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EpiConCES - Epidural Lidocaine for Conversion to CaEsarean Section

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02895022
Acronym
EpiConCES
Enrollment
40
Registered
2016-09-09
Start date
2016-09-05
Completion date
2018-12-31
Last updated
2018-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant Women>37SA

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.

Interventions

DRUGLidocaine 2% adrénalinée
PROCEDURECaesarean section

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Success or failure of lidocaine 2% with epinephrine dose administeredat day 1

Secondary

MeasureTime frameDescription
maternal pain (Visual Analog Scale)at day 1
maternal satisfactionat day 1
nausea and vomiting intraoperativelyat day 1
blood pressure (PAM, PAS (mmHg))at day 1
fluid replacement (ml)at day 1
Study tolerance of epidural anesthesia for caesarean sectionat day 1Study tolerance - including hemodynamics - of epidural anesthesia for caesarean section depending on the dose of 2% lidocaine with epinephrine administered.
necessary to use vasopressorsat day 1
Apgar scoreat day 1
fetal arterial and venous cord pHat day 1
Intravenous sedation for inadequate anesthesiaat day 1
hypotensionat day 1

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr04 73 75 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026