Study Stopped
Lack of funding, PI left the institution, poor enrollment
Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort
Randomized Trial to Determine the Effect of Dorsal Penile Block on Post-Robotic Prostatectomy Foley Discomfort
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The indwelling urethral foley is a major source of discomfort following radical prostatectomy. Our hypothesis is that intra-operative dorsal penile nerve block with bupivacaine may decrease immediate post-operative foley discomfort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2011
1 active site
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
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 26, 2012
CompletedFirst Posted
Study publicly available on registry
March 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedMarch 5, 2015
March 1, 2015
2.7 years
March 26, 2012
March 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of pain/discomfort
postoperative
Study Arms (2)
saline injection
PLACEBO COMPARATORsaline injection
Bupivacaine injection
ACTIVE COMPARATORpenile block with bupivacaine
Interventions
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.
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
You may qualify if:
- age 40 years and above,
- diagnosis of prostate cancer,
- electing to undergo robot-assisted radical prostatectomy
You may not qualify if:
- allergy to bupivacaine or amide-type local anesthetics,
- chronic pain condition,
- recently or currently on narcotics,
- genital abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York Presbyterian Hospital/Columbia University
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ketan K. Badani, M.D.
Assistant Professor, Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
- STUDY CHAIR
Chris O. Wambi, M.D.
Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
- STUDY DIRECTOR
Mitchell C. Benson, M.D.
Professor and Chairman, Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2012
First Posted
March 28, 2012
Study Start
November 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
March 5, 2015
Record last verified: 2015-03