Bicarbonate Epidural Injection in Emergency Caesarian

Phase 3

Completed

• Conditions: Emergency Caesarean
• Interventions: Drug: 2% adrenaline lidocaine associated with 4.2% sodium bicarbonate; Drug: 2% adrenaline lidocaine

• Registration Number: NCT04255121
• Lead Sponsor: CHU de Reims

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.

Study Timeline

• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Study Start: 2020-06-22
• Primary Completion: 2020-12-13
• Status Verified: 2021-02
• Study Completion: 2021-02-26
• Last Update Submitted: 2021-02-26
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alkalinization of adrenaline lidocaine solution arm	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	2% adrenaline lidocaine	conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using a adrenaline lidocaine solution

Primary Outcome Measures

Name	Time	Method
delay in obtaining a T6 anesthetic level	15 minutes	delay to obtain a T6 anesthetic level evaluated in minute

Trial Locations

Locations (1)

Chu Reims; 🇫🇷 Reims, France