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Completed

NCT Number: NCT05042817

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

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.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Liege, University Hospital

Liège, 4000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

100 mcg morphine

Drug

The effect of intrathecal morphine on vesical function and the need for bladder re-catheterization after a cesarean delivery

0.9% NaCl

Drug

NaCl 0.9%

50 mg prilocaine + 2.5 mcg sufentanil

Drug

50 mg prilocaine + 2.5 mcg sufentanil

bilateral transverse abdominal plane block

Procedure

20 mL of ropicavaine 0.375% on each side

Other names: TAP block

Primary outcomes

  1. First micturition (hours)

    Time frame: until the end of the study, an average of 6 months

    Vesicle function 1

  2. Bladder volume (mL)

    Time frame: until the end of the study, an average of 6 months

    Vesicle function 2

  3. Debimetry

    Time frame: until the end of the study, an average of 6 months

    Vesicle function 3

Secondary outcomes

  1. Bladder re-catherization

    Time frame: until the end of the study, an average of 6 months

    Vesicle function 4

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 13, 2021
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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