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临床试验/NCT03880916
NCT03880916Unknown不适用

Effects of Duloxetine on Postoperative Wound Complication of Total Knee Arthroplasty(TKA) in Central Sensitization Patient

The Catholic University of Korea0 个研究点目标入组 80 人开始时间: 2019年3月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
80
主要终点
The rates of wound complication

研究概览

简要总结

Postoperative wound complications such as wound dehiscence, skin necrosis, persistent wound drainage, delayed healing, and superficial skin infection could have devastating consequences, leading to arthroplasty failure and patient morbidity requiring additional operations and prolonging hospitalization with substantial burden in cost of care. Recently, interest and research on central sensitization (CS) have been increasing. CS is closely correlated with excessive pain. It has two main characteristics: allodynia and hyperalgesia. CS is an abnormal and intense enhancement of pain mechanism by the central nervous system. One of the mechanisms by which this excessive pain occurs in CS is reduced activation of descending inhibitory pathway associated with deficiency in pathways primarily in response to serotonin and norepinephrine. Serotonin plays an important role in normal wound healing by affecting the formation of neovascularization, inflammatory reactions, fibroblasts and tissue proliferation essential for wound healing. Norepinephrine is also closely related to wound healing by controlling chemotaxis of macrophage essential for normal wound healing. CS is a risk factor for the development of postoperative wound complication after primary Total Knee Arthroplasty (TKA). Preclinical models of central sensitization suggest that duloxetine is effective in the treatment. Investigators will compare the wound complication following TKA of central sensitization patients in duloxetine group (n=40) with those in non-duloxetine group (n=40). 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 wound complication after primary TKA and visual assessment scale at preoperative, postoperative 2 days and 1, 2,6,12 weeks. All participants will receive postoperative pain control after TKA using the same pain control regimen and wound dressing regimen except duloxetine.

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
Quadruple (Participant, Care Provider, 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
  • Central sensitization inventory (CSI)> 40 (Central sensitization patient )

排除标准

  • Rheumatoid arthritis
  • Other inflammatory arthritis
  • Neuropsychiatric patients
  • Allergy or intolerance to study medications
  • Patients with an American society of anesthesiologist (ASA) 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
  1. Phase I (preemptive): 2weeks before operation (30mg for 2weeks)
  2. Phase II (maintenance): 6weeks after operation (30mg for 6 weeks) plus routine pain control (celecoxib, pregabalin, acetaminophen/tramadol, oxycodone)

干预措施: Duloxetine (Drug)

Duloxetine group

Experimental
  1. Phase I (preemptive): 2weeks before operation (30mg for 2weeks)
  2. Phase II (maintenance): 6weeks after operation (30mg for 6 weeks) plus routine pain control (celecoxib, pregabalin, acetaminophen/tramadol, oxycodone)

干预措施: Placebo (Drug)

Placebo group

Placebo Comparator
  1. Phase I (preemptive): 2weeks before operation (Placebo for 2weeks)
  2. Phase II (maintenance): 6weeks after operation (Placebo for 6 weeks) plus routine pain control (celecoxib, pregabalin, acetaminophen/tramadol, oxycodone)

干预措施: Duloxetine (Drug)

Placebo group

Placebo Comparator
  1. Phase I (preemptive): 2weeks before operation (Placebo for 2weeks)
  2. Phase II (maintenance): 6weeks after operation (Placebo for 6 weeks) plus routine pain control (celecoxib, pregabalin, acetaminophen/tramadol, oxycodone)

干预措施: Placebo (Drug)

结局指标

主要结局

The rates of wound complication

时间窗: Change from baseline wound complication at postoperative 2 days, 1 week, 2 weeks, 6 weeks, 12 weeks

wound dehiscence, suture granuloma, prolonged wound ooze occurring after postoperative day 5, significant hematoma formation, or surgical site infection recorded. Post-operative additional interventions included delayed discharge from hospital due to wound problem, additional outpatient clinic visits to examine the surgical wound, local application of antibiotic ointment, superficial wound debridement or suturing in the office, hematoma aspiration, prescription of antibiotics, or reoperation.

Hormone level

时间窗: Change from baseline hormone level at postoperative 2, 6, 12 weeks

Cortisol, Serotonin, Norepinephrine related with Central Sensitization and wound healing

次要结局

  • Pain Visual Analogue Scale (VAS) score(Change from baseline VAS score at postoperative 2 days, 1, 2, 6, 12 weeks)
  • Range of motion of the knee joint(Change from baseline range of motion at postoperative 2 days, 1, 2, 6, 12 weeks)

研究者

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

Yong In

Professor

The Catholic University of Korea

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