Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
400 participants
INTERVENTIONAL
2020-06-22
2021-02-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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alkalinization of adrenaline lidocaine solution arm
conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an alkalinization of adrenaline lidocaine solution
2% 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
adrenaline lidocaine solution arm
conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using a adrenaline lidocaine solution
2% adrenaline lidocaine
conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an adrenaline lidocaine solution
Interventions
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2% 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
2% adrenaline lidocaine
conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an adrenaline lidocaine solution
Eligibility Criteria
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Inclusion Criteria
* 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 for whom epidural analgesia cannot be used
* women for whom epidural analgesia is not effective
18 Years
FEMALE
No
Sponsors
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CHU de Reims
OTHER
Responsible Party
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Locations
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Chu Reims
Reims, , France
Countries
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Other Identifiers
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PO19144*
Identifier Type: -
Identifier Source: org_study_id
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