NCT03526419已完成不适用
Pharmacokinetics and Breast Milk Excretion of Liposomal Bupivacaine After TAP Block in Patients Undergoing Cesarean Section Delivery
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- milk plasma ratio
研究概览
简要总结
Investigate the pharmacokinetics of Liposomal Bupivacaine and its excretion in breast milk in patients undergoing TAP block after their scheduled C -section delivery
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women >18 year old, scheduled for elective Cesarean delivery and who desire to have a TAP block performed after delivery.
- •American Society of Anesthesiologists physical status I, II, and III
排除标准
- •Patient refusal or inability to cooperate.
- •Allergy, hypersensitivity, intolerance, or contraindication to liposomal bupivacaine.
- •Severely impaired renal or hepatic function (eg, serum creatinine level >2 mg/dL [176.8 µmol/L], blood urea nitrogen level >50 mg/dL [17.9 mmol/L], serum aspartate aminotransferase [AST] level >3 times the upper limit of normal [ULN], or serum alanine aminotransferase [ALT] level >3 times the ULN).
- •Participants at an increased risk for bleeding or with any coagulation disorder (defined as platelet count less than 80, 000 × 103/mm3 or international normalized ratio greater than 1.5) (all contraindications to TAP block).
- •Clinically significant medical disease in either the mother or baby that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other disease in the mother that would constitute a contraindication to participation in the study or cause the mother to be unable to comply with the study requirements.
- •Patient membership in a vulnerable population such as a prisoner, mentally unable to provide direct consent etc.
- •Participant has contraindication to breastfeeding or not planning to breastfeed the first 2-3 days after delivery.
结局指标
主要结局
milk plasma ratio
时间窗: 72 hours
AUC for the milk/plasma drug ratio
次要结局
- AUC of plasma(72 hours)
- AUC of milk(72 hours)
研究者
研究点 (1)
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