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How much lidocaine reaches a newborn during an urgent C-Section?

NCT ID NCT07826468

Knowledge-focused Sponsor: Hôpital de la Croix-Rousse Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Lidocaine is often injected through an existing epidural catheter to numb women for urgent cesarean delivery, and the drug can cross the placenta to the baby. Researchers at multiple hospitals are measuring lidocaine levels in paired umbilical cord blood samples collected right after birth. The study compares two urgency categories, delivery within 15 minutes and delivery within 60 minutes, and checks whether cord blood acidity relates to drug levels. The goal is to understand fetal exposure and help doctors refine epidural dosing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lidocaine with epinephrine given through an epidural catheter
What this could lead to
If researchers map how lidocaine moves across the placenta, doctors could refine epidural dosing for urgent cesarean deliveries and reduce newborn drug exposure.
What could go wrong
This observational study measures drug levels in cord blood but cannot prove what dose or timing is safest. Results from 95 deliveries may not apply to all hospitals or patient groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

95 people

The number who actually took part.

Started

Oct 2025

Finished

Sep 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

local anesthetic poisoning

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cesarian section Epidural analgesia, obstetric Fetal drug exposure Lidocaine toxicity Neonatal Pregnancy Transplacental drug transfer Urgent cesarean delivery

Contacts and locations

Locations

  • Hospices Civils de Lyon

    Lyon, France

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