Impact of a Strategy Combining Morphine Savings and Anesthesia Technique on the Quality of Post-o… (NCT04377984) | Clinical Trial Compass
TerminatedNot Applicable
Impact of a Strategy Combining Morphine Savings and Anesthesia Technique on the Quality of Post-operative Rehabilitation
Stopped: Because of health context as well as the implementation of the RAAC caesarean section, which means that patients enter in the morning, and it is therefore no longer possible to do the QOR on D-1 and therefore to include scheduled caesarean sections
France145 participantsStarted 2019-09-09
Plain-language summary
The aim of REHACESAR is to study the impact of an association of a low dose of neuraxial morphine and a locoregional anesthesia (TAP block or catheter for continuous wound infiltration) on quality of recovery after cesarean delivery under regional anesthesia.
To assess the quality of recovery, women complete the self-questionnaire Quality Of Recovery (QOR)15 on D-1 (the day before cesarean, if elective), D+1, +2 and +3 after surgery.
The QOR-15 is a 15 items questionnaire which provides a valid and efficient evaluation of the postoperative quality of recovery.
REHACESAR is a prospective observational study. It takes place in the maternity of the CHR Metz-Thionville hospital.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pregnant woman,
* operated on a scheduled cesarean under spinal anesthesia or urgent under epidural anesthesia, with use of perimedullary morphine
Exclusion Criteria:
* Contraindication to the use of morphine
* Contraindication to local anesthetics
* Urgent cesarean section for maternal pathology: preeclampsia (PE), eclampsia, HELLP syndrome
* Post-operative maternal transfer
* Preoperative opiate treatment
* Patient unable to understand and / or answer a questionnaire in French
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of the QOR-15 D1 post-caesarean score between six different groups