Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort
NCT ID: NCT01565512
Last Updated: 2015-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2011-11-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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saline injection
saline injection
Saline
A total of 20 mL on injectable saline(0.9% NS) administered once by subcutaneous injection while patient is under general anesthesia at end of operation.
Bupivacaine injection
penile block with bupivacaine
Bupivacaine
A total of 100 mg bupivacaine (20 mL of 5 mg/mL solution) administered once by subcutaneous injection while patient is under general anesthesia at end of operation.
Interventions
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Bupivacaine
A total of 100 mg bupivacaine (20 mL of 5 mg/mL solution) administered once by subcutaneous injection while patient is under general anesthesia at end of operation.
Saline
A total of 20 mL on injectable saline(0.9% NS) administered once by subcutaneous injection while patient is under general anesthesia at end of operation.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of prostate cancer,
* electing to undergo robot-assisted radical prostatectomy
Exclusion Criteria
* chronic pain condition,
* recently or currently on narcotics,
* genital abnormalities
40 Years
80 Years
MALE
No
Sponsors
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Columbia University
OTHER
Responsible Party
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Principal Investigators
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Ketan K. Badani, M.D.
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor, Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
Chris O. Wambi, M.D.
Role: STUDY_CHAIR
Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
Mitchell C. Benson, M.D.
Role: STUDY_DIRECTOR
Professor and Chairman, Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
Locations
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New York Presbyterian Hospital/Columbia University
New York, New York, United States
Countries
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Other Identifiers
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AAAI5060
Identifier Type: -
Identifier Source: org_study_id
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