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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03792828

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: Duloxetine HCl 30mg	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Pre-emptive Effect of Duloxetine in the Second Knee in Staged Total Knee Arthroplasty: A Randomized Controlled Study

Anticipated Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Duloxetine HCl 30mg is not used.	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.
Experimental: Duloxetine 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.

Arm

Intervention/Treatment

Active Comparator: Control

Duloxetine HCl 30mg is not used.

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.

Experimental: Duloxetine

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

Outcome Measures

Primary Outcome Measures

Pain VAS [day 7 (inpatient)]
Pain VAS(11-point numeric scale: 0-11) at rest, maximal knee flexion and maximal knee extension

Secondary Outcome Measures

Central censitization [Preop. day 1, 2, 7 (inpatient) , Postop. 6 week, 3 month]
DN4 (Douleur Neuropathique 4)
Opioid consumption [Preop. day 1, 2, 7 (inpatient) , Postop. 6 week, 3 month]
Opioid conversion to Morphine IV
Pain VAS [Preop. day 1, 2 (inpatient) , Postop. 6 week, 3 month]
Pain VAS(11-point numeric scale: 0-11) at rest, maximal knee flexion and maximal knee extension

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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