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.
Trial summary
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. Read more about this study
- 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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
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.
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.
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
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?
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.
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?
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; AzTrials last refreshed its copy on 8 Nov 2026.