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This study will determine the effectiveness and safety of dorsal penile nerve block (DPNB) in men undergoing rigid cystoscopy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tetracaine gel group | Placebo Comparator | Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy |
|
| Dorsal penile nerve block group | Experimental | Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy |
|
| Combination group | Experimental | Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dorsal Penile Nerve Block | Procedure | Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guizhi Du, Doctor | West China Hospital of Sichuan University, Department of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University, Department of Anesthesiology | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23827737 | Background | Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Comperat E, Sylvester RJ, Kaasinen E, Bohle A, Palou Redorta J, Roupret M; European Association of Urology. EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder: update 2013. Eur Urol. 2013 Oct;64(4):639-53. doi: 10.1016/j.eururo.2013.06.003. Epub 2013 Jun 12. | |
| 10647665 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tetracaine Gel Group | Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra |
| FG001 | Dorsal Penile Nerve Block Group | Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis |
| FG002 | Combination Group | Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tetracaine Gel Group | Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy Tetracaine: 1% Tetracaine gel instilled into urethra |
| BG001 | Dorsal Penile Nerve Block Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | at cystoscopic inspection of external sphincter |
|
from beginning of dorsal penile nerve block to end of cystoscopy
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tetracaine Group | tetracaine gel plus DPNB with saline |
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The VAS scale was the only main observe index, and patients could have different cognition of pain and this may affect the evaluation of pain.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Guizhi Du, Associate professor | West China Hospital, Department of Anesthesiology | +86 18980602213 | du_guizhi@yahoo.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D013748 | Tetracaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine | Drug | 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis |
|
| Tetracaine | Drug | 1% Tetracaine gel instilled into 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 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 |
| Ramsey EW, Elhilali M, Goldenberg SL, Nickel CJ, Norman R, Perreault JP, Piercy B, Trachtenberg J. Practice patterns of Canadian urologists in benign prostatic hyperplasia and prostate cancer. Canadian Prostate Health Council. J Urol. 2000 Feb;163(2):499-502. |
| 8976223 | Background | Goldfischer ER, Cromie WJ, Karrison TG, Naszkiewicz L, Gerber GS. Randomized, prospective, double-blind study of the effects on pain perception of lidocaine jelly versus plain lubricant during outpatient rigid cystoscopy. J Urol. 1997 Jan;157(1):90-4. |
| 25817101 | Background | Seklehner S, Remzi M, Fajkovic H, Saratlija-Novakovic Z, Skopek M, Resch I, Duvnjak M, Hruby S, Librenjak D, Hubner W, Breinl E, Riedl C, Engelhardt PF. Prospective multi-institutional study analyzing pain perception of flexible and rigid cystoscopy in men. Urology. 2015 Apr;85(4):737-41. doi: 10.1016/j.urology.2015.01.007. |
| 16679829 | Background | Taghizadeh AK, El Madani A, Gard PR, Li CY, Thomas PJ, Denyer SP. When does it hurt? Pain during flexible cystoscopy in men. Urol Int. 2006;76(4):301-3. doi: 10.1159/000092051. |
| 19760755 | Background | Song LJ, Lu HK, Wang JP, Xu YM. Cadaveric study of nerves supplying the membranous urethra. Neurourol Urodyn. 2010 Apr;29(4):592-5. doi: 10.1002/nau.20768. |
| 24238564 | Background | Kozacioglu Z, Kiray A, Ergur I, Zeybek G, Degirmenci T, Gunlusoy B. Anatomy of the dorsal nerve of the penis, clinical implications. Urology. 2014 Jan;83(1):121-4. doi: 10.1016/j.urology.2013.07.075. Epub 2013 Nov 12. |
| 660375 | Background | Kirya C, Werthmann MW Jr. Neonatal circumcision and penile dorsal nerve block--a painless procedure. J Pediatr. 1978 Jun;92(6):998-1000. doi: 10.1016/s0022-3476(78)80386-2. |
| 35475300 | Derived | 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. |
| 26988368 | Derived | Qiu Y, Hu AM, Liu J, Du GZ. Dorsal penile nerve block for rigid cystoscopy in men: study protocol for a randomized controlled trial. Trials. 2016 Mar 18;17(1):147. doi: 10.1186/s13063-016-1281-9. |
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
| BG002 | Combination Group | Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Body weight | Mean | Standard Deviation | Kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body mass index | Mean | Standard Deviation | Kg/m^2 |
|
| Duration of cystoscopy | Mean | Standard Deviation | min |
|
| Cystoscopy history | Number | participants |
|
| OG002 | Combination Group | Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis Tetracaine: 1% Tetracaine gel instilled into urethra |
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | before gel administration |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | at cystoscopic inspection of penile and bulbar urethra |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | at cystoscopic inspection of prostate and bladder |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | after withdrawal of cystoscope |
|
|
|
| Secondary | Heart Rate Before Gel Administration | Posted | Mean | Standard Deviation | Beats per minute | before gel administration |
|
|
|
| Secondary | Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra | Posted | Mean | Standard Deviation | Beats per minute | at cystoscopic inspection of penile and bulbar urethra |
|
|
|
| Secondary | Heart Rate at Cystoscopic Inspection of External Sphincter | Posted | Mean | Standard Deviation | Beats per minute | at cystoscopic inspection of external sphincter |
|
|
|
| Secondary | Heart Rate After Withdrawal of Cystoscope | Posted | Mean | Standard Deviation | Beats per minute | after withdrawal of cystoscope |
|
|
|
| Secondary | Mean Arterial Pressure Before Gel Administration | Posted | Mean | Standard Deviation | mmHg | before gel administration |
|
|
|
| Secondary | Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra | Posted | Mean | Standard Deviation | mmHg | at cystoscopic inspection of penile and bulbar urthra |
|
|
|
| Secondary | Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter | Posted | Mean | Standard Deviation | mmHg | at cystoscopic inspection of external sphincter |
|
|
|
| Secondary | Mean Arterial Pressure After Withdrawal of Cystoscope | Posted | Mean | Standard Deviation | mmHg | after withdrawal of cystoscope |
|
|
|
| Secondary | Oxygen Saturation by Pulse Before Gel Administration | Posted | Median | Inter-Quartile Range | percentage | before gel administration |
|
|
|
| Secondary | Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra | Posted | Median | Inter-Quartile Range | percentage | at cystoscopic inspection of penile and bulbar urthra |
|
|
|
| Secondary | Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter | Posted | Median | Inter-Quartile Range | percentage | at cystoscopic inspection of external sphincter |
|
|
|
| Secondary | Oxygen Saturation by Pulse After Withdrawal of Cystoscope | Posted | Median | Inter-Quartile Range | percentage | after withdrawal of cystoscope |
|
|
|
| Secondary | Breath Rate Before Gel Administration | Posted | Mean | Standard Deviation | times per minute | before gel administration |
|
|
|
| Secondary | Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra | Posted | Mean | Standard Deviation | times per minute | at cystoscopic inspection of penile and bulbar Urthra |
|
|
|
| Secondary | Breath Rate at Cystoscopic Inspection of External Sphincter | Posted | Mean | Standard Deviation | times per minute | at cystoscopic inspection of external sphincter |
|
|
|
| Secondary | Breath Rate After Withdrawal of Cystoscope | Posted | Mean | Standard Deviation | times per minute | after withdrawal of cystoscope |
|
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | DPNB Group | DPNB with ropivacaine plus plain lubricant | 0 | 86 | 0 | 86 |
| EG002 | Combination Group | DPNB with ropivacaine plus tetracaine gel | 0 | 86 | 0 | 86 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |