EpiConCES - Epidural Lidocaine for Conversion to CaEsarean Section

Pregnant Women>37SA Clinical Trial

— EpiConCES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02895022
• Other study ID #: CHU-0271
• Secondary ID: 2016-000224-26
• Status: Recruiting
• Phase: N/A
• First received: July 4, 2016
• Last updated: February 27, 2018
• Start date: September 5, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnant Women>37SA

Intervention

Drug:
• Lidocaine 2% adrénalinée

Device:
• Epidural catheter

Procedure:
• Caesarean section

Locations

Country	Name	City	State
France	Chu Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success or failure of lidocaine 2% with epinephrine dose administered		at day 1
Secondary	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
Secondary	maternal pain (Visual Analog Scale)		at day 1
Secondary	maternal satisfaction		at day 1
Secondary	nausea and vomiting intraoperatively		at day 1
Secondary	blood pressure (PAM, PAS (mmHg))		at day 1
Secondary	fluid replacement (ml)		at day 1
Secondary	hypotension		at day 1
Secondary	necessary to use vasopressors		at day 1
Secondary	Apgar score		at day 1
Secondary	fetal arterial and venous cord pH		at day 1
Secondary	Intravenous sedation for inadequate anesthesia		at day 1