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Trial record 27 of 495 for:    penis

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 : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
Yan Qiu, West China Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Pain
Interventions Procedure: Dorsal Penile Nerve Block
Drug: Ropivacaine
Drug: Tetracaine
Enrollment 258
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description

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 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

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

Period Title: Overall Study
Started 86 86 86
Completed 86 86 86
Not Completed 0 0 0
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group Total
Hide Arm/Group Description

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 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

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 of all reporting groups
Overall Number of Baseline Participants 86 86 86 258
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 86 participants 86 participants 258 participants
53.4  (11.5) 52.1  (13.0) 53.5  (12.0) 53.0  (12.2)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Male Number Analyzed 86 participants 86 participants 86 participants 258 participants
86 86 86 258
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 86 participants 86 participants 86 participants 258 participants
66.8  (8.2) 68.8  (9.6) 66.4  (8.9) 67.3  (8.9)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 86 participants 86 participants 86 participants 258 participants
167.3  (5.6) 168.7  (5.5) 167.8  (6.4) 167.9  (5.8)
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 86 participants 86 participants 86 participants 258 participants
23.8  (2.4) 24.2  (3.0) 23.6  (2.7) 23.8  (2.7)
Duration of cystoscopy  
Mean (Standard Deviation)
Unit of measure:  Min
Number Analyzed 86 participants 86 participants 86 participants 258 participants
3.5  (0.6) 3.5  (0.5) 3.4  (0.5) 3.5  (0.6)
Cystoscopy history  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 86 participants 258 participants
First-time cystoscopy 60 58 61 179
Repeat cystoscopy 26 28 25 79
1.Primary Outcome
Title Visual Analog Scale (VAS) for Pain
Hide Description 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.
Time Frame at cystoscopic inspection of external sphincter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
6
(5 to 7)
4
(3 to 6)
4
(3 to 5)
2.Secondary Outcome
Title Visual Analog Scale (VAS) for Pain
Hide Description 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.
Time Frame before gel administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
3.Secondary Outcome
Title Visual Analog Scale (VAS) for Pain
Hide Description 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.
Time Frame at cystoscopic inspection of penile and bulbar urethra
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
1
(1 to 2)
1
(1 to 2)
1
(1 to 1)
4.Secondary Outcome
Title Visual Analog Scale (VAS) for Pain
Hide Description 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.
Time Frame at cystoscopic inspection of prostate and bladder
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
2
(0 to 2)
0
(0 to 2)
0
(0 to 1)
5.Secondary Outcome
Title Visual Analog Scale (VAS) for Pain
Hide Description 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.
Time Frame after withdrawal of cystoscope
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
6.Secondary Outcome
Title Heart Rate Before Gel Administration
Hide Description [Not Specified]
Time Frame before gel administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Mean (Standard Deviation)
Unit of Measure: Beats per minute
75.0  (9.7) 75.9  (9.4) 73.6  (10.2)
7.Secondary Outcome
Title Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra
Hide Description [Not Specified]
Time Frame at cystoscopic inspection of penile and bulbar urethra
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Mean (Standard Deviation)
Unit of Measure: Beats per minute
84.8  (11.7) 83.8  (12.0) 81.1  (10.4)
8.Secondary Outcome
Title Heart Rate at Cystoscopic Inspection of External Sphincter
Hide Description [Not Specified]
Time Frame at cystoscopic inspection of external sphincter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Mean (Standard Deviation)
Unit of Measure: Beats per minute
96.7  (14.1) 90.2  (14.9) 86.2  (10.9)
9.Secondary Outcome
Title Heart Rate After Withdrawal of Cystoscope
Hide Description [Not Specified]
Time Frame after withdrawal of cystoscope
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Mean (Standard Deviation)
Unit of Measure: Beats per minute
76.7  (10.9) 72.3  (10.0) 71.6  (9.2)
10.Secondary Outcome
Title Mean Arterial Pressure Before Gel Administration
Hide Description [Not Specified]
Time Frame before gel administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Mean (Standard Deviation)
Unit of Measure: mmHg
95.3  (10.2) 96.6  (9.7) 95.1  (9.9)
11.Secondary Outcome
Title Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra
Hide Description [Not Specified]
Time Frame at cystoscopic inspection of penile and bulbar urthra
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Mean (Standard Deviation)
Unit of Measure: mmHg
100  (10.6) 99.8  (10.1) 98.2  (9.0)
12.Secondary Outcome
Title Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter
Hide Description [Not Specified]
Time Frame at cystoscopic inspection of external sphincter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Mean (Standard Deviation)
Unit of Measure: mmHg
113.7  (11.7) 105.8  (10.5) 104.8  (9.2)
13.Secondary Outcome
Title Mean Arterial Pressure After Withdrawal of Cystoscope
Hide Description [Not Specified]
Time Frame after withdrawal of cystoscope
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Mean (Standard Deviation)
Unit of Measure: mmHg
99.3  (9.8) 95.7  (8.4) 95.2  (8.6)
14.Secondary Outcome
Title Oxygen Saturation by Pulse Before Gel Administration
Hide Description [Not Specified]
Time Frame before gel administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Median (Inter-Quartile Range)
Unit of Measure: percentage
99
(98 to 99)
98
(97 to 99)
99
(98 to 99)
15.Secondary Outcome
Title Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra
Hide Description [Not Specified]
Time Frame at cystoscopic inspection of penile and bulbar urthra
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Median (Inter-Quartile Range)
Unit of Measure: percentage
99
(98 to 99)
98
(98 to 99)
99
(98 to 99)
16.Secondary Outcome
Title Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter
Hide Description [Not Specified]
Time Frame at cystoscopic inspection of external sphincter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Median (Inter-Quartile Range)
Unit of Measure: percentage
99
(98 to 99)
98
(97 to 99)
99
(98 to 99)
17.Secondary Outcome
Title Oxygen Saturation by Pulse After Withdrawal of Cystoscope
Hide Description [Not Specified]
Time Frame after withdrawal of cystoscope
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Median (Inter-Quartile Range)
Unit of Measure: percentage
99
(98 to 99)
98
(98 to 99)
99
(98 to 99)
18.Secondary Outcome
Title Breath Rate Before Gel Administration
Hide Description [Not Specified]
Time Frame before gel administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Mean (Standard Deviation)
Unit of Measure: times per minute
19.8  (1.1) 19.6  (1.6) 19.5  (1.3)
19.Secondary Outcome
Title Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra
Hide Description [Not Specified]
Time Frame at cystoscopic inspection of penile and bulbar Urthra
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Mean (Standard Deviation)
Unit of Measure: times per minute
20.0  (1.2) 19.8  (1.5) 19.6  (1.3)
20.Secondary Outcome
Title Breath Rate at Cystoscopic Inspection of External Sphincter
Hide Description [Not Specified]
Time Frame at cystoscopic inspection of external sphincter
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Mean (Standard Deviation)
Unit of Measure: times per minute
20.1  (1.3) 19.8  (1.7) 19.8  (1.5)
21.Secondary Outcome
Title Breath Rate After Withdrawal of Cystoscope
Hide Description [Not Specified]
Time Frame after withdrawal of cystoscope
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine Gel Group Dorsal Penile Nerve Block Group Combination Group
Hide Arm/Group Description:

