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PainNCT02502487

Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

A study testing Dorsal Penile Nerve Block, Ropivacaine and Tetracaine in people with Pain, run by West China Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 20 to 75 years, men only
Conditions the study is for
Pain
What is being tested?
Dorsal Penile Nerve Block, Ropivacaine and Tetracaine
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
258 participants
Where
1 siteChina
Study dates
Jun 2015to Mar 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital of Sichuan University, Department of Anesthesiology

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Pain
Being tested
Dorsal Penile Nerve Block, Ropivacaine, Tetracaine
Keywords
Analgesia, Cystoscopy, Dorsal nerve of penis, Nerve block, Ropivacaine
Medical subject headings
Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dorsal Penile Nerve BlockProcedure or surgery

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

  • RopivacaineDrug

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

  • TetracaineDrug

    1% Tetracaine gel instilled into urethra

Study groups in NCT02502487
Study groupRoleWhat they receive
Tetracaine gel groupPlacebo comparatorDorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Receives: Drug: Tetracaine
Dorsal penile nerve block groupExperimentalDorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
Receives: Procedure: Dorsal Penile Nerve Block; Drug: Ropivacaine
Combination groupExperimentalDorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
Receives: Procedure: Dorsal Penile Nerve Block; Drug: Ropivacaine; Drug: Tetracaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at cystoscopic inspection of external sphincter

Secondary outcomes (20)

  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.

    Measured: before gel administration

  2. 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.

    Measured: at cystoscopic inspection of penile and bulbar urethra

  3. 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.

    Measured: at cystoscopic inspection of prostate and bladder

  4. 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.

    Measured: after withdrawal of cystoscope

  5. Heart Rate Before Gel Administration

    Measured: before gel administration

  6. Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra

    Measured: at cystoscopic inspection of penile and bulbar urethra

  7. Heart Rate at Cystoscopic Inspection of External Sphincter

    Measured: at cystoscopic inspection of external sphincter

  8. Heart Rate After Withdrawal of Cystoscope

    Measured: after withdrawal of cystoscope

  9. Mean Arterial Pressure Before Gel Administration

    Measured: before gel administration

  10. Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra

    Measured: at cystoscopic inspection of penile and bulbar urthra

  11. Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter

    Measured: at cystoscopic inspection of external sphincter

  12. Mean Arterial Pressure After Withdrawal of Cystoscope

    Measured: after withdrawal of cystoscope

  13. Oxygen Saturation by Pulse Before Gel Administration

    Measured: before gel administration

  14. Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra

    Measured: at cystoscopic inspection of penile and bulbar urthra

  15. Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter

    Measured: at cystoscopic inspection of external sphincter

  16. Oxygen Saturation by Pulse After Withdrawal of Cystoscope

    Measured: after withdrawal of cystoscope

  17. Breath Rate Before Gel Administration

    Measured: before gel administration

  18. Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra

    Measured: at cystoscopic inspection of penile and bulbar Urthra

  19. Breath Rate at Cystoscopic Inspection of External Sphincter

    Measured: at cystoscopic inspection of external sphincter

  20. Breath Rate After Withdrawal of Cystoscope

    Measured: after withdrawal of cystoscope

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
258 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02502487
Sponsor's protocol ID
WestChinaHAesthesia-1
Status last verified
Mar 2020
First submitted
6 Jul 2015
Last updated
31 Mar 2020
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 23827737

  • 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.

    PubMed 10647665

  • 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.

    PubMed 8976223

  • 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.

    PubMed 25817101

  • 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.

    PubMed 16679829

  • 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.

    PubMed 19760755

  • 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.

    PubMed 24238564

  • 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.

    PubMed 660375

  • 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.

    PubMed 35475300

  • 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.

    PubMed 26988368

Questions about this trial

What is this clinical trial studying?

A study testing Dorsal Penile Nerve Block, Ropivacaine and Tetracaine in people with Pain, run by West China Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) for Pain (time frame: at cystoscopic inspection of external sphincter). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02502487, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.

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Dorsal Penile Nerve Block for Rigid Cystoscopy in Men | AzTrials