Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort
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.
Foley Catheter Discomfort
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Trial to Determine the Effect of Dorsal Penile Block on Post-Robotic Prostatectomy Foley Discomfort|
- Prevalence of pain/discomfort [ Time Frame: postoperative ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: saline injection
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.
Active Comparator: Bupivacaine injection
penile block with 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.
Patients undergoing robot-assisted radical prostatectomy (RARP) will be randomized in a double-blind placebo controlled manner to undergo penile ring block injection at the time of skin incision closure. A visual analog scale (VAS) based questionnaire including newly developed foley discomfort scores will be administered at various time points post-operatively.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565512
|United States, New York|
|New York Presbyterian Hospital/Columbia University|
|New York, New York, United States, 10032|
|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|