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Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort

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ClinicalTrials.gov Identifier: NCT01565512
Recruitment Status : Withdrawn (Lack of funding, PI left the institution, poor enrollment)
First Posted : March 28, 2012
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial to Determine the Effect of Dorsal Penile Block on Post-Robotic Prostatectomy Foley Discomfort
Study Start Date : November 2011
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Prevalence of pain/discomfort [ Time Frame: postoperative ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565512


Locations
United States, New York
New York Presbyterian Hospital/Columbia University
New York, New York, United States, 10032
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

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01565512     History of Changes
Other Study ID Numbers: AAAI5060
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015

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

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