Randomized Double Blind Comparison of Peri-Operative Standard Analgesia With Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
This study has been designed as a controlled clinical trial to evaluate the efficacy of brief lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when added to conventional opioid therapy following major spine surgery, as well as to evaluate the effects of the lidocaine/ketamine pain protocol on the feasibility of performing routine intraoperative neurophysiology during spine surgery in adults and determine whether this infusion protocol is compatible with intraoperative neurophysiology on spine surgery patients. If one or more of the approaches is confirmed as efficacious and safe, it could have a significant impact on the routine management of postoperative pain in this context.
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
- Double (Participant, Investigator)
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
- •Male and Female >/= 18 years of age Patients undergoing first-time fusion surgery or surgery to revise a prior fusion Able to read, write and speak in English, and able to give informed consent for the study
排除标准
- •Any disease associated with major organ dysfunction renal dysfunction hepatic dysfunction cardiac dysfunction
研究组 & 干预措施
Ketamine
Ketamine infused at 0.25 mg/kg/hour.
干预措施: Ketamine (Drug)
Lidocaine
Lidocaine infused at 0.5 mg/kg/hour.
干预措施: Lidocaine (Drug)
Ketamine and Lidocaine
Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour
干预措施: Lidocaine (Drug)
Ketamine and Lidocaine
Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour
干预措施: Ketamine (Drug)
Placebo
Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
干预措施: Saline (Other)
结局指标
主要结局
Pain Intensity
时间窗: postoperative day 1 - 3
The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe).
次要结局
未报告次要终点
