Clinical Trials Directory

Trials / Terminated

TerminatedNCT04377984

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

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

Status
Terminated
Phase
Study type
Observational
Enrollment
145 (actual)
Sponsor
Centre Hospitalier Régional Metz-Thionville · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2019-09-09
Primary completion
2021-07-01
Completion
2021-07-01
First posted
2020-05-07
Last updated
2022-01-28

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04377984. Inclusion in this directory is not an endorsement.