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临床试验/NCT02307305
NCT02307305Unknown2 期

Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty?

Hanyang University Seoul Hospital1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
168
试验地点
1
主要终点
neuropathic pain(the self assessed-Leeds Assessment of Neuropathic Symptoms and Signs pain scale, S-LANSS)

研究概览

简要总结

Range from 24% to 44%, with a prevalence of neuropathic-type pain from 6% to 20%-cause impairment in quality of life and functional capacity after total knee arthroplasty(TKA). Duloxetine (cymbalta) is a selective serotonin and nor-epinephrine reuptake inhibitor shown to be effective in treating chronic pain. Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Its effects on depression and anxiety symptoms, as well as its effect on pain perception, may be due to increasing the activity of serotonin and norepinephrine in the central nervous system. Approved for the acute and maintenance treatment of major depressive disorder, the acute treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and the management of fibromyalgia, all in adults (18+).

Investigators will compare the neuropathic pain following TKA in duloxetine group (n=84) with those in non-duloxetine group (n=84). Investigators will classify the participants in to 2 groups (duloxetine and non-duloxetine group) randomly, and primarily evaluate the degree of neuropathic pain using the S-LANSS pain scale (preoperatively and postoperatively 3 and 6 months). 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, Patient controlled analgesia (postoperation 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN)

Drug generic names: celecoxib (celebrex), naproxen/esomeprazole (vimovo), acetaminophen/tramadol (ultracet ER), oxycodone/naloxone (targin)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Osteoarthritis of knee requiring TKA

排除标准

  • Rheumatoid arthritis
  • Other inflammatory arthritis
  • Neuropsychiatric patients
  • Hepatic insufficiency
  • Renal insufficiency
  • Patients older than 75
  • Allergy or intolerance to study medications
  • Patients with an ASA 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)

研究组 & 干预措施

Duloxetin group

Experimental
  1. Phase I (preemptive): 2 hour before surgery (30mg for 1 day)
  2. Phase II (titration): POD#1~6 (30mg for another 6 days)
  3. Phase III (maintenance): POD#7~13(60mg for 7 days)
  4. Phase IV (tapering-1): POD#14~20 (30mg for 7 days)
  5. Phase V (tapering-2): POD#21~27 (30mg another every day for 7 days)

plus routine pain control (celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone)

干预措施: Duloxetine (Drug)

Duloxetin group

Experimental
  1. Phase I (preemptive): 2 hour before surgery (30mg for 1 day)
  2. Phase II (titration): POD#1~6 (30mg for another 6 days)
  3. Phase III (maintenance): POD#7~13(60mg for 7 days)
  4. Phase IV (tapering-1): POD#14~20 (30mg for 7 days)
  5. Phase V (tapering-2): POD#21~27 (30mg another every day for 7 days)

plus routine pain control (celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone)

干预措施: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone (Drug)

routine pain control group

Active Comparator

Preemptive analgesia : celebrex, Patient controlled analgesia (postop. 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN)

Other name of drugs: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone

干预措施: celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone (Drug)

结局指标

主要结局

neuropathic pain(the self assessed-Leeds Assessment of Neuropathic Symptoms and Signs pain scale, S-LANSS)

时间窗: 6 months

次要结局

  • Numeric rating scale for pain (NRS)(6 months)
  • American Knee Society knee and function score(6 months)
  • Western Ontario and McMaster University Arthritis Index (WOMAC)(6 months)
  • Geriatric depression scale-short form(6 months)

研究者

发起方
Hanyang University Seoul Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

JIN KYU LEE

Assistant professor

Hanyang University Seoul Hospital

研究点 (1)

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