Arthritis KneeNCT03765723
Prediction Model of Acute Postoperative Pain in Bilateral Total Knee Replacement Arthroplasty Patient
An observational study of Arthritis Knee and Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to predict risk factors of acute postoperative pain of the patients undergoing Total Knee Replacement Arthroplasty(TKRA). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Arthritis Knee, Anesthesia, Arthropathy of Knee
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing bilateral TKRA will be recruited from the patients in Seoul National University Hospital.
Who may be able to join
- 1) patients undergoing bilateral TKRA with spinal anesthesia
- 2) patients who have their second TKRA in one leg within 2 weeks after their first TKRA in the other leg.
- 3) patients who are classified to the state of ASA physical status classification system Ⅰ,Ⅱ, or Ⅲ.
Who cannot join
- 1) patients incapable of communication
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, 03080
JINTAE KIM, M.D / Ph.D.
About this study
Official title: Prediction Model of Acute Postoperative Pain in Bilateral Total Knee Replacement Arthroplasty Patient: Multivariable Model Including "Surgical History Within 2 Weeks" as a Predictive Factor
This study aims to predict risk factors of acute postoperative pain of the patients undergoing Total Knee Replacement Arthroplasty(TKRA).
Read the detailed description
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.
- Conditions
- Arthritis Knee, Anesthesia, Arthropathy of Knee
- Keywords
- TKRA, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute post operative pain
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.
Measured: 24 hours
Acute post operative pain
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.
Measured: 48 hours
Consumption of analgesics
Cumulative consumption of Patient-Controlled Analgesia(PCA) and rescue analgesics is recorded.
Measured: 48 hours
Secondary outcomes (7)
Preoperative anxiety and depression
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.
Measured: one day before the surgery: 20 hours before the surgery
Pain catastrophizing level
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.
Measured: one day before the surgery: 20 hours before the surgery
Preoperative knee pain
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.
Measured: one day before the surgery: 20 hours before the surgery
Preoperative pain in other sites
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).
Measured: one day before the surgery: 20 hours before the surgery
Pain expectation of acute postoperative pain
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).
Measured: one day before the surgery: 20 hours before the surgery
Diabetic neuropathy
Patient's diabetic neuropathy is recorded by searching electronic medical records or directly asked.
Measured: one day before the surgery: 20 hours before the surgery
Demographic data
Patient's age, sex, and BMI is recorded by searching electronic medical records.
Measured: one day before the surgery: 20 hours before the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- JINTAE KIM, M.D. / Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765723
- Sponsor's protocol ID
- SNUMR2-1
- Status last verified
- Dec 2018
- First submitted
- 30 Nov 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model of Acute Postoperative Pain in Bilateral Total Knee Replacement Arthroplasty Patient: Multivariable Model Including "Surgical History Within 2 Weeks" as a Predictive Factor
- ClinicalTrials.gov ID
- NCT03765723
- Acronym / sponsor ID
- SNUMR2-1
- Conditions
- Arthritis Knee, Anesthesia, Arthropathy of Knee
- Keywords
- TKRA, Postoperative pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to predict risk factors of acute postoperative pain of the patients undergoing Total Knee Replacement Arthroplasty(TKRA).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing bilateral TKRA will be recruited from the patients in Seoul National University Hospital.
Key inclusion criteria (3 listed)
- 1) patients undergoing bilateral TKRA with spinal anesthesia
- 2) patients who have their second TKRA in one leg within 2 weeks after their first TKRA in the other leg.
- 3) patients who are classified to the state of ASA physical status classification system Ⅰ,Ⅱ, or Ⅲ.
Key exclusion criteria (1 listed)
- 1) patients incapable of communication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute post operative pain
Time frame: 24 hours
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.
Acute post operative pain
Time frame: 48 hours
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.
Consumption of analgesics
Time frame: 48 hours
Cumulative consumption of Patient-Controlled Analgesia(PCA) and rescue analgesics is recorded.
7 secondary outcomes
Preoperative anxiety and depression
Time frame: one day before the surgery: 20 hours before the surgery
Pain catastrophizing level
Time frame: one day before the surgery: 20 hours before the surgery
Preoperative knee pain
Time frame: one day before the surgery: 20 hours before the surgery
Preoperative pain in other sites
Time frame: one day before the surgery: 20 hours before the surgery
Pain expectation of acute postoperative pain
Time frame: one day before the surgery: 20 hours before the surgery
Diabetic neuropathy
Time frame: one day before the surgery: 20 hours before the surgery
Demographic data
Time frame: one day before the surgery: 20 hours before the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JINTAE KIM, M.D. / Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis Knee and Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JINTAE KIM, M.D. / Ph.D. (+82-2-2072-2467, jintae73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute post operative pain (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.