Bicarbonate Epidural Injection in Emergency Caesarian (BiEpIC)

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.

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.

Study Overview

• Status: Completed
• Conditions: Emergency Caesarean
• Intervention / Treatment: Drug: 2% adrenaline lidocaine associated with 4.2% sodium bicarbonate; Drug: 2% adrenaline lidocaine

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Reims, France, 51092
    • CHU Reims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: alkalinization of adrenaline lidocaine solution arm; conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an alkalinization of adrenaline lidocaine solution	Drug: 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
Active Comparator: adrenaline lidocaine solution arm; conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using a adrenaline lidocaine solution	Drug: 2% adrenaline lidocaine; conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an adrenaline lidocaine solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
delay in obtaining a T6 anesthetic level	delay to obtain a T6 anesthetic level evaluated in minute	15 minutes

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2020
• Primary Completion (Actual): December 13, 2020
• Study Completion (Actual): February 26, 2021

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: PO19144*

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No