Cesarian SectionLidocaine TNTNCT07826468
Transplacental Neonatal Transfer of Lidocaine During Urgent Caesarean Delivery
An observational study of Cesarian Section and Neonatal and Perinatal Conditions, run by Hôpital de la Croix-Rousse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarian Section, Neonatal and Perinatal Conditions, Epidural Anesthesia
- What is being tested?
- Category Lucas 1 cesarian section and Category 3 Lucas Cesarian section
- Type of treatment
- Surgery or procedure
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cesarian Section, Neonatal and Perinatal Conditions, Epidural Anesthesia, Lidocaine Toxicity
- Being tested
- Category Lucas 1 cesarian section, Category 3 Lucas Cesarian section
- Keywords
- Epidural anesthesia, Cesarean delivery, Placental transfer, Umbilical cord blood, Foetal Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Category Lucas 1 cesarian sectionProcedure or surgery
Also called Topup Epidural lidocaine with epinephrine
Category Lucas 1 cesarian section with the timing of birth < 15 min
Category 3 Lucas Cesarian sectionProcedure or surgery
Also called Top up Epidural lidocaine with epinephrine
Urgent cesarian section within 60 min
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Category 3 Lucas Cesarian section |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at birth
Secondary outcomes (1)
Umbilical venous and arterial pH
Umbilical venous and arterial pH measured by routine cord blood-gas analysis.
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Oct 2025
- Primary completion23 Aug 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarian SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital de la Croix-Rousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikhail Dziadzko, MD, PhD, Hôpital de la Croix-Rousse
- Investigators
- Mikhail DZIADZKO, MD,PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826468
- Sponsor's protocol ID
- AGORA 24-5532
- Acronym
- Lidocaine TNT
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data are property of the Hospices Civils de Lyon, no individual participant data can be shared according to French regulation
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplacental Neonatal Transfer of Lidocaine During Urgent Caesarean Delivery: the Lidocaine TNT Prospective Multicentre Cohort Study
- ClinicalTrials.gov ID
- NCT07826468
- Acronym / sponsor ID
- Lidocaine TNT / AGORA 24-5532
- Conditions
- Cesarian Section, Neonatal and Perinatal Conditions, Epidural Anesthesia, Lidocaine Toxicity
- Keywords
- Epidural anesthesia, Cesarean delivery, Placental transfer, Umbilical cord blood, Foetal Acidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Hôpital de la Croix-RousseUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 23 Aug 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lucas category 1 cesarean delivery | – | Procedure: Category Lucas 1 cesarian sectionWomen 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. |
| Lucas category 3 cesarean delivery | – | Procedure: Category 3 Lucas Cesarian sectionWomen requiring early cesarean delivery without immediate maternal or fetal compromise. The local target decision-to-delivery interval was less than 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Category Lucas 1 cesarian sectionAlso: Topup Epidural lidocaine with epinephrineCategory Lucas 1 cesarian section with the timing of birth < 15 min | Procedure or surgery | Lucas category 1 cesarean delivery |
| Category 3 Lucas Cesarian sectionAlso: Top up Epidural lidocaine with epinephrineUrgent cesarian section within 60 min | Procedure or surgery | Lucas category 3 cesarean delivery |
Primary outcome
Umbilical arterial and venous plasma lidocaine concentration
Time frame: 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.
1 secondary outcome
Umbilical venous and arterial pH
Time frame: at birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. the data are property of the Hospices Civils de Lyon, no individual participant data can be shared according to French regulation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail DZIADZKO, MD,PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarian Section and Neonatal and Perinatal Conditions, run by Hôpital de la Croix-Rousse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Umbilical arterial and venous plasma lidocaine concentration (time frame: at birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.