NCT05042817

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

August 16, 2021

Last Update Submit

March 15, 2023

Conditions

Analgesia

Keywords

ObstreticsRegional anesthesiaInjectionsSpinalAnalgesicsOpioid

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Bladder re-catherization

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

Study Arms (2)

Morphine

ACTIVE COMPARATOR

50 mg prilocaine + 2.5 mcg sufentanil + 100 mcg morphine (0.1ml)

Drug: 100 mcg morphineDrug: 50 mg prilocaine + 2.5 mcg sufentanil

NaCl 0.9%

PLACEBO COMPARATOR

50 mg prilocaine + 2.5 mcg sufentanil + 0.1 ml saline

Drug: 0.9% NaClDrug: 50 mg prilocaine + 2.5 mcg sufentanilProcedure: bilateral transverse abdominal plane block

Interventions

100 mcg morphineDRUG

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

Morphine
0.9% NaClDRUG

NaCl 0.9%

NaCl 0.9%
50 mg prilocaine + 2.5 mcg sufentanilDRUG

50 mg prilocaine + 2.5 mcg sufentanil

MorphineNaCl 0.9%
bilateral transverse abdominal plane blockPROCEDURE

20 mL of ropicavaine 0.375% on each side

Also known as: TAP block
NaCl 0.9%

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women with term singleton pregnancies are included, therefore males cannot be included
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I and II
  • Term singleton pregnancies
  • Elective cesarean delivery under spinal anesthesia
  • Between October 2021 and March 2022

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Liege, University Hospital

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Agnosia

Interventions

MorphineSaline SolutionPrilocaineSufentanil

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesFentanylPiperidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Patient assessments and bladder urodynamic data collection were performed by two blinded anesthesiologists. Randomization 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. Another two blinded anesthesiologists administered perioperative anesthesia and monitored the patient during the perioperative period, and evaluated sensitive and motor block.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 16, 2021

First Posted

September 13, 2021

Study Start

October 1, 2021

Primary Completion

March 31, 2022

Study Completion

December 31, 2022

Last Updated

March 20, 2023

Record last verified: 2023-03

Locations

BE(1)