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

NCT ID: NCT03792828

Last Updated: 2019-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2019-12-31

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.

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Duloxetine HCl 30mg is not used.

Group Type: ACTIVE_COMPARATOR

Duloxetine HCl 30mg

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Duloxetine HCl 30mg

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seung-Baik Kang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seung-Baik Kang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Locations

Seoul National University Boramae Medical Center

Seoul, , South Korea

Countries

South Korea

Central Contacts

Seung-Baik Kang, MD, PhD

Role: CONTACT

ossbkang@gmail.com

+82-870-3931

JoungYoup Shin, MD

Role: CONTACT

sjy820828@gmail.com

+82-10-5310-7133

Facility Contacts

Seung-Baik Kang, MD, PhD

Role: primary

ossbkang@gmail.com

+82-2-870-3931

References

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Reference Type: BACKGROUND

PMID: 28077538 (View on PubMed)

Scott CE, Murray RC, MacDonald DJ, Biant LC. Staged bilateral total knee replacement: changes in expectations and outcomes between the first and second operations. Bone Joint J. 2014 Jun;96-B(6):752-8. doi: 10.1302/0301-620X.96B6.32793.

Reference Type: BACKGROUND

PMID: 24891574 (View on PubMed)

Hussain N, Chien T, Hussain F, Bookwala A, Simunovic N, Shetty V, Bhandari M. Simultaneous versus staged bilateral total knee arthroplasty: a meta-analysis evaluating mortality, peri-operative complications and infection rates. HSS J. 2013 Feb;9(1):50-9. doi: 10.1007/s11420-012-9315-7. Epub 2013 Jan 24.

Reference Type: BACKGROUND

PMID: 24426845 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 26068371 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 27089957 (View on PubMed)

Onutu AH. Duloxetine, an antidepressant with analgesic properties - a preliminary analysis. Rom J Anaesth Intensive Care. 2015 Oct;22(2):123-128.

Reference Type: BACKGROUND

PMID: 28913467 (View on PubMed)

Forster MC, Bauze AJ, Bailie AG, Falworth MS, Oakeshott RD. A retrospective comparative study of bilateral total knee replacement staged at a one-week interval. J Bone Joint Surg Br. 2006 Aug;88(8):1006-10. doi: 10.1302/0301-620X.88B8.17862.

Reference Type: BACKGROUND

PMID: 16877597 (View on PubMed)

Kim MH, Nahm FS, Kim TK, Chang MJ, Do SH. Comparison of postoperative pain in the first and second knee in staged bilateral total knee arthroplasty: clinical evidence of enhanced pain sensitivity after surgical injury. Pain. 2014 Jan;155(1):22-27. doi: 10.1016/j.pain.2013.08.027. Epub 2013 Aug 30.

Reference Type: BACKGROUND

PMID: 23994101 (View on PubMed)

YaDeau JT, Brummett CM, Mayman DJ, Lin Y, Goytizolo EA, Padgett DE, Alexiades MM, Kahn RL, Jules-Elysee KM, Fields KG, Goon AK, Gadulov Y, Westrich G. Duloxetine and Subacute Pain after Knee Arthroplasty when Added to a Multimodal Analgesic Regimen: A Randomized, Placebo-controlled, Triple-blinded Trial. Anesthesiology. 2016 Sep;125(3):561-72. doi: 10.1097/ALN.0000000000001228.

Reference Type: BACKGROUND

PMID: 27387351 (View on PubMed)

Other Identifiers

SNUBMC_20181128

Identifier Type: -

Identifier Source: org_study_id