Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

Dorsal Penile Nerve Block for Rigid Cystoscopy in Men: a Single-center, Randomized, Double-blind and Placebo-controlled Study

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Tetracaine; Procedure: Dorsal Penile Nerve Block; Drug: Ropivacaine

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 Type: Interventional
• Enrollment (Actual): 258
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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	Drug: Tetracaine; 1% Tetracaine gel instilled into urethra; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: July 6, 2015
• First Submitted That Met QC Criteria: July 15, 2015
• First Posted (Estimate): July 20, 2015

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Analgesia; Cystoscopy; Ropivacaine; Nerve block; Dorsal nerve of penis
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine; Tetracaine
• Other Study ID Numbers: WestChinaHAesthesia-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No