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Clinical Trials/NCT03765723
NCT03765723
Unknown
Not Applicable

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

Seoul National University Hospital1 site in 1 country100 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthritis Knee
Sponsor
Seoul National University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Consumption of analgesics
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 31, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jin-Tae Kim

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • patients undergoing bilateral TKRA with spinal anesthesia
  • patients who have their second TKRA in one leg within 2 weeks after their first TKRA in the other leg.
  • patients who are classified to the state of ASA physical status classification system Ⅰ,Ⅱ, or Ⅲ.

Exclusion Criteria

  • patients incapable of communication

Outcomes

Primary Outcomes

Consumption of analgesics

Time Frame: 48 hours

Cumulative consumption of Patient-Controlled Analgesia(PCA) and rescue analgesics is recorded.

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.

Secondary Outcomes

  • Preoperative anxiety and depression(one day before the surgery: 20 hours before the surgery)
  • Diabetic neuropathy(one day before the surgery: 20 hours before the surgery)
  • Pain expectation of acute postoperative pain(one day before the surgery: 20 hours before the surgery)
  • Pain catastrophizing level(one day before the surgery: 20 hours before the surgery)
  • Preoperative knee pain(one day before the surgery: 20 hours before the surgery)
  • Demographic data(one day before the surgery: 20 hours before the surgery)
  • Preoperative pain in other sites(one day before the surgery: 20 hours before the surgery)

Study Sites (1)

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