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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstetric Labor Complications
• Intervention / Treatment: Drug: Lidocaine epinephrine buffered with sodium bicarbonate; Drug: Lidocaine epinephrine

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 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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Bayonne, France
    • CH de la Côte Basque
  • Bordeaux, France
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; In this arm patients will receive for epidural extension a Lidocaine epinephrine buffered with sodium bicarbonate.	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.
Active Comparator: Comparator group; In this arm patients will receive for epidural extension only Lidocaine epinephrine.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resort to general anaesthesia	Resort to general anaesthesia for insufficient analgesia after epidural extension for extremely urgent caesarean section.	15 minutes after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Complementary medicines	Use and characterization of complementary medicines necessary for maternal well-being during caesarean section.	Between inclusion and cesarean section
Postpartum hemorrhage	Postpartum hemorrhage (blood loss of more than 500 ml)	up to 24 hours after inclusion
Paediatric wellness	Paediatric wellness criteria (umbilical cord pH less than 7.0 ; umbilical cord lactate)	at birth
Anesthesia level	Anesthesia level one hour after surgical incision	one hour after surgical incision
Maternal satisfaction	Maternal satisfaction regarding analgesia and anesthesia during caesarean section.	up to 4 hours after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Antoine BENARD, Dr, University Hospital, Bordeaux; Principal Investigator: Thomas LECHAT, Dr, University Hospital, Bordeaux; Study Director: Karine NOUETTE-GAULAIN, Pr, University Hospital, Bordeaux

Publications and helpful links

General Publications

• Lechat T, d'Aprigny T, Henriot J, Arthur J, Sylla D, Benard A, Nouette-Gaulain K. Quick Epidural Top-up with Alkalinized Lidocaine for emergent caesarean delivery (QETAL study): protocol for a randomized, controlled, bicentric trial. Trials. 2023 May 19;24(1):341. doi: 10.1186/s13063-023-07366-1.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Actual): July 8, 2024
• Study Completion (Actual): July 8, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: epidural analgesia; sodium bicarbonate; caesarean section; local anesthetics; obstetric labor; alkalinization; extremely urgent
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Obstetric Labor Complications; Inorganic Chemicals; Sodium Compounds; Carbon Compounds, Inorganic; Carbonates; Carbonic Acid; Bicarbonates; Sodium Bicarbonate
• Other Study ID Numbers: CHUBX 2021/36; 2021-006632-67 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No