Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- the proportion of patients with acute moderate-to-severe postsurgical pain during 48h after operation
研究概览
简要总结
Postsurgical pain is now known to be one of the most common and difficult-to-treat complications of surgery. severe postoperative pain can significantly impair patients' quality of life, social functioning and contribute to excessive health care expenditures. It is worth noting that acute postoperative pain may play a vital role in central sensitization and up-regulation of pain receptors, even factors implicated in the development of CPSP. According to previous studies, the incidence of postoperative pain among patients undergoing spinal surgery was nearly 80%. At the same time, perioperative pain management of patients undergoing spinal surgery has not been clearly. For the past few years, pregabalin and esketamine are becoming important roles in perioperative pain management, lots of studies have shown that these two analgesics might relieve postoperative pain. The aim of this study was to evaluate the acute analgesic effects of esketamine and pregabalin in combination after spinal cord neoplasms resection, so as to find a better way to help the patients undergoing spinal surgery keep away from the acute perioperative pain.
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
- 否
入选标准
- •Patient undergoing elective spinal cord neoplasms resection;
- •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 acute moderate-to-severe postsurgical pain during 48h after operation
时间窗: 48 hours after operation
The primary outcome was the proportion of patients with acute moderate-to-severe postsurgical pain during the 48-h postoperative period (defined as a VAS score ≥ 40 mm).
次要结局
未报告次要终点
研究者
Ruquan Han
Professor
Beijing Tiantan Hospital