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Dorsal Penile Nerve Block for Rigid Cystoscopy in Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02502487
Recruitment Status : Completed
First Posted : July 20, 2015
Results First Posted : July 11, 2016
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Yan Qiu, West China Hospital

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

Condition or disease Intervention/treatment Phase
Pain Procedure: Dorsal Penile Nerve Block Drug: Ropivacaine Drug: Tetracaine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dorsal Penile Nerve Block for Rigid Cystoscopy in Men: a Single-center, Randomized, Double-blind and Placebo-controlled Study
Study Start Date : June 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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
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

Drug: Tetracaine
1% Tetracaine gel instilled into urethra




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502487


Locations
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China, Sichuan
West China Hospital of Sichuan University, Department of Anesthesiology
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Guizhi Du, Doctor West China Hospital of Sichuan University, Department of Anesthesiology
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yan Qiu, Attending Physician, West China Hospital
ClinicalTrials.gov Identifier: NCT02502487    
Other Study ID Numbers: WestChinaHAesthesia-1
First Posted: July 20, 2015    Key Record Dates
Results First Posted: July 11, 2016
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yan Qiu, West China Hospital:
Analgesia
Cystoscopy
Dorsal nerve of penis
Nerve block
Ropivacaine
Additional relevant MeSH terms:
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Ropivacaine
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents