- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02600247
Effects of Duloxetine on Pain Relief After Total Knee Arthroplasty in Central Sensitization Patient
Effects of Duloxetine on Pain Relief After Total Knee Arthroplasty in Central Sensitization Patient : A Randomized, Controlled, Double-Blind Trial
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mansoo Kim, MD
- Phone Number: 8272333875
- Email: kms3779@naver.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Duloxetine group
Experimental: Duloxetine group
Other Name: cymbalta Drug: Celebrex, Lyrica, Ultracet, Ircodon |
Experimental: Duloxetine group
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 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 |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual pain scale
Time Frame: Preoperative & postoperative 1, 2, 6, 12 weeks
|
Preoperative & postoperative 1, 2, 6, 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SF(Short form)- 36 scale(Preoperative and postoperative 6, 12 weeks)
Time Frame: Preoperative and postoperative 6, 12 weeks
|
Preoperative and postoperative 6, 12 weeks
|
Brief pain inventory
Time Frame: Preoperative and postoperative 1, 6, 12 weeks
|
Preoperative and postoperative 1, 6, 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Yong In, MD, PhD, Tthe Catholic Univerisity of Korea Seoul St Mary's hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Tranquilizing Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Anti-Anxiety Agents
- Anticonvulsants
- Serotonin and Noradrenaline Reuptake Inhibitors
- Calcium-Regulating Hormones and Agents
- Cyclooxygenase 2 Inhibitors
- Calcium Channel Blockers
- Duloxetine Hydrochloride
- Celecoxib
- Acetaminophen
- Pregabalin
- Tramadol
- Oxycodone
Other Study ID Numbers
- Duloxetine
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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