EpiConCES - Epidural Lidocaine for Conversion to CaEsarean Section (EpiConCES)

Determination of ED95 of 2% Lidocaine With Epinephrine for Converting Analgesia Epidural Anesthesia in Surgical Epidural in the Labor Current Cesarean

The need to resort to a midwifery course work in cesarean is a common practice. Epidural analgesia for labor analgesia is practiced in 90% of women in obstetric work, as when the cesarean decision is taken course work in practice and the recommendations are to use the epidural catheter in place to convert the epidural analgesia in epidural anesthesia by re-injecting a local anesthetic on the catheter. General anesthesia is reserved only cases of extreme urgency and cons-indications for regional anesthesia as a purveyor of high maternal morbidity and mortality.

The initial assumption is that the 2% lidocaine with epinephrine is the optimal and recommended local anesthetic solution.

Study Overview

• Status: Unknown
• Conditions: Pregnant Women>37SA
• Intervention / Treatment: Drug: Lidocaine 2% adrénalinée; Device: Epidural catheter; Procedure: Caesarean section

Detailed Description

There is a real variability in the volume administered by practitioners repository fault.

The main objective is to determine the ED95 dose of 2% lidocaine with epinephrine injected into the epidural catheter for which it does not arise from failure to surgical anesthesia for cesarean during labor.

The secondary objectives are to determine the failure risk factors, the hemodynamic consequences related to the volume administered and evaluate maternal satisfaction.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • Chu Clermont-Ferrand
    • Principal Investigator: Martine BONNIN
    • Sub-Investigator: Brigitte STORME
    • Sub-Investigator: Aurélie FOURNET-FAYARD
    • Sub-Investigator: Agnès BARRIERE
    • Sub-Investigator: Christian CHARTIER
    • Sub-Investigator: Giuseppe ROSANO
    • Sub-Investigator: Anne-Laure LAFAYE
    • Sub-Investigator: Lise VERNIS
    • Sub-Investigator: Julie FAYON
    • Sub-Investigator: Denis Gallot

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 > 37SA
• Between 150 and 190cm
• IMC between 20 and 40
• Single pregnancy
• Elective cesarean indication during obstetric labor

Exclusion Criteria:

• Presentation of siege
• Extreme and semi emergency caesarean indication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine 2% adrénalinée; The main objective is to determine the ED95 dose of 2% lidocaine with epinephrine injected into the epidural catheter for which it does not arise from failure to surgical anesthesia for cesarean during labor.	Drug: Lidocaine 2% adrénalinée; Device: Epidural catheter; Procedure: Caesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Success or failure of lidocaine 2% with epinephrine dose administered	at day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study tolerance of epidural anesthesia for caesarean section	Study tolerance - including hemodynamics - of epidural anesthesia for caesarean section depending on the dose of 2% lidocaine with epinephrine administered.	at day 1
maternal pain (Visual Analog Scale)		at day 1
maternal satisfaction		at day 1
nausea and vomiting intraoperatively		at day 1
blood pressure (PAM, PAS (mmHg))		at day 1
fluid replacement (ml)		at day 1
hypotension		at day 1
necessary to use vasopressors		at day 1
Apgar score		at day 1
fetal arterial and venous cord pH		at day 1
Intravenous sedation for inadequate anesthesia		at day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Martine BONNIN, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2016
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: July 4, 2016
• First Submitted That Met QC Criteria: September 5, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: CHU-0271; 2016-000224-26 (Other Identifier: 2016-000224-26)