NCT02895022

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

2.3 years

First QC Date

July 4, 2016

Last Update Submit

February 27, 2018

Conditions

Pregnant Women>37SA

Outcome Measures

Primary Outcomes (1)

  • Success or failure of lidocaine 2% with epinephrine dose administered

    at day 1

Secondary Outcomes (11)

  • Study tolerance of epidural anesthesia for caesarean section

    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

  • +6 more secondary outcomes

Study Arms (1)

Lidocaine 2% adrénalinée

EXPERIMENTAL

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% adrénalinéeDevice: Epidural catheterProcedure: Caesarean section

Interventions

Lidocaine 2% adrénalinéeDRUG
Lidocaine 2% adrénalinée
Epidural catheterDEVICE
Lidocaine 2% adrénalinée
Caesarean sectionPROCEDURE
Lidocaine 2% adrénalinée

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant \> 37SA
  • Between 150 and 190cm
  • IMC between 20 and 40
  • Single pregnancy
  • Elective cesarean indication during obstetric labor

You may not qualify if:

  • Presentation of siege
  • Extreme and semi emergency caesarean indication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Interventions

LidocaineCesarean Section

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDelivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Martine BONNIN

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2016

First Posted

September 9, 2016

Study Start

September 5, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations

FR(1)