Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

Sichuan University

Status: Completed

Conditions: Pain

Treatments: Drug: Ropivacaine; Procedure: Dorsal Penile Nerve Block; Drug: Tetracaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02502487

WestChinaHAesthesia-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 258 patients

Sex: Male

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) Physical Status I-II
• Without history of urethral or prostatic surgery
• Without respiration or circulation disorders
• Without chronic pain

Exclusion criteria

• Allergy to local anesthetics
• Coagulation disorder or usage of antiplatelet drugs
• Infection at the site of puncture point
• Severe urethral stenosis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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258 participants in 3 patient groups, including a placebo group

Tetracaine gel group

Placebo Comparator group

Description:

Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy

Treatment:

Drug: Tetracaine

Dorsal penile nerve block group

Experimental group

Description:

Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy

Treatment:

Drug: Ropivacaine

Procedure: Dorsal Penile Nerve Block

Combination group

Experimental group

Description:

Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy

Treatment:

Drug: Tetracaine

Drug: Ropivacaine

Procedure: Dorsal Penile Nerve Block