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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • University of Liege, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Opioid; Injections; Spinal; Regional anesthesia; Analgesics; Obstretics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Prilocaine; Morphine; Sufentanil
• Other Study ID Numbers: VesicalMorphine

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No