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.

NCT06442995 · tracked via the Priya Life Science France tracker

Sponsor

CHU de Reims

Phase

Phase 4

Started

2025-01-16

Last updated

2025-12-30

Condition(s) studied

Urinary Retention

Investigational drug(s) / intervention(s)

Injection of 500 mg magnesium sulfate + 2 mg morphine into the epidural space →Injection of Isotonic saline + 2 mg morphine into the epidural space

Injection of 500 mg magnesium sulfate + 2 mg morphine into the epidural space: When the patient agrees to enter the protocol, the investigators randomize the patient and proceed to the injection of morphine 2 mg into the epidural catheter + magnesium sulfate 500 mg

Injection of Isotonic saline + 2 mg morphine into the epidural space: When the patient agrees to enter the protocol, the investigators randomize the patient and proceed to Injection of morphine 2 mg into the epidural catheter + isotonic saline. This is the protocol the investigators use in daily practice for parturients who have undergone Caesarean section, in line with the French recommendations of anesthesia societies

Study summary

Peri-medullary anesthesia is the preferred anesthetic technique for Caesarean surgery. Compared with general anesthesia, it reduces maternal and fetal morbidity and mortality, as well as postoperative pain. However, this technique exposes the patient to the adverse effects of peri-medullary morphine, particularly the risk of postoperative urinary retention. Urinary retention during the first 72 hours after Caesarean section affects around 33% of parturients.

This is a particularly debilitating event for parturients, exposing them to the risk of further urinary catheterization, increased theoretical risk of urinary tract infection, traumatic urethral injury, hindered accelerated rehabilitation and altered maternal satisfaction.

Several studies have demonstrated the benefits of adding magnesium sulfate to epidural anesthesia for Caesarean sections, notably by reducing postoperative pain.

Magnesium sulfate may also have a facilitating effect on postoperative micturition, thanks to its sympathicolytic effect.

This hypothesis is supported by a retrospective study carried out in our maternity hospital, which showed a 15% reduction in post-Caesarean urinary retention when women were given magnesium sulfate in addition to the drugs traditionally used for epidurals.

This little-known property needs to be clarified

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients who have undergone scheduled or emergency Caesarean section surgery under extended epidural anesthesia or combined epidural and spinal anesthesia at the Reims University Hospital. * Patients who have just undergone caesarean section and have the epidural catheter in place in the post-interventional monitoring room (SSPI). * Patients who agree to take part in the research and have signed the informed consent form * Patients of legal age * Patients affiliated to a social security scheme Exclusion Criteria: * Minor patients * Patients protected by law * Patients allergic to local anesthetics, morphine or magnesium sulfate * Patients with severe renal insufficiency (GFR \< 30 ml/min) * Patients with pre-pregnancy mictional disorders * Patients with an American Society of Anesthesiologists (ASA) score of 4 * Patients undergoing caesarean section under general anaesthesia, after failure of perimedullary anaesthesia * Patients with accidental intraoperative injury to the urinary tract * Patients who have received intravenous magnesium sulfate in the 24 hours preceding cesarean section

Primary outcome measure(s)

diuresis — 72 hours

Trial sites (1)

Facility	City	Region	Status
Chu Reims	Reims	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06442995 on ClinicalTrials.gov ↗ ← All trials in France