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

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ClinicalTrials.gov Identifier: NCT02600247
Recruitment Status : Unknown
Verified November 2015 by Yong In, The Catholic University of Korea.
Recruitment status was:  Not yet recruiting
First Posted : November 9, 2015
Last Update Posted : November 9, 2015
Sponsor:
Information provided by (Responsible Party):
Yong In, The Catholic University of Korea

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Duloxetine Drug: celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone Not Applicable

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Duloxetine on Pain Relief After Total Knee Arthroplasty in Central Sensitization Patient : A Randomized, Controlled, Double-Blind Trial
Study Start Date : November 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016


Arm Intervention/treatment
Experimental: Duloxetine group

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: Duloxetine

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


Drug: celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone

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


Active Comparator: routine pain control group

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

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 Measures :
  1. Visual pain scale [ Time Frame: Preoperative & postoperative 1, 2, 6, 12 weeks ]

Secondary Outcome Measures :
  1. SF(Short form)- 36 scale(Preoperative and postoperative 6, 12 weeks) [ Time Frame: Preoperative and postoperative 6, 12 weeks ]
  2. Brief pain inventory [ Time Frame: Preoperative and postoperative 1, 6, 12 weeks ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600247


Contacts
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Contact: Yong In, MD, PhD 8290445228 iy1000@catholic.ac.kr
Contact: Mansoo Kim, MD 8272333875 kms3779@naver.com

Sponsors and Collaborators
The Catholic University of Korea
Investigators
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Study Chair: Yong In, MD, PhD Tthe Catholic Univerisity of Korea Seoul St Mary's hospital

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Responsible Party: Yong In, Proffesor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02600247     History of Changes
Other Study ID Numbers: Duloxetine
First Posted: November 9, 2015    Key Record Dates
Last Update Posted: November 9, 2015
Last Verified: November 2015
Keywords provided by Yong In, The Catholic University of Korea:
Total knee arthroplasty
Duloxetine
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Celecoxib
Pregabalin
Oxycodone
Tramadol
Duloxetine Hydrochloride
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors