Superiority Randomized Double-blind Controlled Trial of Epidural Magnesium Sulfate Addition Versus Placebo on the Occurrence of Acute Post-caesarean Urinary Retention

What this Trial Is About

Researchers are evaluating the addition of magnesium sulfate to epidural morphine to reduce the occurrence of acute urinary retention after Caesarean section. Acute urinary retention affects about one-third of women after this surgery and can lead to complications like catheterization, urinary infections, and delayed recovery. This phase 4 trial is a randomized, double-blind, placebo-controlled study conducted at Reims University Hospital, aiming to clarify the potential benefit of magnesium sulfate in this setting. Participants will be randomly assigned after Caesarean section to receive either 2 mg morphine plus 500 mg magnesium sulfate or 2 mg morphine plus isotonic saline injected into the epidural space. The control group receives standard care with morphine and saline, while the experimental group receives morphine and magnesium sulfate. Patients are monitored in the post-natal care unit for 72 hours, with data collected on urine output, bladder volume by ultrasound, and the need for catheterization. During the study, patients are assessed after surgery in the monitoring room and followed for three days. Researchers will collect information about urination, bladder volume, and catheter use to compare the groups. The main outcome is urine output measured over 72 hours. Safety and other routine care are maintained throughout. The trial is planned to start in early 2025 and continue until late 2027, with 290 participants enrolled to detect a 15% reduction in urinary retention with magnesium sulfate.

Evaluation of the Efficacy of the Addition of Magnesium Sulfate to Morphine on the Occurrence of Acute Urinary Retention Following Epidural Anesthesia for Cesarean Section.