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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
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emergency Caesarean

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
February 3, 2020
Last Updated
February 26, 2021
Sponsor
CHU de Reims
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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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