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

14 september 2026 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

95

Kontakter och platser

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Studieorter

      • Lyon, Frankrike
        • Hospices Civils de Lyon

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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
Andra namn:
  • 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
Andra namn:
  • Top up Epidural lidocaine with epinephrine

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Umbilical arterial and venous plasma lidocaine concentration
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Umbilical venous and arterial pH
Tidsram: at birth
Umbilical venous and arterial pH measured by routine cord blood-gas analysis.
at birth

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Interaction between cesarean urgency category and umbilical arterial pH
Tidsram: 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

Samarbetspartners och utredare

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Utredare

  • Huvudutredare: Mikhail DZIADZKO, MD,PhD, Hospices Civils de Lyon

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 oktober 2025

Primärt slutförande (Faktisk)

23 augusti 2026

Avslutad studie (Faktisk)

1 september 2026

Studieregistreringsdatum

Först inskickad

14 september 2026

Först inskickad som uppfyllde QC-kriterierna

14 september 2026

Första postat (Faktisk)

17 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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