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Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort

Phase 1
Withdrawn
Conditions
Prostate Cancer
Robotic Prostatectomy
Foley Catheter Discomfort
Interventions
Drug: Saline
Registration Number
NCT01565512
Lead Sponsor
Columbia University
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
Male
Target Recruitment
Not specified
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
saline injectionSalinesaline injection
Bupivacaine injectionBupivacainepenile block with bupivacaine
Primary Outcome Measures
NameTimeMethod
Prevalence of pain/discomfortpostoperative
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

New York Presbyterian Hospital/Columbia University

🇺🇸

New York, New York, United States

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