Transplacental Neonatal Transfer of Lidocaine During Urgent Caesarean Delivery (Lidocaine TNT)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Lyon, Frankrig
- Hospices Civils de Lyon
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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
Andre navne:
|
|
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
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Umbilical arterial and venous plasma lidocaine concentration
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Umbilical venous and arterial pH
Tidsramme: at birth
|
Umbilical venous and arterial pH measured by routine cord blood-gas analysis.
|
at birth
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Interaction between cesarean urgency category and umbilical arterial pH
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Mikhail DZIADZKO, MD,PhD, Hospices Civils de Lyon
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AGORA 24-5532
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .