Emergency CaesareanPhase 3BiEpICNCT04255121
Bicarbonate Epidural Injection in Emergency Caesarian
A Phase 3 study testing 2% adrenaline lidocaine associated with 4.2% sodium bicarbonate and 2% adrenaline lidocaine in people with Emergency Caesarean, run by CHU de Reims at 1 site in France.
Trial summary
During labor, pain is systematic. In France, epidural analgesia is the gold standard to fight pain. Sometimes, emergency situations involve the maternal or fetal prognosis and require an emergency fetal extraction by caesarean. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Emergency Caesarean
- What is being tested?
- 2% adrenaline lidocaine associated with 4.2% sodium bicarbonate and 2% adrenaline lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2020to 26 Feb 2021
- Phase
- Phase 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
- pregnant women followed up in the Reims University Hospital
- women whose birth is expected by vaginal delivery in the Reims University Hospital
- women wishing to benefit from epidural analgesia
- women agreeing to participate in the research and having signed informed consent
- women aged 18 years old and more
- women affiliated to a social security system
Who cannot join
- women who don't benefit from emergency caesarian (vaginal delivery or scheduled caesarian)
- women for whom epidural analgesia cannot be used
- women for whom epidural analgesia is not effective
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of the Alkalinization of the Adrenaline Lidocaine Solution for Conversion of Epidural Analgesia Into Epidural Anesthesia During an Emergency Caesarean
During labor, pain is systematic. In France, epidural analgesia is the gold standard to fight pain.
Sometimes, emergency situations involve the maternal or fetal prognosis and require an emergency fetal extraction by caesarean. When an effective epidural analgesia is in place, an injection of adrenaline lidocaine converts this epidural analgesia into an epidural anesthesia allowing a surgical procedure. Sometimes, the time required to set up the anesthesia cannot be expected and a general anesthesia is performed.
Read more
Local anesthetics used during epidural analgesia have Pka between 7.8 and 8.1. In solution, local anesthetics exist in two forms: an un-ionized form and an ionized form. The non-ionized form is liposoluble and crosses the lipid membranes to reach the site of intracellular action. The non-ionized form conditions the time taken to install anesthesia.
When the pH of the solution is equal to Pka, un-ionized and ionized form are present in equal quantity. Commercial local anesthetic solutions have acidic pH and so contained a majority of ionized form. Alkalinization of local anesthetics solution should bring the pH closer to pKa and therefore to favor a greater proportion of non-ionized form.
Read the detailed description
The aim of this study is to evaluate impact of an alkalinization of adrenaline lidocaine solution for conversion of epidural analgesia into epidural anesthesia during an emergency caesarean.
- Conditions
- Emergency Caesarean
- Being tested
- 2% adrenaline lidocaine associated with 4.2% sodium bicarbonate, 2% adrenaline lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% adrenaline lidocaine associated with 4.2% sodium bicarbonateDrug
conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an alkalinization of adrenaline lidocaine solution
2% adrenaline lidocaineDrug
conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an adrenaline lidocaine solution
| Study group | Role | What they receive |
|---|---|---|
| alkalinization of adrenaline lidocaine solution arm | Experimental | conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an alkalinization of adrenaline lidocaine solution Receives: Drug: 2% adrenaline lidocaine associated with 4.2% sodium bicarbonate |
| adrenaline lidocaine solution arm | Active comparator | conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using a adrenaline lidocaine solution Receives: Drug: 2% adrenaline lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
delay in obtaining a T6 anesthetic level
delay to obtain a T6 anesthetic level evaluated in minute
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start22 Jun 2020
- Primary completion13 Dec 2020
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency CaesareanStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255121
- Sponsor's protocol ID
- PO19144*
- Acronym
- BiEpIC
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Alkalinization of the Adrenaline Lidocaine Solution for Conversion of Epidural Analgesia Into Epidural Anesthesia During an Emergency Caesarean
- ClinicalTrials.gov ID
- NCT04255121
- Acronym / sponsor ID
- BiEpIC / PO19144*
- Conditions
- Emergency Caesarean
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 13 Dec 2020 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 5 Feb 2020 (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.
During labor, pain is systematic. In France, epidural analgesia is the gold standard to fight pain.
Sometimes, emergency situations involve the maternal or fetal prognosis and require an emergency fetal extraction by caesarean. When an effective epidural analgesia is in place, an injection of adrenaline lidocaine converts this epidural analgesia into an epidural anesthesia allowing a surgical procedure. Sometimes, the time required to set up the anesthesia cannot be expected and a general anesthesia is performed.
Local anesthetics used during epidural analgesia have Pka between 7.8 and 8.1. In solution, local anesthetics exist in two forms: an un-ionized form and an ionized form. The non-ionized form is liposoluble and crosses the lipid membranes to reach the site of intracellular action. The non-ionized form conditions the time taken to install anesthesia.
When the pH of the solution is equal to Pka, un-ionized and ionized form are present in equal quantity. Commercial local anesthetic solutions have acidic pH and so contained a majority of ionized form. Alkalinization of local anesthetics solution should bring the pH closer to pKa and therefore to favor a greater proportion of non-ionized form.
Detailed description
The aim of this study is to evaluate impact of an alkalinization of adrenaline lidocaine solution for conversion of epidural analgesia into epidural anesthesia during an emergency caesarean.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alkalinization of adrenaline lidocaine solution arm | Experimental | Drug: 2% adrenaline lidocaine associated with 4.2% sodium bicarbonateconversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an alkalinization of adrenaline lidocaine solution |
| adrenaline lidocaine solution arm | Active comparator | Drug: 2% adrenaline lidocaineconversion of epidural analgesia into epidural anesthesia during an emergency caesarean using a adrenaline lidocaine solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- pregnant women followed up in the Reims University Hospital
- women whose birth is expected by vaginal delivery in the Reims University Hospital
- women wishing to benefit from epidural analgesia
- women agreeing to participate in the research and having signed informed consent
- women aged 18 years old and more
Key exclusion criteria (3 listed)
- women who don't benefit from emergency caesarian (vaginal delivery or scheduled caesarian)
- women for whom epidural analgesia cannot be used
- women for whom epidural analgesia is not effective
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 |
|---|---|---|
| 2% adrenaline lidocaine associated with 4.2% sodium bicarbonateconversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an alkalinization of adrenaline lidocaine solution | Drug | alkalinization of adrenaline lidocaine solution arm |
| 2% adrenaline lidocaineconversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an adrenaline lidocaine solution | Drug | adrenaline lidocaine solution arm |
Primary outcome
delay in obtaining a T6 anesthetic level
Time frame: 15 minutes
delay to obtain a T6 anesthetic level evaluated in minute
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 1 Mar 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Emergency Caesarean
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2% adrenaline lidocaine associated with 4.2% sodium bicarbonate and 2% adrenaline lidocaine in people with Emergency Caesarean, run by CHU de Reims at 1 site 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 6 inclusion and 3 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 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
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?
delay in obtaining a T6 anesthetic level (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2021.