Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort

March 3, 2015 updated by: Columbia University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of pain/discomfort
Time Frame: postoperative
postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

March 26, 2012

First Submitted That Met QC Criteria

March 27, 2012

First Posted (ESTIMATE)

March 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 3, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAI5060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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