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

January 1, 2019 updated by: Seung-Baik Kang, Seoul National University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 07061
        • Seoul National University Boramae Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain VAS
Time Frame: day 7 (inpatient)
Pain VAS(11-point numeric scale: 0-11) at rest, maximal knee flexion and maximal knee extension
day 7 (inpatient)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central censitization
Time Frame: Preop. day 1, 2, 7 (inpatient) , Postop. 6 week, 3 month
DN4 (Douleur Neuropathique 4)
Preop. day 1, 2, 7 (inpatient) , Postop. 6 week, 3 month
Opioid consumption
Time Frame: Preop. day 1, 2, 7 (inpatient) , Postop. 6 week, 3 month
Opioid conversion to Morphine IV
Preop. day 1, 2, 7 (inpatient) , Postop. 6 week, 3 month
Pain VAS
Time Frame: 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
Preop. day 1, 2 (inpatient) , Postop. 6 week, 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Seung-Baik Kang, MD, PhD, SMG-SNU Boramae Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 28, 2018

First Submitted That Met QC Criteria

January 1, 2019

First Posted (Actual)

January 3, 2019

Study Record Updates

Last Update Posted (Actual)

January 3, 2019

Last Update Submitted That Met QC Criteria

January 1, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBMC_20181128

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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