Effect of Intrathecal Morphine on Urinary Bladder Function and Recovery in Patients Having a Cesarean Delivery

Study Overview
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Brief Summary
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The enhanced recovery anesthesia concept has been widely adopted, including cesarean delivery. Modern obstetrical anesthesia aims to offer an experience to a patient undergoing a cesarean delivery similar to normal vaginal delivery in order to maximize postoperative comfort and facilitate bonding between the mother and her newborn. Therefore, early removal of the bladder catheter has been recommended. However, this is challenged by the administration of intrathecal morphine recommended to provide long-lasting postoperative analgesia after cesarean delivery.

Detailed Description
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This double-blind, randomized trial investigates the effects of intrathecal morphine on urinary dynamics in women undergoing CD under spinal anesthesia. The hypothesis is that the addition of intrathecal morphine (ITM) will delay micturition in women undergoing cesarean delivery. The primary outcome is the effect of ITM on urodynamics the difference in time to micturition. The secondary outcome is the need for bladder re-catheterization.

Official Title
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Effect of Intrathecal Morphine on Urinary Bladder Function and Recovery in Patients Having a Cesarean Delivery - A Double-blind Randomized Clinical Trial

Conditions
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Analgesia

Intervention / Treatment
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* Drug: 100 mcg morphine
* Drug: 0.9% NaCl
* Drug: 50 mg prilocaine + 2.5 mcg sufentanil
* Procedure: bilateral transverse abdominal plane block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I and II Term singleton pregnancies Elective cesarean delivery under spinal anesthesia Between October 2021 and March 2022 Exclusion Criteria: Pre-existing or gestational hypertension Diabetes Cardiovascular disease Cerebrovascular disease Known fetal abnormalities Extremes of weight (<40 kg or > 100 kg) Contraindications to neuraxial anesthesia Twin pregnancies Excessive intraoperative bleeding (blood loss exceeding > 1000 mL or requiring a blood transfusion)

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Morphine<br>50 mg prilocaine + 2.5 mcg sufentanil + 100 mcg morphine (0.1ml) | Drug: 100 mcg morphine<br>* The effect of intrathecal morphine on vesical function and the need for bladder re-catheterization after a cesarean delivery<br>Drug: 50 mg prilocaine + 2.5 mcg sufentanil<br>* 50 mg prilocaine + 2.5 mcg sufentanil<br>|
| Placebo Comparator: NaCl 0.9%<br>50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline | Drug: 0.9% NaCl<br>* NaCl 0.9%<br>Drug: 50 mg prilocaine + 2.5 mcg sufentanil<br>* 50 mg prilocaine + 2.5 mcg sufentanil<br>Procedure: bilateral transverse abdominal plane block<br>* 20 mL of ropicavaine 0.375% on each side<br>* Other names: TAP block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First micturition (hours) | Vesicle function 1 | until the end of the study, an average of 6 months | 
| Bladder volume (mL) | Vesicle function 2 | until the end of the study, an average of 6 months | 
| Debimetry | Vesicle function 3 | until the end of the study, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder re-catherization | Vesicle function 4 | until the end of the study, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstretics, Regional anesthesia, Injections, Spinal, Analgesics, Opioid