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Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort

This study is currently recruiting participants.
Verified March 2012 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Chris Wambi, Columbia University
ClinicalTrials.gov Identifier:
NCT01565512
First received: March 26, 2012
Last updated: March 27, 2012
Last verified: March 2012
History of Changes

March 26, 2012
March 27, 2012
December 2011
September 2012   (final data collection date for primary outcome measure)
pain/discomfort [ Time Frame: postoperative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01565512 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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

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.

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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Prostate Cancer
  • Robotic Prostatectomy
  • Foley Catheter Discomfort
  • Drug: 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.
  • Drug: 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.
  • Placebo Comparator: saline injection
    saline injection
    Intervention: Drug: Saline
  • Active Comparator: Bupivacaine injection
    penile block with bupivacaine
    Intervention: Drug: Bupivacaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 40 years and above,
  • diagnosis of prostate cancer,
  • electing to undergo robot-assisted radical prostatectomy

Exclusion Criteria:

  • allergy to bupivacaine or amide-type local anesthetics,
  • chronic pain condition,
  • recently or currently on narcotics,
  • genital abnormalities
Male
40 Years to 80 Years
No
Contact: Chris O. Wambi, M.D. (212)305-9722 cow2101@columbia.edu
Contact: William T. Berg (212)305-6667 wtb2106@gmail.com
United States
 
NCT01565512
AAAI5060
Yes
Chris Wambi, Columbia University
Columbia University
Not Provided
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
Columbia University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP