Skip to content

Transplacental Neonatal Transfer of Lidocaine During Urgent Caesarean Delivery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07826468
Acronym
Lidocaine TNT
Enrollment
95
Registered
2026-09-17
Start date
2025-10-01
Completion date
2026-09-01
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarian Section, Epidural Analgesia, Obstetric, Fetal Drug Exposure, Lidocaine Toxicity, Neonatal, Pregnancy, Transplacental Drug Transfer, Urgent Cesarean Delivery

Keywords

Lidocaine, Epidural anesthesia, Obstetric anesthesia, Cesarean delivery, Placental transfer, Umbilical cord blood, Fetal acidaemia, Lucas classification, Neonatal exposure

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURECategory Lucas 1 cesarian section

Category Lucas 1 cesarian section with the timing of birth \< 15 min

PROCEDURECategory 3 Lucas Cesarian section

Urgent cesarian section within 60 min

Sponsors

Hôpital de la Croix-Rousse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Umbilical arterial and venous plasma lidocaine concentrationat birthLidocaine 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.

Secondary

MeasureTime frameDescription
Umbilical venous and arterial pHat birthUmbilical venous and arterial pH measured by routine cord blood-gas analysis.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMikhail DZIADZKO, MD,PhD

Hospices Civils de Lyon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026