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

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Drug: 100 mcg morphine; Drug: 0.9% NaCl; Drug: 50 mg prilocaine + 2.5 mcg sufentanil; Procedure: bilateral transverse abdominal plane block

• Registration Number: NCT05042817
• Lead Sponsor: University of Liege

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-09-06
• Study First Posted: 2021-09-13
• Study Start: 2021-10-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl 0.9%	50 mg prilocaine + 2.5 mcg sufentanil	50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline
Morphine	100 mcg morphine	50 mg prilocaine + 2.5 mcg sufentanil + 100 mcg morphine (0.1ml)
Morphine	50 mg prilocaine + 2.5 mcg sufentanil	50 mg prilocaine + 2.5 mcg sufentanil + 100 mcg morphine (0.1ml)
NaCl 0.9%	0.9% NaCl	50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline
NaCl 0.9%	bilateral transverse abdominal plane block	50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline

Primary Outcome Measures

Name	Time	Method
First micturition (hours)	until the end of the study, an average of 6 months	Vesicle function 1
Debimetry	until the end of the study, an average of 6 months	Vesicle function 3
Bladder volume (mL)	until the end of the study, an average of 6 months	Vesicle function 2

Secondary Outcome Measures

Name	Time	Method
Bladder re-catherization	until the end of the study, an average of 6 months	Vesicle function 4

Trial Locations

Locations (1)

University of Liege, University Hospital; 🇧🇪 Liège, Belgium