Second Affiliated Hospital Zhejiang University School of Medicine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- the mechanical pain threshold around the incision
研究概览
简要总结
Postoperative hyperalgesia (POH) is a paradoxical clinical state of increased sensation of pain or increased sensitivity to non-painful stimuli at the site of surgery or at a surrounding area that was not directly injured. Opioid-induced hyperalgesia (OIH) and nociceptive-induced hyperalgesia (NIH) are the two main causes of POH.N-methyl-D-aspartate receptor (NMDAR) activation plays a central role in the development of POH.S-ketamine，which is a NMDA-receptor antagonist,has been on the market in china since 2019.The aim of this study is to evaluate the effects of S-ketamine on POH and chronic postoperative pain after video-assisted thoracic surgery.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status class I-III.
- •elective single-port video-assisted thoracic surgery under general
排除标准
- •a history of thoracic surgery
- •a history of chronic pain
- •ongoing pain treatment
- •opioid drug or alcohol abuse
- •a history of allergy to anesthetics
- •obesity (body mass index [BMI] >30 kg/m2 )
- •pregnancy
- •psychiatric disorders
- •neurological disease
- •severe diabetes
- •renal or hepatic insufficiency
- •uncontrolled hypertension, or arrhythmia
研究组 & 干预措施
S-ketamine
a 0.25 mg/kg bolus and 0.125 mg/kg/h via intravenous infusion during surgery
干预措施: S-ketamine (Drug)
Saline
a 0.25 mg/kg bolus and 0.125 mg/kg/h via intravenous infusion during surgery
干预措施: saline (Drug)
结局指标
主要结局
the mechanical pain threshold around the incision
时间窗: Day1 after surgery
the mechanical pain threshold was assessed by using 10 calibrated (4-300 g mm-2 ) hand-held Von Frey filaments (North Coast Medical Inc.USA)around the skin incision.The per pain threshold was defined as the smallest force (g mm-2 ) necessary to bend a von Frey hair, and perceived by the patient as three consecutive painful stimuli with approximately 10 s elapsing between two successive stimuli. The mechanical pain threshold was recorded as the mean of 6 measurements at 2 cm vertically above and below the middle and bilateral edges of the incision.
次要结局
- the mechanical pain threshold on the forearm(the day before surgery)
- the mechanical pain threshold(Day2 after surgery)
- the mechanical pain threshold around the incision(Day2 after surgery)
- postoperative pain scores(up to day2 after surgery)
- Anxiety scale scores(up to day2 after surgery)
- Depression scale scores(up to day2 after surgery)
- The hyperalgesic area around the incision(up to day2 after surgery)