Clinical trial NCT02502487: Dorsal Penile Nerve Block for Rigid Cystoscopy in Men
Official title: Dorsal Penile Nerve Block for Rigid Cystoscopy in Men: a Single-center, Randomized, Double-blind and Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Analgesia
Cystoscopy
Dorsal nerve of penis
Nerve block
Ropivacaine
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 258
Sex: MALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS) for Pain
timeFrame: at cystoscopic inspection of external sphincter
Secondary outcomes:
measure: Visual Analog Scale (VAS) for Pain
timeFrame: before gel administration
measure: Visual Analog Scale (VAS) for Pain
timeFrame: at cystoscopic inspection of penile and bulbar urethra
measure: Visual Analog Scale (VAS) for Pain
timeFrame: at cystoscopic inspection of prostate and bladder
measure: Visual Analog Scale (VAS) for Pain
timeFrame: after withdrawal of cystoscope
measure: Heart Rate Before Gel Administration
timeFrame: before gel administration
measure: Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra
timeFrame: at cystoscopic inspection of penile and bulbar urethra
measure: Heart Rate at Cystoscopic Inspection of External Sphincter
timeFrame: at cystoscopic inspection of external sphincter
measure: Heart Rate After Withdrawal of Cystoscope
timeFrame: after withdrawal of cystoscope
measure: Mean Arterial Pressure Before Gel Administration
timeFrame: before gel administration
measure: Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra
timeFrame: at cystoscopic inspection of penile and bulbar urthra
measure: Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter
timeFrame: at cystoscopic inspection of external sphincter
measure: Mean Arterial Pressure After Withdrawal of Cystoscope
timeFrame: after withdrawal of cystoscope
measure: Oxygen Saturation by Pulse Before Gel Administration
timeFrame: before gel administration
measure: Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra
timeFrame: at cystoscopic inspection of penile and bulbar urthra
measure: Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter
timeFrame: at cystoscopic inspection of external sphincter
measure: Oxygen Saturation by Pulse After Withdrawal of Cystoscope
timeFrame: after withdrawal of cystoscope
measure: Breath Rate Before Gel Administration
timeFrame: before gel administration
measure: Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra
timeFrame: at cystoscopic inspection of penile and bulbar Urthra
measure: Breath Rate at Cystoscopic Inspection of External Sphincter
timeFrame: at cystoscopic inspection of external sphincter
measure: Breath Rate After Withdrawal of Cystoscope
timeFrame: after withdrawal of cystoscope
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University, Department of Anesthesiology
state: Sichuan
Study officials:
affiliation: West China Hospital of Sichuan University, Department of Anesthesiology
name: Guizhi Du, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Qiu Y, Liu X, Wei W, Du G. Dorsal penile nerve block alleviates pain in men undergoing rigid cystoscopy: A single-center, randomized, double-blind, and placebo-controlled trial. BJUI Compass. 2021 Feb 5;2(4):260-266. doi: 10.1002/bco2.76. eCollection 2021 Jul.
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