Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort

Columbia University

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Foley Catheter Discomfort; Robotic Prostatectomy; Prostate Cancer

Treatments: Drug: Bupivacaine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01565512

AAAI5060

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 40 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

saline injection

Placebo Comparator group

Description:

saline injection

Treatment:

Drug: Saline

Bupivacaine injection

Active Comparator group

Description:

penile block with bupivacaine

Treatment:

Drug: Bupivacaine