Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients Undergoing Primary Spinal Tumor Surgery.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- the proportion of patients with chronic postsurgical pain during 3 months after operation
研究概览
简要总结
Chronic postsurgical pain has become one of the most common complications of surgery. The quality of life will be impacted once the postsurgical patients are combined with persistent pain. What's more, the postsurgical pain may increase other adverse outcomes. It's important to find a better way to keep the postsurgical patients away from postoperative pain. Esketamine and pregabalin have become potentially effective drugs on CPSP.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient undergoing elective primary spinal tumor surgery;
- •Ages between 18 and 65 years old;
- •American Society of Anaesthesiology (ASA) status I-III;
- •Signed informed consent.
排除标准
- •Previous adverse reaction to ketamine, s-ketamine or pregabalin;
- •Patients with a diagnosed history of severe chronic pain;
- •Patients with long-term analgesic treatment(gabapentin/opioids/ketamine);
- •Patients with aphasia or inability to cooperate with the pain assessments;
- •Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
- •Patients with a diagnosed history of psychiatric disorder;
- •Patients treated with gabapentin/pregabalin in the last three months;
- •Drug abuse;
- •Body mass index (BMI) > 35 kg/m2 ;
- •Pregnancy or lactation.
研究组 & 干预措施
S-ketamine and pregabalin
干预措施: S-ketamine and pregabalin (Drug)
Normal saline and placebo capsule
干预措施: Normal saline and placebo capsule (Drug)
结局指标
主要结局
the proportion of patients with chronic postsurgical pain during 3 months after operation
时间窗: 3 months postoperatively
The primary outcome was the proportion of patients with CPSP during the 3-month postoperative period (defined as a NRS score ≥ 3).
次要结局
未报告次要终点
研究者
Ruquan Han
Professor
Beijing Tiantan Hospital