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Completed

NCT Number: NCT02502487

Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

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

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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital of Sichuan University, Department of Anesthesiology

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Tetracaine

Drug

1% Tetracaine gel instilled into urethra

Primary outcomes

  1. Visual Analog Scale (VAS) for Pain

    Time frame: at cystoscopic inspection of external sphincter

    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.

Secondary outcomes

  1. Visual Analog Scale (VAS) for Pain

    Time frame: before gel administration

    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.

  2. Visual Analog Scale (VAS) for Pain

    Time frame: at cystoscopic inspection of penile and bulbar urethra

    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.

  3. Visual Analog Scale (VAS) for Pain

    Time frame: at cystoscopic inspection of prostate and bladder

    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.

  4. Visual Analog Scale (VAS) for Pain

    Time frame: after withdrawal of cystoscope

    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.

  5. Heart Rate Before Gel Administration

    Time frame: before gel administration

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

    Time frame: at cystoscopic inspection of penile and bulbar urethra

  7. Heart Rate at Cystoscopic Inspection of External Sphincter

    Time frame: at cystoscopic inspection of external sphincter

  8. Heart Rate After Withdrawal of Cystoscope

    Time frame: after withdrawal of cystoscope

  9. Mean Arterial Pressure Before Gel Administration

    Time frame: before gel administration

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

    Time frame: at cystoscopic inspection of penile and bulbar urthra

  11. Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter

    Time frame: at cystoscopic inspection of external sphincter

  12. Mean Arterial Pressure After Withdrawal of Cystoscope

    Time frame: after withdrawal of cystoscope

  13. Oxygen Saturation by Pulse Before Gel Administration

    Time frame: before gel administration

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

    Time frame: at cystoscopic inspection of penile and bulbar urthra

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

    Time frame: at cystoscopic inspection of external sphincter

  16. Oxygen Saturation by Pulse After Withdrawal of Cystoscope

    Time frame: after withdrawal of cystoscope

  17. Breath Rate Before Gel Administration

    Time frame: before gel administration

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

    Time frame: at cystoscopic inspection of penile and bulbar Urthra

  19. Breath Rate at Cystoscopic Inspection of External Sphincter

    Time frame: at cystoscopic inspection of external sphincter

  20. Breath Rate After Withdrawal of Cystoscope

    Time frame: after withdrawal of cystoscope

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 20, 2015
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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