Clinical trial

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

Name

VesicalMorphine

Description

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.

Trial arms

Trial start

2021-10-01

Estimated PCD

2022-03-31

Trial end

2022-12-31

Status

Completed

Treatment

100 mcg morphine

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

Arms:

Morphine

0.9% NaCl

NaCl 0.9%

Arms:

NaCl 0.9%

50 mg prilocaine + 2.5 mcg sufentanil

Arms:

Morphine, NaCl 0.9%

bilateral transverse abdominal plane block

20 mL of ropicavaine 0.375% on each side

Arms:

NaCl 0.9%

Other names:

TAP block

Size

Primary endpoint

First micturition (hours)

until the end of the study, an average of 6 months

Bladder volume (mL)

until the end of the study, an average of 6 months

Debimetry

until the end of the study, an average of 6 months

Eligibility criteria

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Patient assessments and bladder urodynamic data collection were performed by two blinded anesthesiologists.\n\nRandomization was performed using the sealed envelopes method. Therefore, one of the anesthesiologists of the research team, who was unblinded, opened the envelopes and prepared the injection mixtures.\n\nAnother two blinded anesthesiologists administered perioperative anesthesia and monitored the patient during the perioperative period, and evaluated sensitive and motor block.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 56, 'type': 'ACTUAL'}}

Updated at

2023-03-20

1 organization

2 products

1 drug

1 indication

Organization

Product

Indication

Drug

Product

50 mg Prilocaine + 2.5 mcg Sufentanil