Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01565512
• Other study ID #: AAAI5060
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: March 26, 2012
• Last updated: March 3, 2015
• Start date: November 2011
• Est. completion date: July 2014

Study information

• Verified date: March 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Foley Catheter Discomfort
• Prostate Cancer
• Prostatic Neoplasms
• Robotic Prostatectomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital/Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of pain/discomfort		postoperative	No