Conditions: Pain
Keywords: Analgesia Cystoscopy Dorsal nerve of penis Nerve block Ropivacaine
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 258
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy arm 2: Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy arm 3: Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy

Interventions: intervention 1: Dorsal Penile Nerve Block intervention 2: Ropivacaine intervention 3: Tetracaine
Intervention descriptions: intervention 1: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis intervention 2: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis intervention 3: 1% Tetracaine gel instilled into urethra

Protocol document: