Clinical trial NCT03765723: Prediction Model of Acute Postoperative Pain in Bilateral Total Knee Replacement Arthroplasty Patient
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis Knee
Anesthesia
Arthropathy of Knee
Keywords: TKRA
Postoperative pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing bilateral TKRA will be recruited from the patients in Seoul National University Hospital.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 1) patients incapable of communication

Primary outcomes:
measure: Acute post operative pain
timeFrame: 24 hours
measure: Acute post operative pain
timeFrame: 48 hours
measure: Consumption of analgesics
timeFrame: 48 hours
Secondary outcomes:
measure: Preoperative anxiety and depression
timeFrame: one day before the surgery: 20 hours before the surgery
measure: Pain catastrophizing level
timeFrame: one day before the surgery: 20 hours before the surgery
measure: Preoperative knee pain
timeFrame: one day before the surgery: 20 hours before the surgery
measure: Preoperative pain in other sites
timeFrame: one day before the surgery: 20 hours before the surgery
measure: Pain expectation of acute postoperative pain
timeFrame: one day before the surgery: 20 hours before the surgery
measure: Diabetic neuropathy
timeFrame: one day before the surgery: 20 hours before the surgery
measure: Demographic data
timeFrame: one day before the surgery: 20 hours before the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: JINTAE KIM, M.D. / Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: