Trial Outcomes & Findings for Dorsal Penile Nerve Block for Rigid Cystoscopy in Men (NCT NCT02502487)
NCT ID: NCT02502487
Last Updated: 2020-03-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
258 participants
Primary outcome timeframe
at cystoscopic inspection of external sphincter
Results posted on
2020-03-31
Participant Flow
Participant milestones
| Measure |
Tetracaine Gel Group
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
86
|
86
|
86
|
|
Overall Study
COMPLETED
|
86
|
86
|
86
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dorsal Penile Nerve Block for Rigid Cystoscopy in Men
Baseline characteristics by cohort
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
Total
n=258 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
52.1 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
|
Sex/Gender, Customized
Male
|
86 participants
n=5 Participants
|
86 participants
n=7 Participants
|
86 participants
n=5 Participants
|
258 participants
n=4 Participants
|
|
Body weight
|
66.8 Kg
STANDARD_DEVIATION 8.2 • n=5 Participants
|
68.8 Kg
STANDARD_DEVIATION 9.6 • n=7 Participants
|
66.4 Kg
STANDARD_DEVIATION 8.9 • n=5 Participants
|
67.3 Kg
STANDARD_DEVIATION 8.9 • n=4 Participants
|
|
Height
|
167.3 cm
STANDARD_DEVIATION 5.6 • n=5 Participants
|
168.7 cm
STANDARD_DEVIATION 5.5 • n=7 Participants
|
167.8 cm
STANDARD_DEVIATION 6.4 • n=5 Participants
|
167.9 cm
STANDARD_DEVIATION 5.8 • n=4 Participants
|
|
Body mass index
|
23.8 Kg/m^2
STANDARD_DEVIATION 2.4 • n=5 Participants
|
24.2 Kg/m^2
STANDARD_DEVIATION 3.0 • n=7 Participants
|
23.6 Kg/m^2
STANDARD_DEVIATION 2.7 • n=5 Participants
|
23.8 Kg/m^2
STANDARD_DEVIATION 2.7 • n=4 Participants
|
|
Duration of cystoscopy
|
3.5 min
STANDARD_DEVIATION 0.6 • n=5 Participants
|
3.5 min
STANDARD_DEVIATION 0.5 • n=7 Participants
|
3.4 min
STANDARD_DEVIATION 0.5 • n=5 Participants
|
3.5 min
STANDARD_DEVIATION 0.6 • n=4 Participants
|
|
Cystoscopy history
First-time cystoscopy
|
60 participants
n=5 Participants
|
58 participants
n=7 Participants
|
61 participants
n=5 Participants
|
179 participants
n=4 Participants
|
|
Cystoscopy history
Repeat cystoscopy
|
26 participants
n=5 Participants
|
28 participants
n=7 Participants
|
25 participants
n=5 Participants
|
79 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: at cystoscopic inspection of external sphincterA 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.
Outcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Visual Analog Scale (VAS) for Pain
|
6 units on a scale
Interval 5.0 to 7.0
|
4 units on a scale
Interval 3.0 to 6.0
|
4 units on a scale
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: before gel administrationA 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.
Outcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Visual Analog Scale (VAS) for Pain
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: at cystoscopic inspection of penile and bulbar urethraA 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.
Outcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Visual Analog Scale (VAS) for Pain
|
1 units on a scale
Interval 1.0 to 2.0
|
1 units on a scale
Interval 1.0 to 2.0
|
1 units on a scale
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: at cystoscopic inspection of prostate and bladderA 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.
Outcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Visual Analog Scale (VAS) for Pain
|
2 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: after withdrawal of cystoscopeA 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.
Outcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Visual Analog Scale (VAS) for Pain
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: before gel administrationOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Heart Rate Before Gel Administration
|
75.0 Beats per minute
Standard Deviation 9.7
|
75.9 Beats per minute
Standard Deviation 9.4
|
73.6 Beats per minute
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: at cystoscopic inspection of penile and bulbar urethraOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra
|
84.8 Beats per minute
Standard Deviation 11.7
|
83.8 Beats per minute
Standard Deviation 12.0
|
81.1 Beats per minute
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: at cystoscopic inspection of external sphincterOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Heart Rate at Cystoscopic Inspection of External Sphincter
|
96.7 Beats per minute
Standard Deviation 14.1
|
90.2 Beats per minute
Standard Deviation 14.9
|
86.2 Beats per minute
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: after withdrawal of cystoscopeOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Heart Rate After Withdrawal of Cystoscope
|
76.7 Beats per minute
Standard Deviation 10.9
|
72.3 Beats per minute
Standard Deviation 10.0
|
71.6 Beats per minute
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: before gel administrationOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Mean Arterial Pressure Before Gel Administration
|
95.3 mmHg
Standard Deviation 10.2
|
96.6 mmHg
Standard Deviation 9.7
|
95.1 mmHg
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: at cystoscopic inspection of penile and bulbar urthraOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra
|
100 mmHg
Standard Deviation 10.6
|
99.8 mmHg
Standard Deviation 10.1
|
98.2 mmHg
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: at cystoscopic inspection of external sphincterOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter
|
113.7 mmHg
Standard Deviation 11.7
|
105.8 mmHg
Standard Deviation 10.5
|
104.8 mmHg
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: after withdrawal of cystoscopeOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Mean Arterial Pressure After Withdrawal of Cystoscope
|
99.3 mmHg
Standard Deviation 9.8
|
95.7 mmHg
Standard Deviation 8.4
|
95.2 mmHg
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: before gel administrationOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Oxygen Saturation by Pulse Before Gel Administration
|
99 percentage
Interval 98.0 to 99.0
|
98 percentage
Interval 97.0 to 99.0
|
99 percentage
Interval 98.0 to 99.0
|
SECONDARY outcome
Timeframe: at cystoscopic inspection of penile and bulbar urthraOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra
|
99 percentage
Interval 98.0 to 99.0
|
98 percentage
Interval 98.0 to 99.0
|
99 percentage
Interval 98.0 to 99.0
|
SECONDARY outcome
Timeframe: at cystoscopic inspection of external sphincterOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter
|
99 percentage
Interval 98.0 to 99.0
|
98 percentage
Interval 97.0 to 99.0
|
99 percentage
Interval 98.0 to 99.0
|
SECONDARY outcome
Timeframe: after withdrawal of cystoscopeOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Oxygen Saturation by Pulse After Withdrawal of Cystoscope
|
99 percentage
Interval 98.0 to 99.0
|
98 percentage
Interval 98.0 to 99.0
|
99 percentage
Interval 98.0 to 99.0
|
SECONDARY outcome
Timeframe: before gel administrationOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Breath Rate Before Gel Administration
|
19.8 times per minute
Standard Deviation 1.1
|
19.6 times per minute
Standard Deviation 1.6
|
19.5 times per minute
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: at cystoscopic inspection of penile and bulbar UrthraOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra
|
20.0 times per minute
Standard Deviation 1.2
|
19.8 times per minute
Standard Deviation 1.5
|
19.6 times per minute
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: at cystoscopic inspection of external sphincterOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Breath Rate at Cystoscopic Inspection of External Sphincter
|
20.1 times per minute
Standard Deviation 1.3
|
19.8 times per minute
Standard Deviation 1.7
|
19.8 times per minute
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: after withdrawal of cystoscopeOutcome measures
| Measure |
Tetracaine Gel Group
n=86 Participants
Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra
|
Dorsal Penile Nerve Block Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy
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
Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
|
Combination Group
n=86 Participants
Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy
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
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
|
|---|---|---|---|
|
Breath Rate After Withdrawal of Cystoscope
|
19.7 times per minute
Standard Deviation 1.2
|
19.4 times per minute
Standard Deviation 1.5
|
19.4 times per minute
Standard Deviation 1.2
|
Adverse Events
Tetracaine Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DPNB Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combination Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Guizhi Du, Associate professor
West China Hospital, Department of Anesthesiology
Phone: +86 18980602213
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place