NCT05313256

Brief Summary

Prospective randomized study comparing the use of lidocaine 2% with epinephrine buffered with sodium bicarbonate and lidocaine 2% with epinephrine as epidural top-up for extremely urgent cesarean section during labour.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

2 active sites

Status
completed

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

March 28, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 14, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2024

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

2 years

First QC Date

March 28, 2022

Last Update Submit

November 13, 2024

Conditions

Obstetric Labor Complications

Keywords

epidural analgesiacaesarean sectionsodium bicarbonatelocal anestheticsobstetric laboralkalinizationextremely urgent

Outcome Measures

Primary Outcomes (1)

  • Resort to general anaesthesia

    Resort to general anaesthesia for insufficient analgesia after epidural extension for extremely urgent caesarean section.

    15 minutes after inclusion

Secondary Outcomes (8)

  • Delay between fetal extraction decision and birth

    Between inclusion and birth

  • Delay between fetal extraction decision and incision

    Between inclusion and cesarean section

  • Maternal complications

    up to 24 hours after inclusion

  • Complementary medicines

    Between inclusion and cesarean section

  • Postpartum hemorrhage

    up to 24 hours after inclusion

  • +3 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

In this arm patients will receive for epidural extension a Lidocaine epinephrine buffered with sodium bicarbonate.

Drug: Lidocaine epinephrine buffered with sodium bicarbonate

Comparator group

ACTIVE COMPARATOR

In this arm patients will receive for epidural extension only Lidocaine epinephrine.

Drug: Lidocaine epinephrine

Interventions

Lidocaine epinephrine buffered with sodium bicarbonateDRUG

When an extremely urgent fetal extraction by caesarean section is decided, the patient will be randomized. An epidural top-up will then be performed with Lidocaine epinephrine buffered with sodium bicarbonate.

Experimental group
Lidocaine epinephrineDRUG

When an extremely urgent fetal extraction by caesarean section is decided, the patient will be randomized. An epidural top-up will then be performed with Lidocaine epinephrine.

Comparator group

Eligibility Criteria

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

You may qualify if:

  • Adult patients, affiliated to social security
  • Informed consent signed by the participant and the investigating physician at the latest after the therapeutic intervention
  • Initial indication for vaginal delivery
  • Benefiting from emergency caesarean section during labour for fetal extraction with a maximum 15-minute decision-to-delivery delay (i.e. extremely urgent caesarean section)

You may not qualify if:

  • Opposition to participation in research before delivery
  • Refusal or impossibility of informed consent
  • Lack of understanding or significant language barrier
  • Initial indication for general anaesthesia defined by the following situations: non-functional epidural analgesia, altered consciousness, eclampsia, suspicion of amniotic embolism, confirmed or suspected severe haemorrhage occurring before birth
  • Contraindication to the use of the products defined in the protocol : adrenalized lidocaine ; sodium bicarbonate.
  • Persons placed under judicial protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CH de la Côte Basque

Bayonne, France

Location

CHU de Bordeaux

Bordeaux, France

Location

Related Publications (1)

  • Lechat T, d'Aprigny T, Henriot J, Arthur J, Sylla D, Benard A, Nouette-Gaulain K. Quick Epidural Top-up with Alkalinized Lidocaine for emergent caesarean delivery (QETAL study): protocol for a randomized, controlled, bicentric trial. Trials. 2023 May 19;24(1):341. doi: 10.1186/s13063-023-07366-1.

    PMID: 37208675DERIVED

MeSH Terms

Conditions

Obstetric Labor Complications

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Officials

  • Thomas LECHAT, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Antoine BENARD, Dr

    University Hospital, Bordeaux

    STUDY CHAIR

  • Karine NOUETTE-GAULAIN, Pr

    University Hospital, Bordeaux

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 6, 2022

Study Start

July 14, 2022

Primary Completion

July 8, 2024

Study Completion

July 8, 2024

Last Updated

November 15, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)