Pre-emptive Effect of Duloxetine in the Second Knee in Staged Total Knee Arthroplasty

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In Korea, the interval between knee arthroplasties is usually 1 week. According to previous studies, when total knee arthroplasty was performed at 1-week intervals, total bleeding was reduced and the period of hospital stay was shortened.

However, if stepwise total knee arthroplasty is performed at intervals of one week, the pain is greater after the second operation, and the reason for this phenomenon is known to be due to central sensitization and opioid resistance.

Therefore, the investigators aim to confirm whether Duloxetine reduces the central sensitization as previously known and affects the pain control after the second operation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• Candidate for staged bilateral total knee replacement arthroplasty due to osteoarthritis of the knee.

Exclusion Criteria:

• Known allergic reaction to duloxetine

• Secondary arthritis (ex. Rheumatic arthritis, traumatic arthritis, septic arthritis)

• History of major operation(ex. Arthroscopic knee arthroplasty, osteotomy, open reduction, and internal fixation)

• History of manic or bipolar disorder, epilepsy, increased intraocular pressure or risk of acute angle-closure glaucoma, liver disease, moderate renal disease (CLcr < 30ml/min), severe heart disease, uncontrolled hypertension, unregulated narrow-angle glaucoma

• Known congenital or acquired coagulopathy

• Known genetic disorders such as fulminant intolerance / glucose-galactose uptake disorder/sucrose isoleucetase deficiency

• Taken MAO inhibitor, anti-depressants, diuretics, duloxetine

• Refuse to participate in the study