Pain
Conditions
Keywords
Analgesia, Cystoscopy, Dorsal nerve of penis, Nerve block, Ropivacaine
Brief summary
This study will determine the effectiveness and safety of dorsal penile nerve block (DPNB) in men undergoing rigid cystoscopy.
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.
Interventions
PROCEDUREDorsal 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
DRUGRopivacaine
0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
DRUGTetracaine
1% Tetracaine gel instilled into urethra
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Breath Rate After Withdrawal of Cystoscope | after withdrawal of cystoscope | — |
| Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra | at cystoscopic inspection of penile and bulbar Urthra | — |
| Visual Analog Scale (VAS) for Pain | 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. |
| Heart Rate Before Gel Administration | before gel administration | — |
| Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra | at cystoscopic inspection of penile and bulbar urethra | — |
| Heart Rate at Cystoscopic Inspection of External Sphincter | at cystoscopic inspection of external sphincter | — |
| Heart Rate After Withdrawal of Cystoscope | after withdrawal of cystoscope | — |
| Mean Arterial Pressure Before Gel Administration | before gel administration | — |
| Breath Rate at Cystoscopic Inspection of External Sphincter | at cystoscopic inspection of external sphincter | — |
| Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter | at cystoscopic inspection of external sphincter | — |
| Mean Arterial Pressure After Withdrawal of Cystoscope | after withdrawal of cystoscope | — |
| Oxygen Saturation by Pulse Before Gel Administration | before gel administration | — |
| Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra | at cystoscopic inspection of penile and bulbar urthra | — |
| Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter | at cystoscopic inspection of external sphincter | — |
| Oxygen Saturation by Pulse After Withdrawal of Cystoscope | after withdrawal of cystoscope | — |
| Breath Rate Before Gel Administration | before gel administration | — |
| Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra | at cystoscopic inspection of penile and bulbar urthra | — |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tetracaine Gel Group Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy
Tetracaine: 1% Tetracaine gel instilled into urethra | 86 |
| 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 | 86 |
| 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 | 86 |
| Total | 258 |
Baseline characteristics
| Characteristic | Tetracaine Gel Group | Dorsal Penile Nerve Block Group | Combination Group | Total |
|---|---|---|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 11.5 | 52.1 years STANDARD_DEVIATION 13 | 53.5 years STANDARD_DEVIATION 12 | 53.0 years STANDARD_DEVIATION 12.2 |
| Body mass index | 23.8 Kg/m^2 STANDARD_DEVIATION 2.4 | 24.2 Kg/m^2 STANDARD_DEVIATION 3 | 23.6 Kg/m^2 STANDARD_DEVIATION 2.7 | 23.8 Kg/m^2 STANDARD_DEVIATION 2.7 |
| Body weight | 66.8 Kg STANDARD_DEVIATION 8.2 | 68.8 Kg STANDARD_DEVIATION 9.6 | 66.4 Kg STANDARD_DEVIATION 8.9 | 67.3 Kg STANDARD_DEVIATION 8.9 |
| Cystoscopy history First-time cystoscopy | 60 participants | 58 participants | 61 participants | 179 participants |
| Cystoscopy history Repeat cystoscopy | 26 participants | 28 participants | 25 participants | 79 participants |
| Duration of cystoscopy | 3.5 min STANDARD_DEVIATION 0.6 | 3.5 min STANDARD_DEVIATION 0.5 | 3.4 min STANDARD_DEVIATION 0.5 | 3.5 min STANDARD_DEVIATION 0.6 |
| Height | 167.3 cm STANDARD_DEVIATION 5.6 | 168.7 cm STANDARD_DEVIATION 5.5 | 167.8 cm STANDARD_DEVIATION 6.4 | 167.9 cm STANDARD_DEVIATION 5.8 |
| Sex/Gender, Customized Male | 86 participants | 86 participants | 86 participants | 258 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 86 | 0 / 86 | 0 / 86 |
| serious Total, serious adverse events | 0 / 86 | 0 / 86 | 0 / 86 |
Outcome results
Primary
Visual Analog Scale (VAS) for Pain
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tetracaine Gel Group | Visual Analog Scale (VAS) for Pain | 6 units on a scale |
| Dorsal Penile Nerve Block Group | Visual Analog Scale (VAS) for Pain | 4 units on a scale |
| Combination Group | Visual Analog Scale (VAS) for Pain | 4 units on a scale |
Secondary
Breath Rate After Withdrawal of Cystoscope
Time frame: after withdrawal of cystoscope
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetracaine Gel Group | Breath Rate After Withdrawal of Cystoscope | 19.7 times per minute | Standard Deviation 1.2 |
| Dorsal Penile Nerve Block Group | Breath Rate After Withdrawal of Cystoscope | 19.4 times per minute | Standard Deviation 1.5 |
