Relationship Between Central Sensitization and Alteration of Circulating Neurosteroid Following Bilateral Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- The profiles of cortisol in the saliva
研究概览
简要总结
For patients who underwent two-stage replacement of both knee joints (one knee surgery - one week term- the other knee surgery), postoperative pain and analgesic usage with patient-controlled analgesia (PCA) increased at the second stage, which suggests that central sensitization occurs within a short period (one week) in patients who undergo total knee arthroplasty (TKA). Neurosteroids act on NMDA and AMPA receptors, GABAa receptors, and voltage-dependent Ca2+ or K+ channels of sensory neurons to increase invasive or neuropathic pain and, conversely, to exhibit analgesic and anticonvulsant effects. These actions mean that the neurosteroid acts as an endogenous regulator of pain control and central sensitization. The purpose of this study is to confirm that the hypothalamus-pituitary-adrenal (HPA) axis, which is the main body of endocrine neurosteroid, is associated with increased pain sensitivity after TKA. The concentrations of cortisol and dehydroepiandrosterone (DHEA) in the saliva of patients who undergo two-staged bilateral knee replacement surgery (one knee surgery - one week term- the other knee surgery) will be measured at each stage and analyzed for correlation between concentration-related changes of HPA and postoperative knee pain variations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Two-staged bilateral total knee arthroplasty (one knee - one week - the other knee)
- •American Society of Anesthesiologists (ASA) class I, II
- •Postmenopausal women aged under 71
排除标准
- •Patients who have used analgesics before surgery, such as chronic pain patients
- •≥ ASA class III, including patients with renal impairment or symptomatic cardiovascular disease
- •Patients who refuse to participate in the study or from whom receive informed consent cannot be received.
结局指标
主要结局
The profiles of cortisol in the saliva
时间窗: From the evening (9PM) before the operation day to the morning (60 minutes after the wake-up) of the operation day, for each stage of the operation.
The cortisol concentrations in the saliva, at the evening before the operation (21:00-22:00), just after wake-up in the morning of operation day, and 30 and 60 minutes after the wake-up.
The profiles of DHEA in the saliva
时间窗: From the evening (9PM) before the operation day to the morning (60 minutes after the wake-up) of the operation day, for each stage of the operation.
The DHEA concentrations in the saliva, at the evening before the operation (21:00-22:00), just after wake-up in the morning of operation day, and 30 and 60 minutes after the wake-up.
Post operative knee pain
时间窗: At 24h and 48h after the operation, for each stage of the operation.
At rest and at maximum knee flexion, visual analogue scale (VAS) score of knee pain;
次要结局
- Antiemetic usage(At 24h and 48h after the operation, for each stage of the operation.)
- CARauc(At the morning of operation day, for each stage of the operation)
- Analgesic usage (PCA)(At 24h and 48h after the operation, for each stage of the operation.)
- Analgesic usage (rescue)(At 24h and 48h after the operation, for each stage of the operation.)
- Diurnal slope(From the evening (9PM) before the operation day to the morning (60 minutes after the wake-up) of the operation day, for each stage of the operation.)
- Daucawk(At the morning of operation day, for each stage of the operation)
- CARi(At the morning of operation day, for each stage of the operation)
研究者
Jin-Woo Park
Assistant Professor
Seoul National University Bundang Hospital