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临床试验/NCT03765723
NCT03765723Unknown不适用

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 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Consumption of analgesics

研究概览

简要总结

This study aims to predict risk factors of acute postoperative pain of the patients undergoing Total Knee Replacement Arthroplasty(TKRA).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • patients incapable of communication

结局指标

主要结局

Consumption of analgesics

时间窗: 48 hours

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

Acute post operative pain

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin-Tae Kim

Professor

Seoul National University Hospital

研究点 (1)

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