| Combination Group | Breath Rate After Withdrawal of Cystoscope | 19.4 times per minute | Standard Deviation 1.2 |
Secondary
Breath Rate at Cystoscopic Inspection of External Sphincter
Time frame: at cystoscopic inspection of external sphincter
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetracaine Gel Group | Breath Rate at Cystoscopic Inspection of External Sphincter | 20.1 times per minute | Standard Deviation 1.3 |
| Dorsal Penile Nerve Block Group | Breath Rate at Cystoscopic Inspection of External Sphincter | 19.8 times per minute | Standard Deviation 1.7 |
| Combination Group | Breath Rate at Cystoscopic Inspection of External Sphincter | 19.8 times per minute | Standard Deviation 1.5 |
Secondary
Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra
Time frame: at cystoscopic inspection of penile and bulbar Urthra
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetracaine Gel Group | Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra | 20.0 times per minute | Standard Deviation 1.2 |
| Dorsal Penile Nerve Block Group | Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra | 19.8 times per minute | Standard Deviation 1.5 |
| Combination Group | Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra | 19.6 times per minute | Standard Deviation 1.3 |
Secondary
Breath Rate Before Gel Administration
Time frame: before gel administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetracaine Gel Group | Breath Rate Before Gel Administration | 19.8 times per minute | Standard Deviation 1.1 |
| Dorsal Penile Nerve Block Group | Breath Rate Before Gel Administration | 19.6 times per minute | Standard Deviation 1.6 |
| Combination Group | Breath Rate Before Gel Administration | 19.5 times per minute | Standard Deviation 1.3 |
Secondary
Heart Rate After Withdrawal of Cystoscope
Time frame: after withdrawal of cystoscope
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetracaine Gel Group | Heart Rate After Withdrawal of Cystoscope | 76.7 Beats per minute | Standard Deviation 10.9 |
| Dorsal Penile Nerve Block Group | Heart Rate After Withdrawal of Cystoscope | 72.3 Beats per minute | Standard Deviation 10 |
| Combination Group | Heart Rate After Withdrawal of Cystoscope | 71.6 Beats per minute | Standard Deviation 9.2 |
Secondary
Heart Rate at Cystoscopic Inspection of External Sphincter
Time frame: at cystoscopic inspection of external sphincter
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetracaine Gel Group | Heart Rate at Cystoscopic Inspection of External Sphincter | 96.7 Beats per minute | Standard Deviation 14.1 |
| Dorsal Penile Nerve Block Group | Heart Rate at Cystoscopic Inspection of External Sphincter | 90.2 Beats per minute | Standard Deviation 14.9 |
| Combination Group | Heart Rate at Cystoscopic Inspection of External Sphincter | 86.2 Beats per minute | Standard Deviation 10.9 |
Secondary
Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra
Time frame: at cystoscopic inspection of penile and bulbar urethra
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetracaine Gel Group | Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra | 84.8 Beats per minute | Standard Deviation 11.7 |
| Dorsal Penile Nerve Block Group | Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra | 83.8 Beats per minute | Standard Deviation 12 |
| Combination Group | Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra | 81.1 Beats per minute | Standard Deviation 10.4 |
Secondary
Heart Rate Before Gel Administration
Time frame: before gel administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetracaine Gel Group | Heart Rate Before Gel Administration | 75.0 Beats per minute | Standard Deviation 9.7 |
| Dorsal Penile Nerve Block Group | Heart Rate Before Gel Administration | 75.9 Beats per minute | Standard Deviation 9.4 |
| Combination Group | Heart Rate Before Gel Administration | 73.6 Beats per minute | Standard Deviation 10.2 |
Secondary
Mean Arterial Pressure After Withdrawal of Cystoscope
Time frame: after withdrawal of cystoscope
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetracaine Gel Group | Mean Arterial Pressure After Withdrawal of Cystoscope | 99.3 mmHg | Standard Deviation 9.8 |
| Dorsal Penile Nerve Block Group | Mean Arterial Pressure After Withdrawal of Cystoscope | 95.7 mmHg | Standard Deviation 8.4 |
| Combination Group | Mean Arterial Pressure After Withdrawal of Cystoscope | 95.2 mmHg | Standard Deviation 8.6 |
Secondary
Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter
Time frame: at cystoscopic inspection of external sphincter
