Randomized Controlled Trial of Subanesthetic Intravenous Ketamine Infusion in Conjunction With Continuous Epidural Infusion for Treatment of Refractory Complex Regional Pain Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Pain Reduction
研究概览
简要总结
The purpose of this study is to determine whether epidural and ketamine infusions are effective in the treatment of Complex Regional Pain Syndrome (CRPS).
详细描述
Potential patients must clear all study requirements to be enrolled. Study requirements include labwork, psychiatric evaluation, and cardiology evaluation.
Once enrolled, patients will be in one of two groups:
- Receives epidural infusion
- Receives epidural and ketamine infusions
The patient and study staff are blinded.
This study requires multiple visits to Hospital for Special Surgery in New York City over the course of three months and concludes with a final visit after six months. The study will only cover costs associated with the scheduled in-patient and out-patient visits. The study patient will be responsible for all other costs (including travel and hotel accommodations) that he/she may incur for participating in this study.
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
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ketamine Infusion + Epidural Infusion + Booster Infusion
Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three ketamine booster infusions over the course of three months.
干预措施: Ketamine Infusion + Epidural Infusion (Drug)
Ketamine Infusion + Epidural Infusion + Booster Infusion
Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three ketamine booster infusions over the course of three months.
干预措施: Ketamine Booster Infusion (Drug)
Control Group + Epidural Infusion + Booster Infusion
Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three saline booster infusions over the course of three months.
干预措施: Control Group + Epidural infusion (Drug)
Control Group + Epidural Infusion + Booster Infusion
Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.
Outpatient: Patients will receive three saline booster infusions over the course of three months.
干预措施: Control Group Booster Infusion (Drug)
结局指标
主要结局
Pain Reduction
时间窗: 6 months post infusion
Evidence of changes in NRS pain scores between baseline and six months post infusion
次要结局
未报告次要终点