Impact of a Strategy Combining Morphine Savings and Anesthesia Technique on the Quality of Post-operative Rehabilitation (REHACESAR)

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

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.

Study Overview

• Status: Terminated
• Conditions: Cesarean Section Complications

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.

• Study Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• France
  • Metz, France, 57085
    • CHR Metz-Thionville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the QOR-15 D1 post-caesarean score between six different groups	The QoR 15 score is a score of 15 items, each scored from 0 to 10. These items assess 5 dimensions of post-operative recovery: pain, physical comfort, functional autonomy, emotions and psychological support. These 15 items represent the quality of post-operative rehabilitation in its physical and mental dimensions	day1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between the different anesthesia groups of the post-operative period before resumption of gastrointestinal transit.	The corresponding criterion will be the time in hours between surgery and the resumption of a gas transit	day 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Julien Nadaud, CHR Metz Thionville

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2019
• Primary Completion (ACTUAL): July 1, 2021
• Study Completion (ACTUAL): July 1, 2021

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (ACTUAL): May 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: anesthesia; cesarean
• Other Study ID Numbers: 2018-09Obs-CHRMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No