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OpenTrials
Completed

NCT Number: NCT02573987

MEOPA Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.

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

Completed

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital St Joseph

Marseille, 13008, France

About this study

Compare anxiety discomfort and side effects

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen/nitrous oxide equimolar mix

Drug

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

Other names: MEOPA

Lidocaine

Drug

standard strategy by local injection anesthesia of lidocaine

Primary outcomes

  1. Analgesia efficiency

    Time frame: 5 min after procedure

    assessment of pain with visual analog scale

Secondary outcomes

  1. assessment of anxiety

    Time frame: 5 min after biopsy

    assessment of anxiety with visual analog scale

Sponsors and collaborators

Lead sponsor

Hospital St. Joseph, Marseille, France

Other

Registry information

Official study title

MEOPA (Equimolar Mix of Oxygen and Nitrogen Monoxide) Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.

Acronym: MELIBIO

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Oct 12, 2015
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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