NCT03865550Unknown不适用
Evaluation of Post Operative Pain Following Primary Total Knee Arthroplasty (TKA) With Intraoperative Subanesthetic Ketamine Administration and Spinal Anesthesia
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Pain as reported on Visual Analog Scale
研究概览
简要总结
The purpose of this study is to establish the effect of sub-anesthetic dosing of ketamine with spinal anesthesia during total knee arthroplasty on post-operative pain and narcotic consumption. We hypothesize that sub-anesthetic ketamine will decrease post-operative pain and narcotic consumption and may secondarily lead to shorter lengths of stay, faster rehabilitation, improved postoperative outcomes and patient satisfaction.
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
- 接受健康志愿者
- 否
入选标准
- •18 - 85 years of age
- •ASA I - IV
- •Undergoing primary unilateral elective total knee arthroplasty with spinal anesthesia
排除标准
- •BMI over 40*
- •Contraindication or allergy to opioid pain medication or ketamine*
- •Daily opioid use for pain control before surgery in excess of systemic morphine equivalent to 10 mg*
- •Ejection fraction (EF) less than 30%
- •Creatinine clearance less than 30 mL/min*
- •History of chronic liver failure
- •Desire for nerve block or general anesthesia
- •Any neurologic or psychiatric disorder (including bipolar disorder, post traumatic stress disorder, schizophrenia)
- •Prior surgery on ipsilateral knee within the last 6 months
- •Alcohol abuse
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Isotonic saline (Drug)
Ketamine
Active Comparator
干预措施: Ketamine Injectable Solution (Drug)
结局指标
主要结局
Pain as reported on Visual Analog Scale
时间窗: Up to 6 weeks post-operatively
VAS pain reported 0-100mm
次要结局
未报告次要终点
研究者
研究点 (1)
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