此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Transplacental Neonatal Transfer of Lidocaine During Urgent Caesarean Delivery (Lidocaine TNT)

2026年9月14日 更新者:Mikhail Dziadzko, MD, PhD、Hôpital de la Croix-Rousse

Transplacental Neonatal Transfer of Lidocaine During Urgent Caesarean Delivery: the Lidocaine TNT Prospective Multicentre Cohort Study

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.

研究概览

详细说明

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.

The primary objective was to compare umbilical arterial and venous plasma lidocaine concentrations between Lucas category 1 and category 3 cesarean deliveries. Secondary objectives were to examine the associations between umbilical pH and the corresponding lidocaine concentrations and to assess whether the relationship between arterial pH and arterial lidocaine concentration differed according to cesarean urgency category.

Arterial and venous lidocaine concentrations were analyzed separately after natural-log transformation. Bayesian Gaussian linear regression models included Lucas category, the corresponding umbilical pH, birth weight, gestational age, and maternal epidural lidocaine dose. A secondary model included an interaction between Lucas category and umbilical arterial pH. Complete-case analyses were performed without imputation of missing data.

研究类型

观察性的

注册 (实际的)

95

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Lyon、法国
        • Hospices Civils de Lyon

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Pregnant women with a functioning labour epidural who required an unplanned Lucas category 1 or category 3 Caesarean delivery and received epidural lidocaine for surgical anaesthesia. Fetal exposure was assessed using paired umbilical arterial and venous blood samples collected at delivery.

描述

Inclusion criteria 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.

Exclusion criteria 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.
Category Lucas 1 cesarian section with the timing of birth < 15 min
其他名称:
  • Topup Epidural lidocaine with epinephrine
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.
Urgent cesarian section within 60 min
其他名称:
  • Top up Epidural lidocaine with epinephrine

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Umbilical arterial and venous plasma lidocaine concentration
大体时间: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.
at birth

次要结果测量

结果测量
措施说明
大体时间
Umbilical venous and arterial pH
大体时间:at birth
Umbilical venous and arterial pH measured by routine cord blood-gas analysis.
at birth

其他结果措施

结果测量
措施说明
大体时间
Interaction between cesarean urgency category and umbilical arterial pH
大体时间:at birth
Interaction coefficient between Lucas urgency category and umbilical arterial pH in an adjusted Bayesian Gaussian regression model of natural-log-transformed umbilical arterial lidocaine concentration. This analysis assesses whether the arterial pH-lidocaine concentration relationship differs between Lucas category 1 and category 3 cesarean deliveries.
at birth

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mikhail DZIADZKO, MD,PhD、Hospices Civils de Lyon

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年10月1日

初级完成 (实际的)

2026年8月23日

研究完成 (实际的)

2026年9月1日

研究注册日期

首次提交

2026年9月14日

首先提交符合 QC 标准的

2026年9月14日

首次发布 (实际的)

2026年9月17日

研究记录更新

最后更新发布 (实际的)

2026年9月17日

上次提交的符合 QC 标准的更新

2026年9月14日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

the data are property of the Hospices Civils de Lyon, no individual participant data can be shared according to French regulation

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