Obstetric Labor ComplicationsPhase 2/3QETALNCT05313256
Quick Epidural Top-up With Alkalinized Lidocaine for Emergent Caesarean Delivery
A Phase 2/3 study testing Lidocaine epinephrine buffered with sodium bicarbonate and Lidocaine epinephrine in people with Obstetric Labor Complications, run by University Hospital, Bordeaux at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Labor Complications
- What is being tested?
- Lidocaine epinephrine buffered with sodium bicarbonate and Lidocaine epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Jul 2022to 8 Jul 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstetric Labor Complications
- Being tested
- Lidocaine epinephrine buffered with sodium bicarbonate, Lidocaine epinephrine
- Keywords
- epidural analgesia, caesarean section, sodium bicarbonate, local anesthetics, obstetric labor, alkalinization, extremely urgent
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine epinephrine buffered with sodium bicarbonateDrug
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 epinephrineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | In this arm patients will receive for epidural extension a Lidocaine epinephrine buffered with sodium bicarbonate. Receives: Drug: Lidocaine epinephrine buffered with sodium bicarbonate |
| Comparator group | Active comparator | In this arm patients will receive for epidural extension only Lidocaine epinephrine. Receives: Drug: Lidocaine epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resort to general anaesthesia
Resort to general anaesthesia for insufficient analgesia after epidural extension for extremely urgent caesarean section.
Measured: 15 minutes after inclusion
Secondary outcomes (8)
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
Measured: 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
Measured: 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.
Measured: up to 24 hours after inclusion
Complementary medicines
Use and characterization of complementary medicines necessary for maternal well-being during caesarean section.
Measured: Between inclusion and cesarean section
Postpartum hemorrhage
Postpartum hemorrhage (blood loss of more than 500 ml)
Measured: up to 24 hours after inclusion
Paediatric wellness
Paediatric wellness criteria (umbilical cord pH less than 7.0 ; umbilical cord lactate)
Measured: at birth
Anesthesia level
Anesthesia level one hour after surgical incision
Measured: one hour after surgical incision
Maternal satisfaction
Maternal satisfaction regarding analgesia and anesthesia during caesarean section.
Measured: up to 4 hours after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start14 Jul 2022
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstetric Labor ComplicationsStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas LECHAT, Dr, Principal investigator, University Hospital, BordeauxAntoine BENARD, Dr, Study chair, University Hospital, BordeauxKarine NOUETTE-GAULAIN, Pr, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313256
- Sponsor's protocol ID
- CHUBX 2021/36
- Other IDs
- 2021-006632-67
- Acronym
- QETAL
- Status last verified
- Nov 2024
- First submitted
- 28 Mar 2022
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37208675
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alkalinization of Adrenalized Lidocaine in Extending Epidural Analgesia for Extremely Urgent Cesarean Section During Labor: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05313256
- Acronym / sponsor ID
- QETAL / CHUBX 2021/36
- Conditions
- Obstetric Labor Complications
- Keywords
- epidural analgesia, caesarean section, sodium bicarbonate, local anesthetics, obstetric labor, alkalinization, extremely urgent
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Lidocaine epinephrine buffered with sodium bicarbonateIn this arm patients will receive for epidural extension a Lidocaine epinephrine buffered with sodium bicarbonate. |
| Comparator group | Active comparator | Drug: Lidocaine epinephrineIn this arm patients will receive for epidural extension only Lidocaine epinephrine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine epinephrine buffered with sodium bicarbonateWhen 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. | Drug | Experimental group |
| Lidocaine epinephrineWhen 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. | Drug | Comparator group |
Primary outcome
Resort to general anaesthesia
Time frame: 15 minutes after inclusion
Resort to general anaesthesia for insufficient analgesia after epidural extension for extremely urgent caesarean section.
8 secondary outcomes
Delay between fetal extraction decision and birth
Time frame: Between inclusion and birth
Delay between fetal extraction decision and incision
Time frame: Between inclusion and cesarean section
Maternal complications
Time frame: up to 24 hours after inclusion
Complementary medicines
Time frame: Between inclusion and cesarean section
Postpartum hemorrhage
Time frame: up to 24 hours after inclusion
Paediatric wellness
Time frame: at birth
Anesthesia level
Time frame: one hour after surgical incision
Maternal satisfaction
Time frame: up to 4 hours after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 37208675Lechat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas LECHAT, Dr principal investigator
University Hospital, Bordeaux
Antoine BENARD, Dr study chair
University Hospital, Bordeaux
Karine NOUETTE-GAULAIN, Pr study director
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lidocaine epinephrine buffered with sodium bicarbonate and Lidocaine epinephrine in people with Obstetric Labor Complications, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resort to general anaesthesia (time frame: 15 minutes after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05313256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.