Study Results
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View full resultsBasic Information
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COMPLETED
NA
258 participants
INTERVENTIONAL
2015-06-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
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Tetracaine gel group
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine
1% Tetracaine gel instilled into urethra
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Without history of urethral or prostatic surgery
* Without respiration or circulation disorders
* Without chronic pain
Exclusion Criteria
* Coagulation disorder or usage of antiplatelet drugs
* Infection at the site of puncture point
* Severe urethral stenosis
20 Years
75 Years
MALE
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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Yan Qiu
Attending Physician
Principal Investigators
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Guizhi Du, Doctor
Role: PRINCIPAL_INVESTIGATOR
West China Hospital of Sichuan University, Department of Anesthesiology
Locations
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West China Hospital of Sichuan University, Department of Anesthesiology
Chengdu, Sichuan, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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WestChinaHAesthesia-1
Identifier Type: -
Identifier Source: org_study_id
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