2072-2467
email: jintae73@gmail.com
facility: 
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin-Tae Kim
investigator title: Professor
mesh term: Pain, Postoperative
sharing ipd: No