MEOPA Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.

NCT ID: NCT02573987

Last Updated: 2018-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-13

Study Completion Date

2016-12-27

Brief Summary

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

Detailed Description

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Compare anxiety discomfort and side effects

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxygen/nitrous oxide equimolar mix

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

Group Type ACTIVE_COMPARATOR

Oxygen/nitrous oxide equimolar mix

Intervention Type DRUG

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

Lidocaine

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

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

standard strategy by local injection anesthesia of lidocaine

Interventions

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Oxygen/nitrous oxide equimolar mix

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

Intervention Type DRUG

Lidocaine

standard strategy by local injection anesthesia of lidocaine

Intervention Type DRUG

Other Intervention Names

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MEOPA

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnant under 18
* multiple pregnancies
* pregnancy inferior 11 aw
* no informed consent signature
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital St. Joseph, Marseille, France

OTHER

Sponsor Role lead

Responsible Party

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Raoul Desbriere

Dr Desbriere

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raoul Desbriere, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital st Joseph Marseille France

Locations

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Hôpital St Joseph

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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A121414-31

Identifier Type: -

Identifier Source: org_study_id

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