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 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

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 Number of Participants Analyzed 86 86 86
Mean (Standard Deviation)
Unit of Measure: times per minute
19.7  (1.2) 19.4  (1.5) 19.4  (1.2)
Time Frame from beginning of dorsal penile nerve block to end of cystoscopy
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tetracaine Group DPNB Group Combination Group
Hide Arm/Group Description tetracaine gel plus DPNB with saline DPNB with ropivacaine plus plain lubricant DPNB with ropivacaine plus tetracaine gel
All-Cause Mortality
Tetracaine Group DPNB Group Combination Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tetracaine Group DPNB Group Combination Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/86 (0.00%)   0/86 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tetracaine Group DPNB Group Combination Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/86 (0.00%)   0/86 (0.00%) 
The VAS scale was the only main observe index, and patients could have different cognition of pain and this may affect the evaluation of pain. The nerve block was not guided by ultrasound, which may improve the analgesic effect.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Guizhi Du, Associate professor
Organization: West China Hospital, Department of Anesthesiology
Phone: +86 18980602213
EMail: du_guizhi@yahoo.com
Publications:
Layout table for additonal information
Responsible Party: Yan Qiu, West China Hospital
ClinicalTrials.gov Identifier: NCT02502487     History of Changes
Other Study ID Numbers: WestChinaHAesthesia-1
First Submitted: July 6, 2015
First Posted: July 20, 2015
Results First Submitted: April 14, 2016
Results First Posted: July 11, 2016
Last Update Posted: August 15, 2016