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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Chu Reims
RECRUITING
Reims
Contact Information
Primary
Maxime Riffault
mriffault@chu-reims.fr
00336 79 63 29 55
Time Frame
Start Date: 2025-01-16
Estimated Completion Date: 2027-12
Participants
Target number of participants: 290
Treatments
Experimental: Magnesium Sulfate
Injection of 500 mg magnesium sulfate + 2 mg morphine into the epidural space
Placebo_comparator: Isotonic saline
Injection of Isotonic saline + 2 mg morphine into the epidural space
Sponsors
Leads: CHU de Reims

This content was sourced from clinicaltrials.gov