Transplacental Neonatal Transfer of Lidocaine During Urgent Caesarean Delivery: the Lidocaine TNT Prospective Multicentre Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Umbilical arterial and venous plasma lidocaine concentration
研究概览
简要总结
Lidocaine is commonly administered through an existing labor epidural catheter to provide surgical anesthesia for urgent cesarean delivery. Lidocaine crosses the placenta, and fetal exposure may be influenced by maternal dose, the interval between epidural administration and delivery, and fetal acid-base status.
This prospective multicenter observational cohort study evaluated fetal exposure to lidocaine in women undergoing Lucas category 1 or category 3 cesarean delivery after epidural extension with 2% lidocaine and epinephrine. Lidocaine concentrations were measured in paired umbilical arterial and venous plasma samples collected immediately after delivery. The study compared umbilical cord lidocaine concentrations between the two urgency categories and examined their associations with umbilical pH.
详细描述
The Lidocaine TNT study was a prospective observational pharmacokinetic cohort study conducted in two tertiary maternity units of the Hospices Civils de Lyon, France.
Women undergoing Lucas category 1 cesarean delivery, defined by an immediate threat to the life of the woman or fetus, or Lucas category 3 cesarean delivery, defined by the need for early delivery without immediate maternal or fetal compromise, were eligible when surgical anesthesia was obtained by extending a pre-existing labor epidural catheter with 2% lidocaine and epinephrine.
The urgency category was assigned by the attending obstetric team before delivery. In the local color-code system, Lucas category 1 corresponded to red-code cesarean delivery, with a target decision-to-delivery interval below 15 minutes, and Lucas category 3 corresponded to green-code cesarean delivery, with a target interval below 60 minutes.
Epidural extension was performed according to routine clinical practice using lidocaine 2% with epinephrine 1:200,000. The lidocaine dose, timing of administration, use of adjuncts, and need for additional anesthetic supplementation were determined by the attending anesthesia team and were not assigned by the study protocol.
Paired umbilical arterial and venous blood samples were collected immediately after delivery in blood-gas syringes containing dry heparin. After routine blood-gas analysis, residual plasma was stored and subsequently analyzed using liquid chromatography-tandem mass spectrometry.
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
- 否
入选标准
- •Woman aged 18 years or older. Lucas category 1 or category 3 cesarean delivery. Pre-existing labor epidural catheter. Surgical anesthesia obtained by epidural extension using lidocaine 2% with epinephrine.
- •Participant informed about the secondary use of routinely collected data and residual biological samples.
- •Absence of opposition to participation in accordance with French regulations.
排除标准
- •Lucas category 2 cesarean delivery. Elective or prophylactic cesarean delivery not requiring urgent fetal extraction.
- •Absence of a functioning epidural catheter. Absence of an objective sensory block or effective labor analgesia suggesting epidural catheter failure.
- •Suspected intrathecal catheter migration or unintentional dural puncture. Cesarean delivery performed under general anesthesia alone. Cesarean delivery performed under spinal anesthesia alone.
研究组 & 干预措施
Lucas category 1 cesarean delivery
Women undergoing cesarean delivery because of an immediate threat to the life of the woman or fetus. The locally targeted decision-to-delivery interval was less than 15 minutes.
干预措施: Category Lucas 1 cesarian section (Procedure)
Lucas category 3 cesarean delivery
Women requiring early cesarean delivery without immediate maternal or fetal compromise. The locally targeted decision-to-delivery interval was less than 60 minutes.
干预措施: Category 3 Lucas Cesarian section (Procedure)
结局指标
主要结局
Umbilical arterial and venous plasma lidocaine concentration
时间窗: at birth
Lidocaine concentration measured in plasma obtained from an umbilical venous and arterial blood sample using liquid chromatography-tandem mass spectrometry. Concentrations are expressed in ng/mL and compared between Lucas category 1 and category 3 cesarean deliveries.
次要结局
- Umbilical venous and arterial pH(at birth)
研究者
Mikhail Dziadzko, MD, PhD
Senior Physician
Hôpital de la Croix-Rousse