Effects of Prophylactic Administration of Ketamine on Acute and Chronic Pain After Thoracotomy for Lung Cancer, a Double Blind Randomised Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in acute pain
研究概览
简要总结
Chronic Pain, especially neuropathic pain, are adverse events after posterolateral thoracotomy for lung resection. The continuous application of ketamine may have a prophylactic effect and helps to prevent chronic pain. The investigators record the incidence and severity of acute pain and neuropathic pain during a seven day period after thoracotomy as well as the incidence of chronic pain and neuropathic pain after one and three month period. Parallel Group design, comparing one Group with a continuous application (24 hours) of ketamine against a Placebo Group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •posterolateral thoracotomy for lung parenchyma resection
- •informed consent
- •ASA (American Society of Anesthesiologists) Status I-III
排除标准
- •history of chronic pain
- •history of neuropathic pain
- •pregnancy or breastfeeding
- •participation in another trial
- •hypersensitivity for ketamine
- •medication with can influence neuropathic pain (gabapentin, clonazepam)
- •history of neurological or behavioral illness
- •history of alcohol abuse
- •history of chemotherapy or radiation
- •opioid medication
研究组 & 干预措施
Ketamine
The patients in this Group underwent General anaesthesia with total intravenous anaesthesia containing remifentanil (0,02-0,04 mg/kg ideal Body weight), propofol (4-6 mg/kg ideal Body weight) and atracurium.
Ketamine 0,2 mg/kg ideal Body weight per hour for 24 hours.
干预措施: Ketamine (Drug)
Placebo
The patients in this Group underwent General anaesthesia with total intravenous anaesthesia containing remifentanil (0,02-0,04 mg/kg ideal Body weight), propofol (4-6 mg/kg ideal Body weight) and atracurium.
Placebo (normal Saline) for 24 hours.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in acute pain
时间窗: 7 days after Operation
The incidence and severity of pain will be measured using a numeric analog scale (NAS) once a day for a period of seven days after Operation.
acute neuropathic pain
时间窗: 7 days after operation
The incidence of neuropathic pain will be measured using the LANSS Pain Scale (Leeds assessment of neuropathic symptoms and signs) three and seven days after operation
Change in perioperative opioid consumption
时间窗: seven days after operation
The patients consumption of opioids is recorded once a day for a period of 7 days after operation.
次要结局
- Chronic Neuropathic pain(one month after operation)
- recovery time(eye opening after stopping anesthesia in minutes)
- Change in chronic Pain(one and three month after operation)
- Chronic Neuropathic Pain(three month after operation)