EpiConCES - Epidural Lidocaine for Conversion to CaEsarean Section
- Conditions
- Pregnant Women>37SA
- Interventions
- Registration Number
- NCT02895022
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 40
- Pregnant > 37SA
- Between 150 and 190cm
- IMC between 20 and 40
- Single pregnancy
- Elective cesarean indication during obstetric labor
- Presentation of siege
- Extreme and semi emergency caesarean indication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lidocaine 2% adrénalinée 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. Lidocaine 2% adrénalinée Epidural catheter 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. Lidocaine 2% adrénalinée Caesarean section 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.
- Primary Outcome Measures
Name Time Method Success or failure of lidocaine 2% with epinephrine dose administered at day 1
- Secondary Outcome Measures
Name Time Method 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 Study tolerance of epidural anesthesia for caesarean section at day 1 Study tolerance - including hemodynamics - of epidural anesthesia for caesarean section depending on the dose of 2% lidocaine with epinephrine administered.
maternal pain (Visual Analog Scale) at day 1 maternal satisfaction at day 1 nausea and vomiting intraoperatively at day 1 fetal arterial and venous cord pH at day 1 Apgar score at day 1 Intravenous sedation for inadequate anesthesia at day 1
Trial Locations
- Locations (1)
Chu Clermont-Ferrand
🇫🇷Clermont-Ferrand, France