Prediction Model of Acute Postoperative Pain in Bilateral Total Knee Replacement Arthroplasty Patient

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).

Study Overview

• Status: Unknown
• Conditions: Anesthesia; Arthropathy of Knee; Arthritis Knee

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing bilateral TKRA will be recruited from the patients in Seoul National University Hospital.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	48 hours
Consumption of analgesics	Cumulative consumption of Patient-Controlled Analgesia(PCA) and rescue analgesics is recorded.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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).	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.	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.	one day before the surgery: 20 hours before the surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: JINTAE KIM, M.D. / Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): October 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Postoperative pain; TKRA
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: SNUMR2-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No