Clinical trial NCT04377984: Impact of a Strategy Combining Morphine Savings and Anesthesia Technique on the Quality of Post-operative Rehabilitation
Official title: Impact of a Strategy Combining Morphine Savings and a Loco-regional Anesthesia Technique on the Quality of Post-operative Rehabilitation of Cesareans Performed Under Peri-spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cesarean Section Complications
Keywords: cesarean
anesthesia
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant woman operated on a scheduled cesarean under spinal anesthesia or urgent under epidural anesthesia, with use of perimedullary morphine

Brief 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.

Detailed description: Cesarean delivery is a very frequent surgical procedure. In France 20,4% of all births occur by cesarean section. Regional anesthesia (Spinal or epidural anesthesia) is the most common type of anesthesia for emergent or elective cesarean section.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the QOR-15 D1 post-caesarean score between six different groups
timeFrame: day1
Secondary outcomes:
measure: Comparison between the different anesthesia groups of the post-operative period before resumption of gastrointestinal transit.
timeFrame: day 3
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville
Study officials:
affiliation: CHR Metz Thionville
name: Julien Nadaud
role: PRINCIPAL_INVESTIGATOR
References: