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Effects of Duloxetine on Pain Relief After Total Knee Arthroplasty in Central Sensitization Patient

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Duloxetine
celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Total knee arthroplasty, Duloxetine

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Duloxetine group

    routine pain control group

    Arm Description

    Experimental: Duloxetine group Phase I (preemptive): 1day before operation (30mg for 1 day) 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

    Outcomes

    Primary Outcome Measures

    Visual pain scale

    Secondary Outcome Measures

    SF(Short form)- 36 scale(Preoperative and postoperative 6, 12 weeks)
    Brief pain inventory

    Full Information

    First Posted
    November 5, 2015
    Last Updated
    November 6, 2015
    Sponsor
    The Catholic University of Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02600247
    Brief Title
    Effects of Duloxetine on Pain Relief After Total Knee Arthroplasty in Central Sensitization Patient
    Official Title
    Effects of Duloxetine on Pain Relief After Total Knee Arthroplasty in Central Sensitization Patient : A Randomized, Controlled, Double-Blind Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    November 2016 (Anticipated)
    Study Completion Date
    November 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Catholic University of Korea

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Both groups of participants will receive pain control regimens as follows: Preemptive analgesia : celebrex celecoxib, Lyrica Pregabalin, Patient controlled analgesia (postoperation 28 hours), During admission : celebrex 200mg#1, Ircodon 5mg 2Tablets#2, Ultracet 2T#2 (Postoperation 1 week) Discharge medication: celebrex 200mg 1Capsule#1 x 5 weeks, Ultracet 2T#2 x 1 week Drug generic names: celecoxib (celebrex), Pregabalin (Lyrica), acetaminophen/tramadol (ultracet ER), oxycodone (Ircodon)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis
    Keywords
    Total knee arthroplasty, Duloxetine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Duloxetine group
    Arm Type
    Experimental
    Arm Description
    Experimental: Duloxetine group Phase I (preemptive): 1day before operation (30mg for 1 day) 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
    Arm Title
    routine pain control group
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Duloxetine
    Intervention Description
    Experimental: Duloxetine group Phase I (preemptive): 1day before operation (30mg for 1 day) 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
    Intervention Type
    Drug
    Intervention Name(s)
    celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Visual pain scale
    Time Frame
    Preoperative & postoperative 1, 2, 6, 12 weeks
    Secondary Outcome Measure Information:
    Title
    SF(Short form)- 36 scale(Preoperative and postoperative 6, 12 weeks)
    Time Frame
    Preoperative and postoperative 6, 12 weeks
    Title
    Brief pain inventory
    Time Frame
    Preoperative and postoperative 1, 6, 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients for total knee arthroplasty having medicare insurance CSI(Central sensitization inventory)> 40 (Central sensitization patient ) Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yong In, MD, PhD
    Phone
    8290445228
    Email
    iy1000@catholic.ac.kr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mansoo Kim, MD
    Phone
    8272333875
    Email
    kms3779@naver.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yong In, MD, PhD
    Organizational Affiliation
    Tthe Catholic Univerisity of Korea Seoul St Mary's hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Duloxetine on Pain Relief After Total Knee Arthroplasty in Central Sensitization Patient

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