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Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort

Primary Purpose

Prostate Cancer, Robotic Prostatectomy, Foley Catheter Discomfort

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Saline
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring randomized trial, robotic prostatectomy, prostate cancer, foley catheter discomfort

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • New York Presbyterian Hospital/Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

saline injection

Bupivacaine injection

Arm Description

saline injection

penile block with bupivacaine

Outcomes

Primary Outcome Measures

Prevalence of pain/discomfort

Secondary Outcome Measures

Full Information

First Posted
March 26, 2012
Last Updated
March 3, 2015
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT01565512
Brief Title
Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort
Official Title
Randomized Trial to Determine the Effect of Dorsal Penile Block on Post-Robotic Prostatectomy Foley Discomfort
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding, PI left the institution, poor enrollment
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Robotic Prostatectomy, Foley Catheter Discomfort
Keywords
randomized trial, robotic prostatectomy, prostate cancer, foley catheter discomfort

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
saline injection
Arm Type
Placebo Comparator
Arm Description
saline injection
Arm Title
Bupivacaine injection
Arm Type
Active Comparator
Arm Description
penile block with bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of pain/discomfort
Time Frame
postoperative

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ketan K. Badani, M.D.
Organizational Affiliation
Assistant Professor, Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris O. Wambi, M.D.
Organizational Affiliation
Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mitchell C. Benson, M.D.
Organizational Affiliation
Professor and Chairman, Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
New York Presbyterian Hospital/Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort

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