Quick Epidural Top-up With Alkalinized Lidocaine for Emergent Caesarean Delivery (NCT05313256) | Clinical Trial Compass
CompletedPhase 2/3
Quick Epidural Top-up With Alkalinized Lidocaine for Emergent Caesarean Delivery
France65 participantsStarted 2022-07-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.