Indwelling Urinary CatheterPhase 3NCT01721031
DPNB for Prevention of CRDB
A Phase 3 study testing DPNB and Tramadol in people with Indwelling Urinary Catheter and Male Patients, run by West China Hospital at 1 site in China.
Trial summary
Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is defined as an urge to void or discomfort in the supra-pubic region. This symptom complex may cause patient agitated and exacerbated postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Indwelling Urinary Catheter, Male Patients, General Anesthesia
- What is being tested?
- DPNB and Tramadol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2013to 15 Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent signed
- Male adult patient, aged 18~50 years old, ASA I~III
- Surgery under general anesthesia
Who cannot join
- Bladder dysfunction, such as overactive bladder
- A history of bladder outflow obstruction
- Prostate disease, such as benign prostate hyperplasia, etc.
- Disturbance of central nervous system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Dorsal Penile Nerve Block With 0.33% Ropivacaine and Intravenous Tramadol for Prevention of Catheter-related Bladder Discomfort: Study Protocol for a Randomized Controlled Trial
Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is defined as an urge to void or discomfort in the supra-pubic region. This symptom complex may cause patient agitated and exacerbated postoperative pain. In clinic, dorsal penile nerve block (DPNB) was applied for penile surgery including circumcision and some anterior urethra surgery. The investigators hypothesize that DPNB relive CRBD for male patients with indwelling urinary catheter under general anesthesia.
Read the detailed description
CRBD is not uncommon in the postoperative period, especially in male patients who have had urinary catheterization after anesthetic induction under general anesthesia, and this symptom complex may cause patient agitated and exacerbated postoperative pain. According to the previous study, i.v. tramadol 1.5 mg/kg administered 30 min before extubation results in reduction in the incidence and severity of CRBD. In clinical practice, tramadol is associated with side effects including nausea, vomiting, sedation, etc. Clinically, dorsal penile nerve block (DPNB) was applied in penile surgery, and got satisfactory pain relief effect postoperatively without side effects related to tramadol. Besides, we observed patients underwent urethra surgery with urinary catheter left in situ seldom complained of CRBD if DPNB and RB performed at the end of operation. We hypothesized that DPNB could relieve DPNB for male patient with indwelling urinary catheter insertion after induction of general anesthesia.
In this study we compare the efficacy of dorsal penile nerve block (DPNB) with 0.33% ropivacaine and intravenous tramadol 1.5mg/kg in prevention of CRBD, as well as the incidences of side effects postoperatively.
- Being tested
- DPNB, Tramadol
- Keywords
- Catheter Related Bladder Discomfort, Dorsal Penile Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPNBProcedure or surgery
Patients receive DPNB 30min before extubation at the end of operation
TramadolDrug
Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation.
| Study group | Role | What they receive |
|---|---|---|
| DPNB | Experimental | Patients receive DPNB 30min before extubation at the end of operation. Receives: Procedure: DPNB |
| Tramadol | Active comparator | Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation. Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of CRBD
Measured: up to 6 months
Secondary outcomes (3)
Visual analogue scale (VAS) for postoperative pain
Measured: up to 6 months
Postoperative fentanyl requirement
Measured: up to 6 months
Side effects
- the level of sedation.
- postoperative nausea vomiting (PONV)
- incidence of respiratory depression
- incidence of agitation, and delirium
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study start1 Apr 2013
- Primary completion1 Dec 2015
- Study completion15 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Indwelling Urinary CatheterStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Liao, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721031
- Sponsor's protocol ID
- DPNB120928
- Other IDs
- LRWCHA
- Status last verified
- Sep 2018
- First submitted
- 27 Oct 2012
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li JY, Yi ML, Liao R. Dorsal Penile Nerve Block With Ropivacaine-Reduced Postoperative Catheter-Related Bladder Discomfort in Male Patients After Emergence of General Anesthesia: A Prospective, Randomized, Controlled Study. Medicine (Baltimore). 2016 Apr;95(15):e3409. doi: 10.1097/MD.0000000000003409.
