PainPhase 4MELIBIONCT02573987
MEOPA Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.
A Phase 4 study testing Oxygen/nitrous oxide equimolar mix and Lidocaine in people with Pain, run by Hospital St. Joseph, Marseille, France at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- Oxygen/nitrous oxide equimolar mix and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteFrance
- Study dates
- 13 Mar 2013to 27 Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant
- 18 and over
- monofetal pregnancy
- chorionic villus sampling medical indication without contra indication
- informed consent signature
Who cannot join
- pregnant under 18
- multiple pregnancies
- pregnancy inferior 11 aw
- no informed consent signature
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MEOPA (Equimolar Mix of Oxygen and Nitrogen Monoxide) 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
Read the detailed description
Compare anxiety discomfort and side effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen/nitrous oxide equimolar mixDrug
Also called MEOPA
an experimental strategy inhalation by means of a breathing mask diffusing MEOPA
LidocaineDrug
standard strategy by local injection anesthesia of lidocaine
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Oxygen/nitrous oxide equimolar mix |
| Lidocaine | Active comparator | 96 participants undergoing chorionic villi sampling infiltrative local anaesthesia of 1% lidocaine Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia efficiency
assessment of pain with visual analog scale
Measured: 5 min after procedure
Secondary outcomes (1)
assessment of anxiety
assessment of anxiety with visual analog scale
Measured: 5 min after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study start13 Mar 2013
- Primary completionApr 2015
- Study completion27 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raoul Desbriere, Hospital St. Joseph, Marseille, France
- Investigators
- Raoul Desbriere, MD, Principal investigator, Hôpital st Joseph Marseille France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573987
- Sponsor's protocol ID
- A121414-31
- Acronym
- MELIBIO
- Status last verified
- Jan 2018
- First submitted
- 17 Sep 2015
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEOPA (Equimolar Mix of Oxygen and Nitrogen Monoxide) Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.
- ClinicalTrials.gov ID
- NCT02573987
- Acronym / sponsor ID
- MELIBIO / A121414-31
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 13 Mar 2013 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- 27 Dec 2016 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen/nitrous oxide equimolar mix | Active comparator | Drug: Oxygen/nitrous oxide equimolar mix96 participants undergoing chorionic villi sampling. self administered inhalation of equimolar mixture of oxygen and nitrous oxide (MEOPA) |
| Lidocaine | Active comparator | Drug: Lidocaine96 participants undergoing chorionic villi sampling infiltrative local anaesthesia of 1% lidocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pregnant
- 18 and over
- monofetal pregnancy
- chorionic villus sampling medical indication without contra indication
- informed consent signature
Key exclusion criteria (4 listed)
- pregnant under 18
- multiple pregnancies
- pregnancy inferior 11 aw
- no informed consent signature
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen/nitrous oxide equimolar mixAlso: MEOPAan experimental strategy inhalation by means of a breathing mask diffusing MEOPA | Drug | Oxygen/nitrous oxide equimolar mix |
| Lidocainestandard strategy by local injection anesthesia of lidocaine | Drug | Lidocaine |
Primary outcome
Analgesia efficiency
Time frame: 5 min after procedure
assessment of pain with visual analog scale
1 secondary outcome
assessment of anxiety
Time frame: 5 min after biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raoul Desbriere, MD principal investigator
Hôpital st Joseph Marseille France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxygen/nitrous oxide equimolar mix and Lidocaine in people with Pain, run by Hospital St. Joseph, Marseille, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia efficiency (time frame: 5 min after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.