Quick Epidural Top-up With Alkalinized Lidocaine for Emergent Caesarean Delivery

Obstetric Labor Complications Clinical Trial

— QETAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05313256
• Other study ID #: CHUBX 2021/36
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 14, 2022
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Bordeaux
• Contact: Thomas DENIER D'APRIGNY
• Phone: 0556795679
• Email: thomas.denier-daprigny[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 neonatal respiratory depression is described.

The rate of epidural analgesia during labor is about 85% in France. In addition to the comfort provided, epidural analgesia allows emergency Caesarean sections to be performed by converting epidural analgesia to epidural anesthesia, a technique known as "epidural extension" or "epidural top-up". The effectiveness and the time necessary to obtain this surgical anesthesia depends on the protocols used and determines the possibility of performing fetal extractions, even the most urgent ones, without resorting to general anesthesia.

We define an extremely urgent cesarean delivery as a delivery required in the event of an immediate threat to maternal or fetal vital prognosis, with a target of less than 15 minutes between the extraction decision time and birth.

In France, the latest recommendations date from 2007 and recommend the practice of epidural extension with 15 to 20 ml of 2% adrenaline lidocaine. With this technique, surgical anesthesia is typically obtained within 10 to 15 minutes. This time remains too long in certain obstetrical emergency situations, notably extremely urgent cesarean sections, which require frequent recourse to general anesthesia to compensate for this length of nerve block installation.

The alkalinization of local anesthetics with sodium bicarbonate has been experimentally studied since the 1970s and makes it possible to accelerate the time of action of local anesthetics. Alkalinization of local anesthetics is practiced in 35% of epidural extensions in Denmark and 12% of epidural extensions in the United Kingdom.

Since 2016, this technique has been used in the anesthesia departments of maternity units of Bayonne and Bordeaux hospitals. In the former, a retrospective study of 51 cases from January 2019 to July 2019 showed a decrease of more than 80% in the rate of recourse to general anesthesia in extremely urgent caesarean sections (4/4 vs 0/7) and a 50% decrease in the time required to obtain adequate epidural anesthesia (5 min vs 10 min).

The main objective of the current prospective study is to prospectively confirm the decrease in the use of general anesthesia in extremely urgent cesarean sections.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor Complications

Intervention

Drug:
• Lidocaine epinephrine buffered with sodium bicarbonate
When an extremely urgent fetal extraction by caesarean section is decided, the patient will be randomized. An epidural top-up will then be performed with Lidocaine epinephrine buffered with sodium bicarbonate.
• Lidocaine epinephrine
When an extremely urgent fetal extraction by caesarean section is decided, the patient will be randomized. An epidural top-up will then be performed with Lidocaine epinephrine.

Locations

Country	Name	City	State
France	CH de la Côte Basque	Bayonne
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resort to general anaesthesia	Resort to general anaesthesia for insufficient analgesia after epidural extension for extremely urgent caesarean section.	15 minutes after inclusion
Secondary	Delay between fetal extraction decision and birth	Minutes between the decision to extract the fetus by the obstetrical team and the clamping of the umbilical cord	Between inclusion and birth
Secondary	Delay between fetal extraction decision and incision	Minutes between the decision to extract the fetus by the obstetrical team and the surgical incision	Between inclusion and cesarean section
Secondary	Maternal complications	Maternal complications after epidural top-up, including nausea-vomiting in the peroperative and postoperative period, desaturation episode, difficult orotracheal intubation, bronchial inhalation syndrome, hypotensive episode before fetal extraction, extended sensory or motor block.	up to 24 hours after inclusion
Secondary	Complementary medicines	Use and characterization of complementary medicines necessary for maternal well-being during caesarean section.	Between inclusion and cesarean section
Secondary	Postpartum hemorrhage	Postpartum hemorrhage (blood loss of more than 500 ml)	up to 24 hours after inclusion
Secondary	Paediatric wellness	Paediatric wellness criteria (umbilical cord pH less than 7.0 ; umbilical cord lactate)	at birth
Secondary	Anesthesia level	Anesthesia level one hour after surgical incision	one hour after surgical incision
Secondary	Maternal satisfaction	Maternal satisfaction regarding analgesia and anesthesia during caesarean section.	up to 4 hours after inclusion