Status:
COMPLETED
Quick Epidural Top-up with Alkalinized Lidocaine for Emergent Caesarean Delivery
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Obstetric Labor Complications
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief 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 sect...
Detailed Description
General anesthesia in pregnant women remains burdened by a significant maternal-fetal morbidity and mortality. An increased risk of orotracheal intubation difficulty, gastric inhalation syndrome and n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT05313256
Start Date
July 14 2022
End Date
July 8 2024
Last Update
November 15 2024
Active Locations (2)
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1
CH de la Côte Basque
Bayonne, France
2
CHU de Bordeaux
Bordeaux, France