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetracaine Gel Group | Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter | 113.7 mmHg | Standard Deviation 11.7 |
| Dorsal Penile Nerve Block Group | Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter | 105.8 mmHg | Standard Deviation 10.5 |
| Combination Group | Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter | 104.8 mmHg | Standard Deviation 9.2 |
Secondary
Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra
Time frame: at cystoscopic inspection of penile and bulbar urthra
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetracaine Gel Group | Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra | 100 mmHg | Standard Deviation 10.6 |
| Dorsal Penile Nerve Block Group | Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra | 99.8 mmHg | Standard Deviation 10.1 |
| Combination Group | Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra | 98.2 mmHg | Standard Deviation 9 |
Secondary
Mean Arterial Pressure Before Gel Administration
Time frame: before gel administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetracaine Gel Group | Mean Arterial Pressure Before Gel Administration | 95.3 mmHg | Standard Deviation 10.2 |
| Dorsal Penile Nerve Block Group | Mean Arterial Pressure Before Gel Administration | 96.6 mmHg | Standard Deviation 9.7 |
| Combination Group | Mean Arterial Pressure Before Gel Administration | 95.1 mmHg | Standard Deviation 9.9 |
Secondary
Oxygen Saturation by Pulse After Withdrawal of Cystoscope
Time frame: after withdrawal of cystoscope
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tetracaine Gel Group | Oxygen Saturation by Pulse After Withdrawal of Cystoscope | 99 percentage |
| Dorsal Penile Nerve Block Group | Oxygen Saturation by Pulse After Withdrawal of Cystoscope | 98 percentage |
| Combination Group | Oxygen Saturation by Pulse After Withdrawal of Cystoscope | 99 percentage |
Secondary
Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter
Time frame: at cystoscopic inspection of external sphincter
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tetracaine Gel Group | Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter | 99 percentage |
| Dorsal Penile Nerve Block Group | Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter | 98 percentage |
| Combination Group | Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter | 99 percentage |
Secondary
Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra
Time frame: at cystoscopic inspection of penile and bulbar urthra
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tetracaine Gel Group | Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra | 99 percentage |
| Dorsal Penile Nerve Block Group | Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra | 98 percentage |
| Combination Group | Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra | 99 percentage |
Secondary
Oxygen Saturation by Pulse Before Gel Administration
Time frame: before gel administration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tetracaine Gel Group | Oxygen Saturation by Pulse Before Gel Administration | 99 percentage |
| Dorsal Penile Nerve Block Group | Oxygen Saturation by Pulse Before Gel Administration | 98 percentage |
| Combination Group | Oxygen Saturation by Pulse Before Gel Administration | 99 percentage |
Secondary
Visual Analog Scale (VAS) for Pain
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tetracaine Gel Group | Visual Analog Scale (VAS) for Pain | 0 units on a scale |
| Dorsal Penile Nerve Block Group | Visual Analog Scale (VAS) for Pain | 0 units on a scale |
| Combination Group | Visual Analog Scale (VAS) for Pain | 0 units on a scale |
Secondary
Visual Analog Scale (VAS) for Pain
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tetracaine Gel Group | Visual Analog Scale (VAS) for Pain | 2 units on a scale |
| Dorsal Penile Nerve Block Group | Visual Analog Scale (VAS) for Pain | 0 units on a scale |
| Combination Group | Visual Analog Scale (VAS) for Pain | 0 units on a scale |
Secondary
Visual Analog Scale (VAS) for Pain
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tetracaine Gel Group | Visual Analog Scale (VAS) for Pain | 0 units on a scale |
| Dorsal Penile Nerve Block Group | Visual Analog Scale (VAS) for Pain | 0 units on a scale |
| Combination Group | Visual Analog Scale (VAS) for Pain | 0 units on a scale |
Secondary
Visual Analog Scale (VAS) for Pain
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tetracaine Gel Group | Visual Analog Scale (VAS) for Pain | 1 units on a scale |
| Dorsal Penile Nerve Block Group | Visual Analog Scale (VAS) for Pain | 1 units on a scale |
| Combination Group | Visual Analog Scale (VAS) for Pain | 1 units on a scale |