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OpenTrials
Completed

NCT Number: NCT04255121

Bicarbonate Epidural Injection in Emergency Caesarian

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Chu Reims

Reims, 51092, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2% adrenaline lidocaine associated with 4.2% sodium bicarbonate

Drug

conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an alkalinization of adrenaline lidocaine solution

2% adrenaline lidocaine

Drug

conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an adrenaline lidocaine solution

Primary outcomes

  1. delay in obtaining a T6 anesthetic level

    Time frame: 15 minutes

    delay to obtain a T6 anesthetic level evaluated in minute

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

Interest of the Alkalinization of the Adrenaline Lidocaine Solution for Conversion of Epidural Analgesia Into Epidural Anesthesia During an Emergency Caesarean

Acronym: BiEpIC

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.