Know Cancer

or
forgot password

Randomized Trial to Determine the Effect of Dorsal Penile Block on Post-Robotic Prostatectomy Foley Discomfort


Phase 1/Phase 2
40 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer, Robotic Prostatectomy, Foley Catheter Discomfort

Thank you

Trial Information

Randomized Trial to Determine the Effect of Dorsal Penile Block on Post-Robotic Prostatectomy 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

pain/discomfort

Outcome Time Frame:

postoperative

Safety Issue:

No

Principal Investigator

Ketan K. Badani, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistant Professor, Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

AAAI5060

NCT ID:

NCT01565512

Start Date:

December 2011

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Robotic Prostatectomy
  • Foley Catheter Discomfort
  • randomized trial
  • robotic prostatectomy
  • prostate cancer
  • foley catheter discomfort
  • Prostatic Neoplasms

Name

Location

New York Presbyterian Hospital/Columbia UniversityNew York, New York  10032