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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03765723
• Other study ID #: SNUMR2-1
• Status: Not yet recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2018
• Source: Seoul National University Hospital
• Contact: JINTAE KIM, M.D. / Ph.D.
• Phone: +82-2-2072-2467
• Email: jintae73[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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 ?,?, or ?.

Exclusion Criteria:

• 1) patients incapable of communication

Related Conditions & MeSH terms

• Anesthesia
• Arthritis Knee
• Arthropathy of Knee
• Joint Diseases
• Pain, Postoperative

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Consumption of analgesics	Cumulative consumption of Patient-Controlled Analgesia(PCA) and rescue analgesics is recorded.	48 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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