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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01877356 |
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Date of registration:
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29/03/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparative Study Between Bilateral and Unilateral Spinal Anaesthesia
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Scientific title:
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Unilateral Versus Bilateral Spinal Anesthesia in Day Case Procedures: Difference in Block Characteristics, Micturition Quality and Discharge Time |
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Date of first enrolment:
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December 2012 |
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Target sample size:
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25 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01877356 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Marcel Vercauteren, professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Antwerp |
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Name:
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margaretha breebaart, md |
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Address:
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Telephone:
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Email:
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Affiliation:
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senior member of staff department anaesthesiology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- spinal anaesthesia
- surgery<60 minutes
Exclusion Criteria:
- preexisting micturition problems
- surgery lower abdomen/pelvis
- bmi>30
- mental problems
- kidney disease
- neurologic disease
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Anesthesia; Adverse Effect, Spinal and Epidural
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Intervention(s)
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Procedure: bilateral spinal anesthesia
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Procedure: unilateral spinal anesthesia
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Primary Outcome(s)
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discharge time ( minutes)
[Time Frame: up to 360 minutes]
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regression motor block
[Time Frame: up to 240 minutes]
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time to micturition (minutes)
[Time Frame: up to 360 minutes]
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Secondary Outcome(s)
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drop blood pressure
[Time Frame: up to 240 minutes]
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incidence transient neurologic symptoms
[Time Frame: 1 week]
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Secondary ID(s)
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B300-2012-15-548
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study B300201215548
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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