Skip to content

Bicarbonate Epidural Injection in Emergency Caesarian

Interest of the Alkalinization of the Adrenaline Lidocaine Solution for Conversion of Epidural Analgesia Into Epidural Anesthesia During an Emergency Caesarean

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04255121
Acronym
BiEpIC
Enrollment
400
Registered
2020-02-05
Start date
2020-06-22
Completion date
2021-02-26
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergency Caesarean

Brief 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. 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.

Interventions

DRUG2% adrenaline lidocaine associated with 4.2% sodium bicarbonate

conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an alkalinization of adrenaline lidocaine solution

DRUG2% adrenaline lidocaine

conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an adrenaline lidocaine solution

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
delay in obtaining a T6 anesthetic level15 minutesdelay to obtain a T6 anesthetic level evaluated in minute

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026