NCT02502487

Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

Dorsal Penile Nerve Block for Rigid Cystoscopy in Men: a Single-center, Randomized, Double-blind and Placebo-controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: West China Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will determine the effectiveness and safety of dorsal penile nerve block (DPNB) in men undergoing rigid cystoscopy.

Detailed description

Pain is common in men undergoing rigid cystoscopy. Even with application of a lubricant containing 2% lidocaine, about 76% men suffer from mild to severe pain when undergoing rigid cystoscopy, and approximately 27% men could still feel mild to moderate pain 7 days after the procedure. The most painful part of the procedure for men is when the cystoscope passes through the membranous urethra. Song et al did autopsy on males found dorsal nerve of the penis (DNP), the terminal branch of the pudendal nerve, innervates the membranous urethra in 53.3% specimens. In addition, urethral mucosa has branches of DNP innervated. Dorsal penile nerve block (DPNB) is usually used for circumcision in children and it has been shown to provide effective analgesia for penile surgeries. According to the evidence that some DNP branches innervate membranous urethra and urethra mucosa and most pain originates from cystoscope passing through membranous urethra, we speculated that DPNB could overall reduce pain level in men during rigid cystoscopy.

Conditions

• Pain

Interventions

Type	Name	Description
PROCEDURE	Dorsal Penile Nerve Block	Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
DRUG	Ropivacaine	0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
DRUG	Tetracaine	1% Tetracaine gel instilled into urethra

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-07-20
• Last updated: 2020-03-31
• Results posted: 2016-07-11

Locations

1 site across 1 country: China