Cesarian Section, Epidural Analgesia, Obstetric, Fetal Drug Exposure, Lidocaine Toxicity, Neonatal, Pregnancy, Transplacental Drug Transfer, Urgent Cesarean Delivery
Conditions
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
Category Lucas 1 cesarian section with the timing of birth \< 15 min
Urgent cesarian section within 60 min
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Umbilical arterial and venous plasma lidocaine concentration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Umbilical venous and arterial pH | at birth | Umbilical venous and arterial pH measured by routine cord blood-gas analysis. |
Countries
France
Contacts
Hospices Civils de Lyon