EpiConCES - Epidural Lidocaine for Conversion to CaEsarean Section

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pregnant Women>37SA

Intervention / Treatment
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* Drug: Lidocaine 2% adrénalinée
* Device: Epidural catheter
* Procedure: Caesarean section


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine 2% adrénalinée<br>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<br> <br> Device: Epidural catheter<br> <br> Procedure: Caesarean section<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |