Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort

NCT ID: NCT01565512

Last Updated: 2015-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-07-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer Robotic Prostatectomy Foley Catheter Discomfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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saline injection

saline injection

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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.

Bupivacaine injection

penile block with bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ketan K. Badani, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Chris O. Wambi, M.D.

Role: STUDY_CHAIR

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

Mitchell C. Benson, M.D.

Role: STUDY_DIRECTOR

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

Locations

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New York Presbyterian Hospital/Columbia University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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AAAI5060

Identifier Type: -

Identifier Source: org_study_id

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