NCT02573987

Brief Summary

determine if efficiency of MEOPA anesthesia is at least equivalent to local anesthetics into the chorionic villus sampling in the first trimester of pregnancy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_4 pain

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

March 13, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2016

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

2.1 years

First QC Date

September 17, 2015

Last Update Submit

January 4, 2018

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Analgesia efficiency

    assessment of pain with visual analog scale

    5 min after procedure

Secondary Outcomes (1)

  • assessment of anxiety

    5 min after biopsy

Study Arms (2)

Oxygen/nitrous oxide equimolar mix

ACTIVE COMPARATOR

96 participants undergoing chorionic villi sampling. self administered inhalation of equimolar mixture of oxygen and nitrous oxide (MEOPA)

Drug: Oxygen/nitrous oxide equimolar mix

Lidocaine

ACTIVE COMPARATOR

96 participants undergoing chorionic villi sampling infiltrative local anaesthesia of 1% lidocaine

Drug: Lidocaine

Interventions

Oxygen/nitrous oxide equimolar mixDRUG

an experimental strategy inhalation by means of a breathing mask diffusing MEOPA

Also known as: MEOPA
Oxygen/nitrous oxide equimolar mix
LidocaineDRUG

standard strategy by local injection anesthesia of lidocaine

Lidocaine

Eligibility Criteria

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

You may qualify if:

  • pregnant
  • and over
  • monofetal pregnancy
  • chorionic villus sampling medical indication without contra indication
  • informed consent signature

You may not qualify if:

  • pregnant under 18
  • multiple pregnancies
  • pregnancy inferior 11 aw
  • no informed consent signature

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital St Joseph

Marseille, 13008, France

Location

MeSH Terms

Conditions

Pain

Interventions

OxygenMeopaLidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGasesAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Raoul Desbriere, MD

    Hôpital st Joseph Marseille France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Desbriere

Study Record Dates

First Submitted

September 17, 2015

First Posted

October 12, 2015

Study Start

March 13, 2013

Primary Completion

April 1, 2015

Study Completion

December 27, 2016

Last Updated

January 5, 2018

Record last verified: 2018-01

Locations

FR(1)