Foley Catheter Discomfort, Prostate Cancer, Robotic Prostatectomy
Conditions
Keywords
randomized trial, robotic prostatectomy, prostate cancer, foley catheter discomfort
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.
Interventions
DRUGBupivacaine
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.
DRUGSaline
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
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of pain/discomfort | postoperative |
Countries
United States
Outcome results
None listed