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临床试验/NCT01983020
NCT01983020已完成3 期

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

Beth Israel Medical Center1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Ketamine infused at 0.25 mg/kg/hour.

干预措施: Ketamine (Drug)

Lidocaine

Experimental

Lidocaine infused at 0.5 mg/kg/hour.

干预措施: Lidocaine (Drug)

Ketamine and Lidocaine

Experimental

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

Experimental

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 Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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