Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Columbia University.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Robotic Prostatectomy
Foley Catheter Discomfort
Drug: Bupivacaine
Drug: Saline
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • pain/discomfort [ Time Frame: postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: December 2011
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: saline injection
saline injection
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.
Active Comparator: Bupivacaine injection
penile block with bupivacaine
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01565512

Contacts
Contact: Chris O. Wambi, M.D. (212)305-9722 cow2101@columbia.edu
Contact: William T. Berg (212)305-6667 wtb2106@gmail.com

Locations
United States, New York
New York Presbyterian Hospital/Columbia University Recruiting
New York, New York, United States, 10032
Contact: Chris O. Wambi, M.D.    212-305-9722    cow2101@columbia.edu   
Contact: William T. Berg    (212)305-6667    wtb2106@gmail.com   
Sponsors and Collaborators
Columbia University
Investigators
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
  More Information

No publications provided

Responsible Party: Chris Wambi, Fellow, Department of Urology, Columbia University
ClinicalTrials.gov Identifier: NCT01565512     History of Changes
Other Study ID Numbers: AAAI5060
Study First Received: March 26, 2012
Last Updated: March 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Columbia University:
randomized trial
robotic prostatectomy
prostate cancer
foley catheter discomfort

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Bupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014