Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

NCT ID: NCT02502487

Last Updated: 2020-03-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-03-31

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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tetracaine gel group

Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy

Group Type PLACEBO_COMPARATOR

Tetracaine

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Dorsal Penile Nerve Block

Intervention Type PROCEDURE

Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis

Ropivacaine

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Dorsal Penile Nerve Block

Intervention Type PROCEDURE

Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis

Ropivacaine

Intervention Type 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

Intervention Type DRUG

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

Intervention Type PROCEDURE

Ropivacaine

0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis

Intervention Type DRUG

Tetracaine

1% Tetracaine gel instilled into urethra

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yan Qiu

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

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.

Reference Type BACKGROUND
PMID: 23827737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10647665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8976223 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25817101 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16679829 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19760755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24238564 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 660375 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35475300 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26988368 (View on PubMed)

Other Identifiers

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WestChinaHAesthesia-1

Identifier Type: -

Identifier Source: org_study_id

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