NCT02264834

Brief Summary

Assess the impact of instrumentation and caesarean related to dyskinesia by reducing the concentration of local anesthetic and therefore the motor block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2018

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

3.7 years

First QC Date

August 1, 2014

Last Update Submit

May 30, 2018

Conditions

First Pregnancy

Keywords

epiduralprimiparous patientdeambulation

Outcome Measures

Primary Outcomes (4)

  • Time between peridural application and childbirth

    This will be used to assess labor.

    at delivery

  • Caesarian

    This will be used to assess labor. Was a caesarian necessary (yes-no) ?

    at delivery

  • Instrumentalisation

    This will be used to assess labor. Was an instrumentalisation (defined as the use of forceps or suction cups) necessary at delivery (yes-no) ?

    at delivery

  • Apgar score of the baby

    Evaluation of the baby, using the Apgar score. This will be used to assess labor.

    at delivery

Secondary Outcomes (3)

  • Bromage score

    1h after the start of the peridural

  • Romberg test

    1h after the start of the peridural

  • Arterial tension

    1h after the start of the peridural

Study Arms (2)

Control group

ACTIVE COMPARATOR

Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.1% + Sufentanil 0.2 µg/mL

Drug: Levobupivacaine 0.1% + Sufentanil 0.2µg/mlProcedure: Lumbar epidural analgesia

Ambulatory group

EXPERIMENTAL

Lumbar epidural analgesia during the labour and end up after delivery Levobupivacaine 0.07% + Sufentanil 0.3 µg/mL

Drug: Levobupivacaine 0.07% + Sufentanil 0.3µg/mlProcedure: Lumbar epidural analgesia

Interventions

Levobupivacaine 0.1% + Sufentanil 0.2µg/mlDRUG

Levobupivacaine 0.1% + Sufentanil 0.2µg/ml

Also known as: control group
Control group
Levobupivacaine 0.07% + Sufentanil 0.3µg/mlDRUG

Levobupivacaine 0.07% + Sufentanil 0.3µg/ml

Also known as: ambulatory group
Ambulatory group
Lumbar epidural analgesiaPROCEDURE

Introduction of a catheter in lumbar epidural space

Also known as: labor analgesia
Ambulatory groupControl group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Free written consent.
  • ASA I or II,
  • Primipara, unique and pregnancy over 36 weeks fetus in cephalic, cervical dilation between 3-6 cm
  • VAS\> 30 mm
  • No contraindications to peridural

You may not qualify if:

  • Twin pregnancy, less than 36 weeks and 42 weeks
  • Fetus in breech position
  • Analgesia and sedation within 6h
  • Contraindications to peridural

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUB

Brussels, 1020, Belgium

Location

MeSH Terms

Interventions

LevobupivacaineSufentanilControl Groups

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Philippe Vanderlinden

    CHUB

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
primary investigator

Study Record Dates

First Submitted

August 1, 2014

First Posted

October 15, 2014

Study Start

July 1, 2014

Primary Completion

March 20, 2018

Study Completion

March 20, 2018

Last Updated

May 31, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)