Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

NCT02502487 | Completed Results

• 1 other identifier: WestChinaHAesthesia-1
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

Analgesia; Cystoscopy; Dorsal nerve of penis; Nerve block; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Visual Analog Scale (VAS) for Pain

  before gel administration

• Visual Analog Scale (VAS) for Pain

  at cystoscopic inspection of penile and bulbar urethra

• Visual Analog Scale (VAS) for Pain

  at cystoscopic inspection of prostate and bladder

• Visual Analog Scale (VAS) for Pain

  after withdrawal of cystoscope

• Heart Rate Before Gel Administration

  before gel administration

Study Arms (3)

Tetracaine gel group

PLACEBO COMPARATOR

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

Drug: Tetracaine

Dorsal penile nerve block group

EXPERIMENTAL

Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy

Procedure: Dorsal Penile Nerve Block; Drug: Ropivacaine

Combination group

EXPERIMENTAL

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

Procedure: Dorsal Penile Nerve Block; Drug: Ropivacaine; Drug: Tetracaine

Interventions

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

Combination group; Dorsal penile nerve block group

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

Combination group; Dorsal penile nerve block group

Tetracaine DRUG

1% Tetracaine gel instilled into urethra

Combination group; Tetracaine gel group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) Physical Status I-II
• Without history of urethral or prostatic surgery
• Without respiration or circulation disorders
• Without chronic pain

You may not qualify if:

• Allergy to local anesthetics
• Coagulation disorder or usage of antiplatelet drugs
• Infection at the site of puncture point
• Severe urethral stenosis

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University, Department of Anesthesiology

Chengdu, Sichuan, 610041, China

Location

Related Publications (10)

• 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.

  PMID: 23827737 BACKGROUND

• 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.

  PMID: 10647665 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.

  PMID: 8976223 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.

  PMID: 25817101 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.

  PMID: 16679829 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.

  PMID: 19760755 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.

  PMID: 24238564 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.

  PMID: 660375 BACKGROUND

• 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.

  PMID: 35475300 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.

  PMID: 26988368 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Ropivacaine; Tetracaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Guizhi Du, Associate professor
• Organization: West China Hospital, Department of Anesthesiology

du_guizhi@yahoo.com

+86 18980602213

Study Officials

• Guizhi Du, Doctor

  West China Hospital of Sichuan University, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 20, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 31, 2020
• Results First Posted: July 11, 2016

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)