Ketamine Use in Central Sensitization: a Study Evaluating the Use of Ketamine in Centrally Sensitized Endometriosis Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- change in pain as measured by visual analog scale
研究概览
简要总结
The purpose of this research study is to see if ketamine infusion during surgery can decrease pain after surgery. Ketamine is a medication commonly used as part of anesthesia during surgery and is approved by the US FDA.
Patients will be randomized to either receive standard anesthesia with OR without ketamine. The surgical procedure will be the same regardless of which group patients are randomized to. After surgery, patients will be asked to rate their pain in the post-operative observation unit and at their two-week post-operative visit. No additional visits are required for participation in this study. The investigators estimate the surveys will take approximately 10 minutes to complete.
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 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age range 18-89
- •ASA classification I-III
- •outpatient elective laparoscopy for endometriosis
排除标准
- •known allergy or contraindication to ketamine
- •History of substance use disorder, including alcohol or marijuana use, both current and remote
- •History of severe psychiatric illness, including schizoaffective disorder, bipolar disorder, psychosis, or decompensated psychiatric condition , excluding anxiety and depression
- •Current Intraoperative complications
研究组 & 干预措施
Ketamine
standard general anesthesia with ketamine
干预措施: ketamine (Drug)
结局指标
主要结局
change in pain as measured by visual analog scale
时间窗: approximately post-operative day 0 and 14
A Visual Analog Scale (VAS) is a tool for patients to rate their pain on a 100mm line, where "no pain" is at one end and "worst pain imaginable" is at the other.
次要结局
- Intraoperative opioid consumption as measured by anesthesia charting(Intraoperatively up to 8 hours)
- change in postoperative pain scores measured by numerical rating scale(approximately postoperative day 0 and 14)
- incidence of postoperative nausea/vomiting as measured by patient report(postoperative day 0)
- change in total analgesic consumption post-surgery as measured by chart review and patient report(approximately postoperative day 0, 1 and 14)
- incidence of postoperative delirium as measured by chart review(postoperative day 0)
- change in central sensitization as measured by central sensitization inventory (CSI) score(approximately postoperative day 0 and 14)
研究者
Adi Cosic
Physician
University Hospitals Cleveland Medical Center