Transplacental Neonatal Transfer of Lidocaine During Urgent Caesarean Delivery

NCT07826468 | Completed

• 1 other identifier: AGORA 24-5532
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarian Section; Lidocaine Toxicity; Neonatal and Perinatal Conditions; Epidural Anesthesia

Keywords

Epidural anesthesia; Cesarean delivery; Placental transfer; Umbilical cord blood; Foetal Acidosis

Outcome Measures

Primary Outcomes (1)

• Umbilical arterial and venous plasma lidocaine concentration

  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

Secondary Outcomes (1)

• Umbilical venous and arterial pH

  at birth

Other Outcomes (1)

• Interaction between cesarean urgency category and umbilical arterial pH

  at birth

Study Arms (2)

Lucas category 1 cesarean delivery

Women undergoing cesarean delivery because of an immediate threat to the life of the woman or fetus were eligible. The locally targeted decision-to-delivery interval was less than 15 minutes.

Procedure: Category Lucas 1 cesarian section

Lucas category 3 cesarean delivery

Women requiring early cesarean delivery without immediate maternal or fetal compromise. The local target decision-to-delivery interval was less than 60 minutes.

Procedure: Category 3 Lucas Cesarian section

Interventions

Category Lucas 1 cesarian section PROCEDURE

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

Also known as: Topup Epidural lidocaine with epinephrine

Lucas category 1 cesarean delivery

Category 3 Lucas Cesarian section PROCEDURE

Urgent cesarian section within 60 min

Also known as: Top up Epidural lidocaine with epinephrine

Lucas category 3 cesarean delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Participant informed about the secondary use of routinely collected data and residual biological samples.
• Absence of opposition to participation in accordance with French regulations.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hôpital de la Croix-Rousse: lead

Study Sites (1)

Hospices Civils de Lyon

Lyon, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Residual umbilical arterial and venous plasma obtained after routine cord blood-gas analysis was stored for subsequent measurement of lidocaine concentrations by liquid chromatography-tandem mass spectrometry.

MeSH Terms

Interventions

Epinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Mikhail DZIADZKO, MD,PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2025
• Primary Completion: August 23, 2026
• Study Completion: September 1, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)