Bicarbonate Epidural Injection in Emergency Caesarian (BiEpIC)
Primary Purpose
Emergency Caesarean
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
2% adrenaline lidocaine associated with 4.2% sodium bicarbonate
2% adrenaline lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Emergency Caesarean
Eligibility Criteria
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
Sites / Locations
- Chu Reims
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
alkalinization of adrenaline lidocaine solution arm
adrenaline lidocaine solution arm
Arm Description
conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an alkalinization of adrenaline lidocaine solution
conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using a adrenaline lidocaine solution
Outcomes
Primary Outcome Measures
delay in obtaining a T6 anesthetic level
delay to obtain a T6 anesthetic level evaluated in minute
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04255121
Brief Title
Bicarbonate Epidural Injection in Emergency Caesarian
Acronym
BiEpIC
Official Title
Interest of the Alkalinization of the Adrenaline Lidocaine Solution for Conversion of Epidural Analgesia Into Epidural Anesthesia During an Emergency Caesarean
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
December 13, 2020 (Actual)
Study Completion Date
February 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergency Caesarean
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
alkalinization of adrenaline lidocaine solution arm
Arm Type
Experimental
Arm Description
conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an alkalinization of adrenaline lidocaine solution
Arm Title
adrenaline lidocaine solution arm
Arm Type
Active Comparator
Arm Description
conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using a adrenaline lidocaine solution
Intervention Type
Drug
Intervention Name(s)
2% adrenaline lidocaine associated with 4.2% sodium bicarbonate
Intervention Description
conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an alkalinization of adrenaline lidocaine solution
Intervention Type
Drug
Intervention Name(s)
2% adrenaline lidocaine
Intervention Description
conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an adrenaline lidocaine solution
Primary Outcome Measure Information:
Title
delay in obtaining a T6 anesthetic level
Description
delay to obtain a T6 anesthetic level evaluated in minute
Time Frame
15 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Bicarbonate Epidural Injection in Emergency Caesarian
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