Impact of a Strategy Combining Morphine Savings and Anesthesia Technique on the Quality of Post-operative Rehabilitation
NCT ID: NCT04377984
Last Updated: 2022-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
145 participants
OBSERVATIONAL
2019-09-09
2021-07-01
Brief Summary
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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.
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Detailed Description
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HAS guidelines on Enhanced Recovery After Surgery (ERAS) include cesarean section. ERAS is a "multimodal perioperative care pathway designed to achieve early recovery for patients undergoing surgery". The aim is to avoid factors which delay recovery: nausea and vomiting, pain, postoperative ileus…
Postoperative analgesia is a key factor in ERAS because pain may prolong recovery and has a negative impact on rehabilitation. Among the multimodal analgesia we can use neuraxial morphine: epidural or intrathecal. Neuraxial morphine is effective for post-cesarean analgesia. Previous studies have attempted to determine the optimum intrathecal and epidural morphine doses. The aim is to provide the better analgesia with fewer side effects (pruritus, nausea and vomiting, ileus) Another way to provide analgesia is locoregional anesthesia: continuous wound infiltration and Transversus Abdominis Plane Block (TAP) block.
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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* operated on a scheduled cesarean under spinal anesthesia or urgent under epidural anesthesia, with use of perimedullary morphine
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Centre Hospitalier Régional Metz-Thionville
OTHER
Responsible Party
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Principal Investigators
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Julien Nadaud
Role: PRINCIPAL_INVESTIGATOR
CHR Metz Thionville
Locations
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CHR Metz-Thionville
Metz, , France
Countries
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Other Identifiers
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2018-09Obs-CHRMT
Identifier Type: -
Identifier Source: org_study_id
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