N/A
N=258
Dorsal Penile Nerve Block for Rigid Cystoscopy in Men
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02502487 ↗Enrolled (actual)
258
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Visual Analog Scale (VAS) for Pain — 6; 4; 4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dorsal Penile Nerve Block (Procedure); Ropivacaine (Drug); Tetracaine (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Male
- Sponsor
- West China Hospital
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale (VAS) for Pain |
0; 0; 0 | — |
| SECONDARY Visual Analog Scale (VAS) for Pain |
0; 0; 0 | — |
| SECONDARY Visual Analog Scale (VAS) for Pain |
0; 0; 0 | — |
| SECONDARY Visual Analog Scale (VAS) for Pain |
0; 0; 0 | — |
| SECONDARY Visual Analog Scale (VAS) for Pain |
0; 0; 0 | — |
| SECONDARY Heart Rate Before Gel Administration |
75.0; 75.9; 73.6 | — |
| SECONDARY Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra |
84.8; 83.8; 81.1 | — |
| SECONDARY Heart Rate at Cystoscopic Inspection of External Sphincter |
96.7; 90.2; 86.2 | — |
| SECONDARY Heart Rate After Withdrawal of Cystoscope |
76.7; 72.3; 71.6 | — |
| SECONDARY Mean Arterial Pressure Before Gel Administration |
95.3; 96.6; 95.1 | — |
| SECONDARY Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra |
100; 99.8; 98.2 | — |
| SECONDARY Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter |
113.7; 105.8; 104.8 | — |
| SECONDARY Mean Arterial Pressure After Withdrawal of Cystoscope |
99.3; 95.7; 95.2 | — |
| SECONDARY Oxygen Saturation by Pulse Before Gel Administration |
99; 98; 99 | — |
| SECONDARY Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra |
99; 98; 99 | — |
| SECONDARY Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter |
99; 98; 99 | — |
| SECONDARY Oxygen Saturation by Pulse After Withdrawal of Cystoscope |
99; 98; 99 | — |
| SECONDARY Breath Rate Before Gel Administration |
19.8; 19.6; 19.5 | — |
| SECONDARY Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra |
20.0; 19.8; 19.6 | — |
| SECONDARY Breath Rate at Cystoscopic Inspection of External Sphincter |
20.1; 19.8; 19.8 | — |
| SECONDARY Breath Rate After Withdrawal of Cystoscope |
19.7; 19.4; 19.4 | — |
Summary
This study will determine the effectiveness and safety of dorsal penile nerve block (DPNB) in men undergoing rigid cystoscopy.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02502487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.