IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia

Study Overview
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Brief Summary
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The aim of this study is to assess the efficacy of IM neostigmine (0.5 mg) for acceleration of bladder evacuation and prevention of postoperative urine retention following cesarean delivery carried out under spinal anesthesia

Detailed Description
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Following cesarean delivery, women will receive either 0.5 mg IM neostigmine (study group) or IM NaCl 0.9% (control group). Bladder ultrasonography will be done every hour until spontaneous voiding occurs. If postoperative urine retention occurred (void inability with bladder volume > 600 ml by ultrasound), urinary catheterization will be done.

Official Title
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Intramuscular Neostigmine for Accelerating Bladder Emptying After Cesarean Section by Spinal Anesthesia

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Drug: Neostigmine
* Drug: NaCl 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women undergoing elective cesarean deliver under spinal anesthesia. Exclusion Criteria: The age of the patient is more than 35 years of less than 20 years. The body mass index of the patient is more than 35 kg/m2 or her height is more than 180 cm or less than 150 cm. Multiple gestation. The patient is in active labor. Vaginal bleeding, placenta previa or abruption of the placenta. Presence of fetal distress. Urinary symptoms. Medical disorders co-existing with or complicating pregnancy. Contraindications for or history of adverse reaction of Neostigmine. Contraindication for spinal anesthesia. Refusal of the patient to receive spinal anesthesia. Intraoperative significant hemorrhage. Duration of the operation is more than one hour. Occurrence of postoperative complications as eclampsia.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neostigmine group<br>After cesarean delivery, women will receive 0.5 mg IM neostigmine | Drug: Neostigmine<br>* Participants will receive 0.5 mg IM neostigmine<br>* Other names: Epistigmin;|
| Placebo Comparator: Placebo group<br>After cesarean delivery, women will receive IM NaCl 0.9% as a placebo | Drug: NaCl 0.9%<br>* Participants will receive IM NaCl 0.9% as a placebo<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first voiding after treatment | Time interval between IM injection of neostigmine or NaCl and occurrence of first voiding | Until 12 hours postoperatively | 
| Time to first voiding after catheter removal | Time interval between catheter removal and occurrence of first voiding | Until 12 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean Section, Spinal anesthesia, Postoperative urine retention (POUR)