A Phase 4 interventional study of Duloxetine HCl 30mg in Knee Osteoarthritis, sponsored by Seoul National University Hospital. Status unknown at 1 site in South Korea. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-01-03.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
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.
Degenerative arthritis of the knee is one of the most common arthritis. Currently, total knee arthroplasty is the most commonly used surgical procedure. The degenerative changes of the knee are often seen on both sides, and bilateral total knee arthroplasty is usually performed. In the past, bilateral total knee arthroplasty was performed at the same time. When bilateral total knee arthroplasty was performed simultaneously, the complications such as increased mortality occurred. So, it is common to perform bilateral total knee arthroplasty in a stepwise manner.
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 blood loss 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 1) whether the pain is greater than the first operation at the second operation in the control group. 2) whether the pre-operative and post-operative duloxetine use causes the pre-analgesic effect on the second operation. 3) whether the central sensitization, clinical score, and painkiller usage are different by comparing duloxetine-treated group and control group.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's planned enrollment of 90 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
Duloxetine HCl 30mg is not used.
Drug: Duloxetine HCl 30mg
One capsule of Duloxetine HCl 30mg (Duroceptol) is taken orally and daily from the day before the first operation to seven days after the second operation.
Drug: Duloxetine HCl 30mg
In the duloxetine group, one capsule of Duloxetine HCl 30mg (Duroceptol) is taken orally and daily from the day before the first operation to seven days after the second operation. In the control group, the patients can take painkillers except duloxetine.
Pain VAS
Pain VAS(11-point numeric scale: 0-11) at rest, maximal knee flexion and maximal knee extension
Time frame: day 7 (inpatient)
Central censitization
DN4 (Douleur Neuropathique 4)
Time frame: Preop. day 1, 2, 7 (inpatient) , Postop. 6 week, 3 month
Opioid consumption
Opioid conversion to Morphine IV
Time frame: Preop. day 1, 2, 7 (inpatient) , Postop. 6 week, 3 month
Pain VAS
Pain VAS(11-point numeric scale: 0-11) at rest, maximal knee flexion and maximal knee extension
Time frame: Preop. day 1, 2 (inpatient) , Postop. 6 week, 3 month
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Duloxetine
Seoul National University Hospital →