Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

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ClinicalTrials.gov Identifier: NCT02502487

Recruitment Status : Completed

First Posted : July 20, 2015

Results First Posted : July 11, 2016

Last Update Posted : March 31, 2020

Sponsor:

Information provided by (Responsible Party):

Yan Qiu, West China Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pain	Procedure: Dorsal Penile Nerve Block Drug: Ropivacaine Drug: Tetracaine	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	258 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Dorsal Penile Nerve Block for Rigid Cystoscopy in Men: a Single-center, Randomized, Double-blind and Placebo-controlled Study
Study Start Date :	June 2015
Actual Primary Completion Date :	March 2016
Actual Study Completion Date :	March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Tetracaine Tetracaine hydrochloride

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Visual Analog Scale (VAS) for Pain [ Time Frame: 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 :

Visual Analog Scale (VAS) for Pain [ Time Frame: before gel administration ]
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.
Visual Analog Scale (VAS) for Pain [ Time Frame: at cystoscopic inspection of penile and bulbar urethra ]
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.
Visual Analog Scale (VAS) for Pain [ Time Frame: at cystoscopic inspection of prostate and bladder ]
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.
Visual Analog Scale (VAS) for Pain [ Time Frame: 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 [ Time Frame: before gel administration ]
Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra [ Time Frame: at cystoscopic inspection of penile and bulbar urethra ]
Heart Rate at Cystoscopic Inspection of External Sphincter [ Time Frame: at cystoscopic inspection of external sphincter ]
Heart Rate After Withdrawal of Cystoscope [ Time Frame: after withdrawal of cystoscope ]
Mean Arterial Pressure Before Gel Administration [ Time Frame: before gel administration ]
Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra [ Time Frame: at cystoscopic inspection of penile and bulbar urthra ]
Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter [ Time Frame: at cystoscopic inspection of external sphincter ]
Mean Arterial Pressure After Withdrawal of Cystoscope [ Time Frame: after withdrawal of cystoscope ]
Oxygen Saturation by Pulse Before Gel Administration [ Time Frame: before gel administration ]
Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra [ Time Frame: at cystoscopic inspection of penile and bulbar urthra ]
Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter [ Time Frame: at cystoscopic inspection of external sphincter ]
Oxygen Saturation by Pulse After Withdrawal of Cystoscope [ Time Frame: after withdrawal of cystoscope ]
Breath Rate Before Gel Administration [ Time Frame: before gel administration ]
Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra [ Time Frame: at cystoscopic inspection of penile and bulbar Urthra ]
Breath Rate at Cystoscopic Inspection of External Sphincter [ Time Frame: at cystoscopic inspection of external sphincter ]
Breath Rate After Withdrawal of Cystoscope [ Time Frame: after withdrawal of cystoscope ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502487

Locations

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China, Sichuan
West China Hospital of Sichuan University, Department of Anesthesiology
Chengdu, Sichuan, China, 610041

Sponsors and Collaborators

West China Hospital

Investigators

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Principal Investigator:	Guizhi Du, Doctor	West China Hospital of Sichuan University, Department of Anesthesiology

More Information

Publications:

Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, Sylvester RJ, Kaasinen E, Böhle A, Palou Redorta J, Rouprêt 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. Review.

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, Hübner 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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Yan Qiu, Attending Physician, West China Hospital
ClinicalTrials.gov Identifier:	NCT02502487
Other Study ID Numbers:	WestChinaHAesthesia-1
First Posted:	July 20, 2015 Key Record Dates
Results First Posted:	July 11, 2016
Last Update Posted:	March 31, 2020
Last Verified:	March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Yan Qiu, West China Hospital:


Analgesia Cystoscopy Dorsal nerve of penis Nerve block Ropivacaine

Additional relevant MeSH terms:

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Ropivacaine Tetracaine Anesthetics, Local Anesthetics	Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents

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