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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05042817
• Other study ID #: VesicalMorphine
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• 100 mcg morphine
The effect of intrathecal morphine on vesical function and the need for bladder re-catheterization after a cesarean delivery
• 0.9% NaCl
NaCl 0.9%
• 50 mg prilocaine + 2.5 mcg sufentanil
50 mg prilocaine + 2.5 mcg sufentanil

Procedure:
• bilateral transverse abdominal plane block
20 mL of ropicavaine 0.375% on each side

Locations

Country	Name	City	State
Belgium	University of Liege, University Hospital	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First micturition (hours)	Vesicle function 1	until the end of the study, an average of 6 months
Primary	Bladder volume (mL)	Vesicle function 2	until the end of the study, an average of 6 months
Primary	Debimetry	Vesicle function 3	until the end of the study, an average of 6 months
Secondary	Bladder re-catherization	Vesicle function 4	until the end of the study, an average of 6 months