Alkalinization of Adrenalized Lidocaine in Extending Epidural Analgesia for Extremely Urgent Cesarean Section During Labor: a Randomized Controlled Trial.

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Epinephrine; Epinephryl borate; Lidocaine; Racepinephrine

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. "code red" 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