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临床试验/NCT02600247
NCT02600247Unknown不适用

Effects of Duloxetine on Pain Relief After Total Knee Arthroplasty in Central Sensitization Patient : A Randomized, Controlled, Double-Blind Trial

The Catholic University of Korea0 个研究点目标入组 100 人开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
主要终点
Visual pain scale

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Duloxetine (Drug)

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

干预措施: celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone (Drug)

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

干预措施: celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone (Drug)

结局指标

主要结局

Visual pain scale

时间窗: Preoperative & postoperative 1, 2, 6, 12 weeks

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yong In

Proffesor

The Catholic University of Korea

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