MEOPA Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling. (MELIBIO)

Hospital Saint Joseph

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Oxygen/nitrous oxide equimolar mix; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02573987

A121414-31

Details and patient eligibility

About

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

Full description

Compare anxiety discomfort and side effects

Enrollment: 192 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

Oxygen/nitrous oxide equimolar mix

Active Comparator group

Description:

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

Treatment:

Drug: Oxygen/nitrous oxide equimolar mix

Lidocaine

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine