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Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort

NCT01565512 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2015-03-05

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Ketan K. Badani, M.D. · Assistant Professor, Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center

  • Chris O. Wambi, M.D. · Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center

  • Mitchell C. Benson, M.D. · Professor and Chairman, Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01565512 on ClinicalTrials.gov