Alkalinization of adrenalized lidocaine in extending epidural analgesia for extremely urgent cesarean section during labor: a randomized controlled trial.

Phase 1

• Conditions: epidural analgesia for extremely urgent cesarean; MedDRA version: 20.0Level: SOCClassification code 10036585Term: Pregnancy, puerperium and perinatal conditionsSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2021-006632-67-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-31
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 66

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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 66
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 : lidocaïne
- Persons placed under judicial protection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified