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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 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2025-12-30

No results posted yet for this 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

Conditions

  • Urinary Retention

Interventions

DRUG

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

DRUG

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

Sponsors & Collaborators

  • CHU de Reims

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-16
Primary Completion
2027-07-31
Completion
2027-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06442995 on ClinicalTrials.gov