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Completed
NCT05313256
Quick Epidural Top-up With Alkalinized Lidocaine for Emergent Caesarean Delivery
Conditions: Obstetric Labor Complications
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 65
Sponsor: University Hospital, Bordeaux
Location: CH de la Côte Basque Bayonne
Summary
Prospective randomized study comparing the use of lidocaine 2% with epinephrine buffered with sodium bicarbonate and lidocaine 2% with epinephrine as epidural top-up for extremely urgent cesarean section during labour.
Eligibility Criteria
Inclusion Criteria:
* Adult patients, affiliated to social security
* Informed consent signed by the participant and the investigating physician at the latest after the therapeutic intervention
* Initial indication for vaginal delivery
* Benefiting from emergency caesarean section during labour for fetal extraction with a maximum 15-minute decision-to-delivery delay (i.e. extremely urgent caesarean section)
Exclusion Criteria:
* Opposition to participation in research before delivery
* Refusal or impossibility of informed consent
* Lack of understanding or significant language barrier
* Initial indication for general anaesthesia defined by the following situations: non-functional epidural analgesia, altered consciousness, eclampsia, suspicion of amniotic embolism, confirmed or suspected severe haemorrhage occurring before birth
* Contraindication to the use of the products defined in the protocol : adrenalized lidocaine ; sodium bicarbonate.
* Persons placed under judicial protection
Source: ClinicalTrials.gov (NCT05313256). StuddyBuddy aggregates publicly available trial information.