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

NCT03792828 | Unknown Phase 4

• 1 other identifier: SNUBMC_20181128
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

total knee replacement arthroplasty; total knee arthroplasty; central censitization; duloxetine; serotonin-norepinephrine reuptake inhibitors; pre-emptive effect

Outcome Measures

Primary Outcomes (1)

• Pain VAS

  Pain VAS(11-point numeric scale: 0-11) at rest, maximal knee flexion and maximal knee extension

  day 7 (inpatient)

Secondary Outcomes (3)

• Central censitization

  Preop. day 1, 2, 7 (inpatient) , Postop. 6 week, 3 month

• Opioid consumption

  Preop. day 1, 2, 7 (inpatient) , Postop. 6 week, 3 month

• Pain VAS

  Preop. day 1, 2 (inpatient) , Postop. 6 week, 3 month

Study Arms (2)

Control

ACTIVE COMPARATOR

Duloxetine HCl 30mg is not used.

Drug: Duloxetine HCl 30mg

Duloxetine

EXPERIMENTAL

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

Interventions

Duloxetine HCl 30mg 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.

Control; Duloxetine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Related Publications (9)

• Shin HJ, Kim EY, Na HS, Kim TK, Kim MH, Do SH. Magnesium sulphate attenuates acute postoperative pain and increased pain intensity after surgical injury in staged bilateral total knee arthroplasty: a randomized, double-blinded, placebo-controlled trial. Br J Anaesth. 2016 Oct;117(4):497-503. doi: 10.1093/bja/aew227. Epub 2016 Oct 17.

  PMID: 28077538 BACKGROUND

• 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.

  PMID: 24891574 BACKGROUND

• 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.

  PMID: 24426845 BACKGROUND

• Sun J, Li L, Yuan S, Zhou Y. Analysis of Early Postoperative Pain in the First and Second Knee in Staged Bilateral Total Knee Arthroplasty: A Retrospective Controlled Study. PLoS One. 2015 Jun 11;10(6):e0129973. doi: 10.1371/journal.pone.0129973. eCollection 2015.

  PMID: 26068371 BACKGROUND

• Kumar V, Bin Abd Razak HR, Chong HC, Tan AH. Functional Outcomes of the Second Surgery Are Similar to the First in Asians Undergoing Staged-Bilateral Total Knee Arthroplasty. Ann Acad Med Singap. 2015 Nov;44(11):514-8.

  PMID: 27089957 BACKGROUND

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

  PMID: 28913467 BACKGROUND

• 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.

  PMID: 16877597 BACKGROUND

• 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.

  PMID: 23994101 BACKGROUND

• 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.

  PMID: 27387351 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Seung-Baik Kang, MD, PhD

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung-Baik Kang, MD, PhD

CONTACT

+82-870-3931; ossbkang@gmail.com

JoungYoup Shin, MD

CONTACT

+82-10-5310-7133; sjy820828@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: January 3, 2019
• Study Start: January 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 3, 2019

Record last verified: 2019-01

Locations

KR (1)