Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

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

Detailed Description
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Procedure: Dorsal Penile Nerve Block
* Drug: Ropivacaine
* Drug: Tetracaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Tetracaine gel group<br>Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy | Drug: Tetracaine<br>* 1% Tetracaine gel instilled into urethra<br>|
| Experimental: Dorsal penile nerve block group<br>Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy | Procedure: Dorsal Penile Nerve Block<br>* Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis<br>Drug: Ropivacaine<br>* 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis<br>|
| Experimental: Combination group<br>Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy | Procedure: Dorsal Penile Nerve Block<br>* Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis<br>Drug: Ropivacaine<br>* 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis<br>Drug: Tetracaine<br>* 1% Tetracaine gel instilled into urethra<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) for Pain | 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. | at cystoscopic inspection of external sphincter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) for Pain | 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. | before gel administration | 
| Visual Analog Scale (VAS) for Pain | 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. | at cystoscopic inspection of penile and bulbar urethra | 
| Visual Analog Scale (VAS) for Pain | 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. | at cystoscopic inspection of prostate and bladder | 
| Visual Analog Scale (VAS) for Pain | 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. | after withdrawal of cystoscope | 
| 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 Penile and Bulbar Urthra |  | at cystoscopic inspection of penile and bulbar urthra | 
| Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter |  | at cystoscopic inspection of external sphincter | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Cystoscopy, Dorsal nerve of penis, Nerve block, Ropivacaine