MEOPA Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Oxygen/nitrous oxide equimolar mix; Drug: Lidocaine

• Registration Number: NCT02573987
• Lead Sponsor: Hospital St. Joseph, Marseille, France

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

Detailed Description

Compare anxiety discomfort and side effects

Study Timeline

• Study Start: 2013-03-13
• Primary Completion: 2015-04
• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-12
• Study Completion: 2016-12-27
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxygen/nitrous oxide equimolar mix	Oxygen/nitrous oxide equimolar mix	96 participants undergoing chorionic villi sampling. self administered inhalation of equimolar mixture of oxygen and nitrous oxide (MEOPA)
Lidocaine	Lidocaine	96 participants undergoing chorionic villi sampling infiltrative local anaesthesia of 1% lidocaine

Primary Outcome Measures

Name	Time	Method
Analgesia efficiency	5 min after procedure	assessment of pain with visual analog scale

Secondary Outcome Measures

Name	Time	Method
assessment of anxiety	5 min after biopsy	assessment of anxiety with visual analog scale

Trial Locations

Locations (1)

Hôpital St Joseph; 🇫🇷 Marseille, France