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

Sponsor

The Catholic University of Korea (Other)

Overall Status

Unknown status

CT.gov ID

NCT02600247

Collaborator

(none)

100

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: Duloxetine Drug: celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2015

Anticipated Primary Completion Date :

Nov 1, 2016

Anticipated Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Duloxetine group 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	Drug: Duloxetine 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 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

Arm

Intervention/Treatment

Experimental: Duloxetine group

Drug: Duloxetine

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

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

Drug: celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone

Outcome Measures

Primary Outcome Measures

Visual pain scale [Preoperative & postoperative 1, 2, 6, 12 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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