Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502487
• Other study ID #: WestChinaHAesthesia-1
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2020
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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
• Tetracaine
1% Tetracaine gel instilled into urethra

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University, Department of Anesthesiology	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. — View Citation

Kirya C, Werthmann MW Jr. Neonatal circumcision and penile dorsal nerve block--a painless procedure. J Pediatr. 1978 Jun;92(6):998-1000. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Heart Rate Before Gel Administration		before gel administration
Secondary	Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra		at cystoscopic inspection of penile and bulbar urethra
Secondary	Heart Rate at Cystoscopic Inspection of External Sphincter		at cystoscopic inspection of external sphincter
Secondary	Heart Rate After Withdrawal of Cystoscope		after withdrawal of cystoscope
Secondary	Mean Arterial Pressure Before Gel Administration		before gel administration
Secondary	Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra		at cystoscopic inspection of penile and bulbar urthra
Secondary	Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter		at cystoscopic inspection of external sphincter
Secondary	Mean Arterial Pressure After Withdrawal of Cystoscope		after withdrawal of cystoscope
Secondary	Oxygen Saturation by Pulse Before Gel Administration		before gel administration
Secondary	Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra		at cystoscopic inspection of penile and bulbar urthra
Secondary	Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter		at cystoscopic inspection of external sphincter
Secondary	Oxygen Saturation by Pulse After Withdrawal of Cystoscope		after withdrawal of cystoscope
Secondary	Breath Rate Before Gel Administration		before gel administration
Secondary	Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra		at cystoscopic inspection of penile and bulbar Urthra
Secondary	Breath Rate at Cystoscopic Inspection of External Sphincter		at cystoscopic inspection of external sphincter
Secondary	Breath Rate After Withdrawal of Cystoscope		after withdrawal of cystoscope