Scheduled Caesarian SectionPhase 3NCT02184559
Postoperative Analgesia After Caesarean Section Under ALR: TAP Block Versus Catheter Scar Infiltration
A Phase 3 study testing Ropivacaine and The infiltration continues catheter in people with Scheduled Caesarian Section, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The purpose of the multimodal postoperative analgesia is to improve the quality of analgesia and reduce side effects of morphine (nausea, vomiting, sedation, urinary retention, respiratory depression ...). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Scheduled Caesarian Section
- What is being tested?
- Ropivacaine and The infiltration continues catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Feb 2015
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman whose age is 18 years
- Encircled Woman requiring a scheduled(programmed) caesarian, under spinal anesthesia or died combined(organized) spinal anesthesia
- Woman ASA I and II
- Term = 37 LIMITED COMPANIES
- Woman primipare or not
- Woman having signed an informed consent writes and making a commitment to respect the instructions of the protocol
Who cannot join
- Minor Woman
- Woman presenting a contraindication to the anesthesia périmédullaire: constitutional or acquired disorders(confusions) of the haemostasis, the allergy in the local anesthetics, the infectious context (hypertherm > 38.5 ° C)
- Woman presenting an intolerance or an allergy known about the morphine in the paracetamol or in AIN
- The surgical histories of laparotomy
- The morbid obesity BMI > 35
- Dysgravidies
Show all 9Show fewer
- Woman not being affiliated to the national insurance scheme
- Woman under legal protection
- Woman not having signed an informed consent
Trial locations and contacts
1 site in 1 country.
aurelie BOURGOIN contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
aurelie BOURGOIN, aurelie.bourgoin@ap-hm.fr
aurelie BOURGOIN
About this study
The purpose of the multimodal postoperative analgesia is to improve the quality of analgesia and reduce side effects of morphine (nausea, vomiting, sedation, urinary retention, respiratory depression ...). In the case of caesarean sections, the quality of analgesia allows one hand to improve the mother-child relationship and the quality of breastfeeding, the other to reduce the risk of postpartum depression and chronic pain . Two methods of administration of local anesthetics have been proven effective for analgesia of the abdominal wall under umbilical: The Transversus Abdominal Block Plan (TAP Block) and infiltration of the scar continues operating. The TAP block was performed under ultrasound guidance by the anesthesiologist after the intervention in a single injection of local anesthetic in the abdominal wall and has a period of limited and variable. The infiltration continues catheter is placed by the surgeon before closing the wound and allows the infusion of local anesthetics for 48 hours.
The purpose of this study was to compare morphine consumption between both techniques, and the quality of analgesia and side effects of morphine
- Conditions
- Scheduled Caesarian Section
- Being tested
- Ropivacaine, The infiltration continues catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
comparaison of two methods of administration for analgesia using the same drugs in the same indication after Caesarean section
The infiltration continues catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Experimental | Not described Receives: Drug: Ropivacaine |
| infiltration continues | Active comparator | Not described Receives: Device: The infiltration continues catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption morphinize
the cosumption of morphinize is collected since the first hours of comsumption to the 48 th hours
Measured: 48 hours
Secondary outcomes (1)
Analgesic efficiency
the Score of pain measured by simple numerical rating scales start the first hours one asks for a complementary analgesia to the 48 th hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startFeb 2012
- Primary completionAug 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scheduled Caesarian SectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- loic MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184559
- Sponsor's protocol ID
- 2011-005690-23
- Other IDs
- 2011-38
- Status last verified
- Jul 2014
- First submitted
- 25 Jun 2014
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia After Caesarean Section Under ALR: TAP Block Versus Catheter Scar Infiltration
- ClinicalTrials.gov ID
- NCT02184559
- Acronym / sponsor ID
- 2011-005690-23
- Conditions
- Scheduled Caesarian Section
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 9 Jul 2014 (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 purpose of the multimodal postoperative analgesia is to improve the quality of analgesia and reduce side effects of morphine (nausea, vomiting, sedation, urinary retention, respiratory depression ...). In the case of caesarean sections, the quality of analgesia allows one hand to improve the mother-child relationship and the quality of breastfeeding, the other to reduce the risk of postpartum depression and chronic pain . Two methods of administration of local anesthetics have been proven effective for analgesia of the abdominal wall under umbilical: The Transversus Abdominal Block Plan (TAP Block) and infiltration of the scar continues operating. The TAP block was performed under ultrasound guidance by the anesthesiologist after the intervention in a single injection of local anesthetic in the abdominal wall and has a period of limited and variable. The infiltration continues catheter is placed by the surgeon before closing the wound and allows the infusion of local anesthetics for 48 hours.
The purpose of this study was to compare morphine consumption between both techniques, and the quality of analgesia and side effects of morphine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block | Experimental | Drug: Ropivacaine |
| infiltration continues | Active comparator | Device: The infiltration continues catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Woman whose age is 18 years
- Encircled Woman requiring a scheduled(programmed) caesarian, under spinal anesthesia or died combined(organized) spinal anesthesia
- Woman ASA I and II
- Term = 37 LIMITED COMPANIES
- Woman primipare or not
Key exclusion criteria (9 listed)
- Minor Woman
- Woman presenting a contraindication to the anesthesia périmédullaire: constitutional or acquired disorders(confusions) of the haemostasis, the allergy in the local anesthetics, the infectious context (hypertherm > 38.5 ° C)
- Woman presenting an intolerance or an allergy known about the morphine in the paracetamol or in AIN
- The surgical histories of laparotomy
- The morbid obesity BMI > 35
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 |
|---|---|---|
| Ropivacainecomparaison of two methods of administration for analgesia using the same drugs in the same indication after Caesarean section | Drug | TAP block |
| The infiltration continues catheter | Device | infiltration continues |
Primary outcome
Consumption morphinize
Time frame: 48 hours
the cosumption of morphinize is collected since the first hours of comsumption to the 48 th hours
1 secondary outcome
Analgesic efficiency
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
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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.
aurelie BOURGOIN contact
loic MONDOLONI study director
Assistance Publique Hopitaux De Marseille
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 Ropivacaine and The infiltration continues catheter in people with Scheduled Caesarian Section, run by Assistance Publique Hopitaux De Marseille 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 9 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: status not confirmed, as of the sponsor's last update on 9 Jul 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact aurelie BOURGOIN (aurelie.bourgoin@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consumption morphinize (time frame: 48 hours). 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 Jul 2014.