Pregnant WomenPhase 3MASEANCT02868944

Interest of the Injection of Morphine, in Addition to a Local Anesthetic When Performing a Combined Spinal-epidural for Labor Analgesia

A Phase 3 study testing experimental group : sequential combined spinal epidural with local anesthetic injection (chirocaine) associated with morphine (sufentanil). in people with Pregnant Women, run by CHU de Reims at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 years, women only
Conditions the study is for: Pregnant Women
What is being tested?: experimental group : sequential combined spinal epidural with local anesthetic injection (chirocaine) associated with morphine (sufentanil).
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 1 siteFrance
Study dates: Aug 2014to 18 Jan 2017
Phase: Phase 3
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 to 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

pregnant patients
patients who experienced a physiological course of pregnancy
patients for which it was estimated eutrophic fetus without pathology found during ultrasound
patient consenting to participate to the study
patient enrolled in the national healthcare insurance program
patient older than 18 years and younger than 40 years

Who cannot join

twin pregnancy
contraindication to sequential combined spinal epidural

Trial locations and contacts

1 site in 1 country.

France1 site

Chu de Reims
Reims, 51092

Other trials in France

About this study

The addition of morphine to a local anesthetic when performing an epidural analgesia during labor analgesia has improved the efficiency and the action duration of analgesia. One limitation of this technique is the time of installation of the analgesic effect (about 30 minutes) when using the only epidural. Therefore, the technique of sequential combined spinal epidural was introduced. This is to shorten the installation time by direct injection into the cerebrospinal fluid. This allows a good efficiency in less than 10 minutes. It has been shown that low doses of sufentanil (strong opioid) in spinal anesthesia could potentiate the effect of the local anesthetic.

Read the detailed description

Compare the results of obstetric analgesia by sequential combined spinal epidural with local anesthetic injection associated with morphine and a sequential obstetric analgesia by sequential combined spinal epidural with local anesthetic injection alone

Conditions: Pregnant Women
Being tested: experimental group : sequential combined spinal epidural with local anesthetic injection (chirocaine) associated with morphine (sufentanil)., control group : sequential combined spinal epidural with local anesthetic injection (chirocaine) alone.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

experimental group : sequential combined spinal epidural with local anesthetic injection (chirocaine) associated with morphine (sufentanil).Drug
control group : sequential combined spinal epidural with local anesthetic injection (chirocaine) alone.Drug

Study groups in NCT02868944
Study group	Role	What they receive
experimental group	Experimental	sequential combined spinal epidural with local anesthetic injection associated with morphine Receives: Drug: experimental group : sequential combined spinal epidural with local anesthetic injection (chirocaine) associated with morphine (sufentanil).
control group	Active comparator	sequential combined spinal epidural with local anesthetic injection alone Receives: Drug: control group : sequential combined spinal epidural with local anesthetic injection (chirocaine) alone.

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual analog pain scale
Pain evaluated inferior at 3 on 10 using a visual analog pain scale
Measured: after 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201418 Jan 2017

First posted16 Aug 2016 (estimated)
Study startAug 2014
Primary completion18 Jan 2017
Study completion18 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pregnant WomenStudies of the same condition, open and under way.
More trials run by CHU de ReimsThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02868944
Sponsor's protocol ID: PA14018
Acronym: MASEA
Status last verified: Jan 2018
First submitted: 8 Aug 2016
Last updated: 9 Jan 2018
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interest of the Injection of Morphine, in Addition to a Local Anesthetic When Performing a Combined Spinal-epidural for Labor Analgesia
ClinicalTrials.gov ID: NCT02868944
Acronym / sponsor ID: MASEA / PA14018
Conditions: Pregnant Women
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: CHU de ReimsUniversity, hospital or other
Study start: Aug 2014
Primary completion: 18 Jan 2017 (actual)
Study completion: 18 Jan 2017 (actual)
First posted: 16 Aug 2016 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
experimental group	Experimental	Drug: experimental group : sequential combined spinal epidural with local anesthetic injection (chirocaine) associated with morphine (sufentanil).sequential combined spinal epidural with local anesthetic injection associated with morphine
control group	Active comparator	Drug: control group : sequential combined spinal epidural with local anesthetic injection (chirocaine) alone.sequential combined spinal epidural with local anesthetic injection alone

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

pregnant patients
patients who experienced a physiological course of pregnancy
patients for which it was estimated eutrophic fetus without pathology found during ultrasound
patient consenting to participate to the study
patient enrolled in the national healthcare insurance program

Key exclusion criteria (2 listed)

twin pregnancy
contraindication to sequential combined spinal epidural

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
experimental group : sequential combined spinal epidural with local anesthetic injection (chirocaine) associated with morphine (sufentanil).	Drug	experimental group
control group : sequential combined spinal epidural with local anesthetic injection (chirocaine) alone.	Drug	control group

Primary outcome

Visual analog pain scale
Time frame: after 5 minutes
Pain evaluated inferior at 3 on 10 using a visual analog pain scale

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 9 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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 2 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 9 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Visual analog pain scale (time frame: after 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02868944.

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 9 Jan 2018.