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EpiConCES - Epidural Lidocaine for Conversion to CaEsarean Section

U

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

Pregnant Women>37SA

Treatments

Procedure: Caesarean section
Device: Epidural catheter
Drug: Lidocaine 2% adrénalinée

Study type

Interventional

Funder types

Other

Identifiers

NCT02895022
2016-000224-26 (Other Identifier)
CHU-0271

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Lidocaine 2% adrénalinée
Experimental group
Description:
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.
Treatment:
Device: Epidural catheter
Procedure: Caesarean section
Drug: Lidocaine 2% adrénalinée

Trial contacts and locations

1

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Central trial contact

Patrick LACARIN

Data sourced from clinicaltrials.gov

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