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

NCT04377984 | Terminated

• 1 other identifier: 2018-09Obs-CHRMT
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Keywords

cesarean; anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison between the different anesthesia groups of the post-operative period before resumption of gastrointestinal transit.

  day 3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Pregnant woman,
• operated on a scheduled cesarean under spinal anesthesia or urgent under epidural anesthesia, with use of perimedullary morphine

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville

Metz, 57085, France

Location

Study Officials

• Julien Nadaud

  CHR Metz Thionville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: September 9, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: January 28, 2022

Record last verified: 2021-09

Locations

FR (1)