Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Tetracaine; Procedure: Dorsal Penile Nerve Block; Drug: Ropivacaine

• Registration Number: NCT02502487
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-20
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2016-04-14
• Results First Submitted QC: 2016-05-26
• Results First Posted: 2016-07-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 258

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Tetracaine gel group	Tetracaine	Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Dorsal penile nerve block group	Dorsal Penile Nerve Block	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Combination group	Dorsal Penile Nerve Block	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Dorsal penile nerve block group	Ropivacaine	Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Combination group	Tetracaine	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Combination group	Ropivacaine	Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) for Pain	at cystoscopic inspection of external sphincter	A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) for Pain	after withdrawal of cystoscope	A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.
Heart Rate Before Gel Administration	before gel administration
Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra	at cystoscopic inspection of penile and bulbar urethra
Heart Rate at Cystoscopic Inspection of External Sphincter	at cystoscopic inspection of external sphincter
Heart Rate After Withdrawal of Cystoscope	after withdrawal of cystoscope
Mean Arterial Pressure Before Gel Administration	before gel administration
Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra	at cystoscopic inspection of penile and bulbar urthra
Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter	at cystoscopic inspection of external sphincter
Mean Arterial Pressure After Withdrawal of Cystoscope	after withdrawal of cystoscope
Oxygen Saturation by Pulse Before Gel Administration	before gel administration
Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter	at cystoscopic inspection of external sphincter
Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra	at cystoscopic inspection of penile and bulbar urthra
Oxygen Saturation by Pulse After Withdrawal of Cystoscope	after withdrawal of cystoscope
Breath Rate Before Gel Administration	before gel administration
Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra	at cystoscopic inspection of penile and bulbar Urthra
Breath Rate at Cystoscopic Inspection of External Sphincter	at cystoscopic inspection of external sphincter
Breath Rate After Withdrawal of Cystoscope	after withdrawal of cystoscope

Trial Locations

Locations (1)

West China Hospital of Sichuan University, Department of Anesthesiology; 🇨🇳 Chengdu, Sichuan, China