NCT02600247

Brief Summary

This study aims to compare the effectiveness of duloxetine after total knee arthroplasty in Central sensitization patient. Central sensitization plays an important role in the chronic pain experienced by osteoarthritis patients.Elimination of the nociceptive input from the damaged joint by total joint arthroplasty was not always followed by a complete resolution of symptoms. Patients with high levels of preoperative pain and low pain thresholds had a higher risk of persistent pain after total knee arthroplasty (TKA), which has been interpreted as evidence of central sensitization. Thus, the presence of central sensitization before surgery in Osteoarthritis patients may be an important contributing factor to postoperative pain versus adequate analgesia. Preclinical models of central sensitization suggest that duloxetine is effective in the treatment of persistent pain. Investigators will compare the pain following TKA of central sensitization patients in duloxetine group (n=50) with those in non-duloxetine group (n=84). Investigators will classify the central sensitization patients by central sensitization inventory and divide the central sensitization patients in to 2 groups (duloxetine and non-duloxetine group) randomly. Investigators checks the visual assessment scale at preoperative, postoperative 1, 2,6,12 weeks. All participants will receive postoperative pain control after TKA using the same pain control regimen except duloxetine.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 9, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

November 5, 2015

Last Update Submit

November 6, 2015

Conditions

Osteoarthritis

Keywords

Total knee arthroplastyDuloxetine

Outcome Measures

Primary Outcomes (1)

  • Visual pain scale

    Preoperative & postoperative 1, 2, 6, 12 weeks

Secondary Outcomes (2)

  • SF(Short form)- 36 scale(Preoperative and postoperative 6, 12 weeks)

    Preoperative and postoperative 6, 12 weeks

  • Brief pain inventory

    Preoperative and postoperative 1, 6, 12 weeks

Study Arms (2)

Duloxetine group

EXPERIMENTAL

Experimental: Duloxetine group 1. Phase I (preemptive): 1day before operation (30mg for 1 day) 2. Phase II (maintenance): 6weeks after operation (30mg for 6 weeks) plus routine pain control (celecoxib, pregabalin, acetaminophen/tramadol, oxycodone) Other Name: cymbalta Drug: Celebrex, Lyrica, Ultracet, Ircodon

Drug: DuloxetineDrug: celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone

routine pain control group

ACTIVE COMPARATOR

Preemptive analgesia : celebrex 200mg 1C#1, Lyrica 150mg 1C#1 (preoperation. 2 hours), Patient controlled analgesia (postoperation 28 hours) During admission : celebrex 200mg#1, Ircodon 5mg 2T#2, Ultracet 2T#2 (Postoperation 1 week) Discharge medication: celebrex 200mg 1C#1 x 5Weeks, Ultracet 2T#2 x 1 week Other name : celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone

Drug: celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone

Interventions

DuloxetineDRUG

Experimental: Duloxetine group 1. Phase I (preemptive): 1day before operation (30mg for 1 day) 2. Phase II (maintenance): 6weeks after operation (30mg for 6 weeks) plus routine pain control (celecoxib, pregabalin, acetaminophen/tramadol, oxycodone) Other Name: cymbalta Drug: Celebrex, Lyrica, Ultracet, Ircodon Preemptive analgesia : celebrex 200mg 1C#1, Lyrica 150mg 1C#1 (preoperation. 2 hours), Patient controlled analgesia (postoperation 28 hours) During admission : celebrex 200mg#1, Ircodon 5mg 2T#2, Ultracet 2T#2 (Postoperation 1 week) Discharge medication: celebrex 200mg 1C#1 x 5Weeks, Ultracet 2T#2 x 1 week Other name : celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone

Duloxetine group
celecoxib, Pregabalin, acetaminophen/tramadol, oxycodoneDRUG

Preemptive analgesia : celebrex 200mg 1C#1, Lyrica 150mg 1C#1 (preoperation. 2 hours), Patient controlled analgesia (postoperation 28 hours) During admission : celebrex 200mg#1, Ircodon 5mg 2T#2, Ultracet 2T#2 (Postoperation 1 week) Discharge medication: celebrex 200mg 1C#1 x 5Weeks, Ultracet 2T#2 x 1 week Other name : celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone

Duloxetine grouproutine pain control group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients for total knee arthroplasty
  • having medicare insurance
  • CSI(Central sensitization inventory)\> 40 (Central sensitization patient )

You may not qualify if:

  • Rheumatoid arthritis
  • Other inflammatory arthritis
  • Neuropsychiatric patients
  • Allergy or intolerance to study medications
  • Patients with an ASA(American society of anesthesiologist) classification of IV (angina, congestive heart failure, dementia, cerebrovascular accident)
  • Chronic gabapentin or pregabalin use (regular use for longer than 3 months)
  • Chronic opioid use (taking opioids for longer than 3 months)
  • Alcohol, drug abuser
  • Narcotics addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Interventions

Duloxetine HydrochlorideCelecoxibPregabalinAcetaminophenTramadolOxycodone

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzenesulfonamidesSulfonamidesAmidesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesPyrazolesAzolesgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsAmino AcidsAmino Acids, Peptides, and ProteinsAcetanilidesAnilidesAniline CompoundsAminesCyclohexanolsHexanolsFatty AlcoholsAlcoholsDimethylaminesMethylaminesLipidsCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Yong In, MD, PhD

    Tthe Catholic Univerisity of Korea Seoul St Mary's hospital

    STUDY CHAIR

Central Study Contacts

Yong In, MD, PhD

CONTACT

8290445228iy1000@catholic.ac.kr

Mansoo Kim, MD

CONTACT

8272333875kms3779@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffesor

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 9, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 9, 2015

Record last verified: 2015-11