Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-23
Brief Title:
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
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Superiority Randomized Double-blind Controlled Trial of Epidural Magnesium Sulfate Addition Versus Placebo on the Occurrence of Acute Post-caesarean Urinary Retention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIMAG
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
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
Detailed Description:
The main objective of this study is to evaluate the efficacy of the addition of epidural magnesium sulfate in reducing the occurrence of acute post-Caesarean urine retention
In fact the incidence of acute urine retention after epidural anaesthesia for Caesarean section is around 33 Two encouraging studies suggest that adding magnesium sulfate to epidurals could reduce the incidence of acute urine retention by 15
This study will be carried out on the obstetric population of the REIMS maternity hospital starting in summer 2024 It is a randomized double-blind placebo-controlled clinical trial The number of subjects required is calculated at 290 patients with a power of 80 and an alpha risk of 5 The statistical hypothesis is that magnesium sulfate reduces the incidence of acute urine retention by 15 compared with placebo isotonic saline
Parturients will be informed of the study during a pre-anaesthetic consultation in the 6th month of pregnancy
Some of these patients will be scheduled for delivery by caesarean section The remaining patients will be scheduled for a vaginal delivery which may end up being an emergency caesarean section 10-15 of patients
After the Caesarean section patients are taken to the post-procedure monitoring room where they are monitored for 2 hours
It is at this point that patients are examined to verify the inclusion and non-inclusion criteria of the protocol If the inclusion and non-inclusion criteria are met our teams will provide patients with explanatory documents on our protocol as well as a consent form for their signature
When the patient agrees to enter the protocol the investigators randomize her to one of the following groups
Group A injection of morphine 2 mg into the epidural catheter magnesium sulfate 500 mg
Group B injection of morphine 2 mg into the epidural catheter isotonic saline
Group B is the control group This is the protocol we use in daily practice for parturients who have undergone Caesarean section in line with the French recommendations of anesthesia societies
This reduces the parturients postoperative pain for 20-24 hours Group A will be the experimental group Patients will be monitored in the post-natal care unit for 72 hours The investigators will carry out the same monitoring and care as a parturient outside the protocol Various data on diuresis the quantity of urine in the bladder visualized by ultrasound and the need for urinary catheterization will be recorded
Statistical analyses will determine whether the incidence of acute urine retention differs between each group
In fact the incidence of acute urine retention after epidural anaesthesia for Caesarean section is around 33 Two encouraging studies suggest that adding magnesium sulfate to epidurals could reduce the incidence of acute urine retention by 15
This study will be carried out on the obstetric population of the REIMS maternity hospital starting in summer 2024 It is a randomized double-blind placebo-controlled clinical trial The number of subjects required is calculated at 290 patients with a power of 80 and an alpha risk of 5 The statistical hypothesis is that magnesium sulfate reduces the incidence of acute urine retention by 15 compared with placebo isotonic saline
Parturients will be informed of the study during a pre-anaesthetic consultation in the 6th month of pregnancy
Some of these patients will be scheduled for delivery by caesarean section The remaining patients will be scheduled for a vaginal delivery which may end up being an emergency caesarean section 10-15 of patients
After the Caesarean section patients are taken to the post-procedure monitoring room where they are monitored for 2 hours
It is at this point that patients are examined to verify the inclusion and non-inclusion criteria of the protocol If the inclusion and non-inclusion criteria are met our teams will provide patients with explanatory documents on our protocol as well as a consent form for their signature
When the patient agrees to enter the protocol the investigators randomize her to one of the following groups
Group A injection of morphine 2 mg into the epidural catheter magnesium sulfate 500 mg
Group B injection of morphine 2 mg into the epidural catheter isotonic saline
Group B is the control group This is the protocol we use in daily practice for parturients who have undergone Caesarean section in line with the French recommendations of anesthesia societies
This reduces the parturients postoperative pain for 20-24 hours Group A will be the experimental group Patients will be monitored in the post-natal care unit for 72 hours The investigators will carry out the same monitoring and care as a parturient outside the protocol Various data on diuresis the quantity of urine in the bladder visualized by ultrasound and the need for urinary catheterization will be recorded
Statistical analyses will determine whether the incidence of acute urine retention differs between each group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None