PubMed 27082620Li JY, Liao R. Dorsal penile nerve block with ropivacaine versus intravenous tramadol for the prevention of catheter-related bladder discomfort: study protocol for a randomized controlled trial. Trials. 2015 Dec 30;16:596. doi: 10.1186/s13063-015-1130-2.
PubMed 26715519
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dorsal Penile Nerve Block With 0.33% Ropivacaine and Intravenous Tramadol for Prevention of Catheter-related Bladder Discomfort: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01721031
- Acronym / sponsor ID
- DPNB120928
- Keywords
- Catheter Related Bladder Discomfort, Dorsal Penile Nerve Block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 15 Dec 2015 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is defined as an urge to void or discomfort in the supra-pubic region. This symptom complex may cause patient agitated and exacerbated postoperative pain. In clinic, dorsal penile nerve block (DPNB) was applied for penile surgery including circumcision and some anterior urethra surgery. The investigators hypothesize that DPNB relive CRBD for male patients with indwelling urinary catheter under general anesthesia.
Detailed description
CRBD is not uncommon in the postoperative period, especially in male patients who have had urinary catheterization after anesthetic induction under general anesthesia, and this symptom complex may cause patient agitated and exacerbated postoperative pain. According to the previous study, i.v. tramadol 1.5 mg/kg administered 30 min before extubation results in reduction in the incidence and severity of CRBD. In clinical practice, tramadol is associated with side effects including nausea, vomiting, sedation, etc. Clinically, dorsal penile nerve block (DPNB) was applied in penile surgery, and got satisfactory pain relief effect postoperatively without side effects related to tramadol. Besides, we observed patients underwent urethra surgery with urinary catheter left in situ seldom complained of CRBD if DPNB and RB performed at the end of operation. We hypothesized that DPNB could relieve DPNB for male patient with indwelling urinary catheter insertion after induction of general anesthesia.
In this study we compare the efficacy of dorsal penile nerve block (DPNB) with 0.33% ropivacaine and intravenous tramadol 1.5mg/kg in prevention of CRBD, as well as the incidences of side effects postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DPNB | Experimental | Procedure: DPNBPatients receive DPNB 30min before extubation at the end of operation. |
| Tramadol | Active comparator | Drug: TramadolPatients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Informed consent signed
- Male adult patient, aged 18~50 years old, ASA I~III
- Surgery under general anesthesia
Key exclusion criteria (4 listed)
- Bladder dysfunction, such as overactive bladder
- A history of bladder outflow obstruction
- Prostate disease, such as benign prostate hyperplasia, etc.
- Disturbance of central nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPNBPatients receive DPNB 30min before extubation at the end of operation | Procedure or surgery | DPNB |
| TramadolPatients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation. | Drug | Tramadol |
Primary outcome
Incidence and severity of CRBD
Time frame: up to 6 months
3 secondary outcomes
Visual analogue scale (VAS) for postoperative pain
Time frame: up to 6 months
Postoperative fentanyl requirement
Time frame: up to 6 months
Side effects
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Derived from this study: PubMed 27082620Li JY, Yi ML, Liao R. Dorsal Penile Nerve Block With Ropivacaine-Reduced Postoperative Catheter-Related Bladder Discomfort in Male Patients After Emergence of General Anesthesia: A Prospective, Randomized, Controlled Study. Medicine (Baltimore). 2016 Apr;95(15):e3409. doi: 10.1097/MD.0000000000003409.
- Derived from this study: PubMed 26715519Li JY, Liao R. Dorsal penile nerve block with ropivacaine versus intravenous tramadol for the prevention of catheter-related bladder discomfort: study protocol for a randomized controlled trial. Trials. 2015 Dec 30;16:596. doi: 10.1186/s13063-015-1130-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DPNB and Tramadol in people with Indwelling Urinary Catheter and Male Patients, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of CRBD (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01721031, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.