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 | Recruiting Phase 4

• 1 other identifier: PO24038*
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• diuresis

  72 hours

Study Arms (2)

Magnesium Sulfate

EXPERIMENTAL

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

Drug: Injection of 500 mg magnesium sulfate + 2 mg morphine into the epidural space

Isotonic saline

PLACEBO COMPARATOR

Injection of Isotonic saline + 2 mg morphine into the epidural space

Drug: Injection of Isotonic saline + 2 mg morphine into the epidural space

Interventions

Injection of 500 mg magnesium sulfate + 2 mg morphine into the epidural space DRUG

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

Magnesium Sulfate

Injection of Isotonic saline + 2 mg morphine into the epidural space DRUG

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

Isotonic saline

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

MeSH Terms

Conditions

Urinary Retention

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Maxime Riffault

CONTACT

00336 79 63 29 55; mriffault@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 5, 2024
• Study Start: January 16, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

FR (1)