Prostate CancerPhase 4NCT05957653
Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort
A Phase 4 study testing lidocaine and sufentanil and Saline in people with Prostate Cancer, run by RenJi Hospital.
Trial summary
The goal of this clinical trial is to evaluate the incidence and severity of postoperative catheter-related bladder discomfort after robot-assisted radical prostatectomy. The main question it aims to answer is to evaluate incidence of CRBD immediately after extubation in resuscitation. Read more about this study
- Who is it for?
- Ages 18 to 79 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- lidocaine and sufentanil and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 7 Oct 2023to 30 Oct 2025
- Phase
- Phase 4
- 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 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-79 years, ASA class I-II
- participants undergoing robot-assisted radical prostatectomy under general anesthesia
- signed informed consent and volunteered to participate in the experiment
Who cannot join
- urethral stricture, difficulty in inserting catheter or urethral bleeding during catheterization
- a preexisting bladder disease such as an overactive bladder, bladder outflow obstruction, and neurogenic bladder
- cognitive impairment or communication disorders
- severe heart, lung, liver, kidney and immune system diseases
- confirmed or suspected allergy to this trial drug
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort After Robot-assisted Radical Prostatectomy: a Randomized, Double-blind, Controlled Trial
The goal of this clinical trial is to evaluate the incidence and severity of postoperative catheter-related bladder discomfort after robot-assisted radical prostatectomy.
The main question it aims to answer is to evaluate incidence of CRBD immediately after extubation in resuscitation.
A total of 20ml of 2% lidocaine and 1μg/ml sufentanil or 20ml normal saline was injected into the bladder of the participants through the catheter. After drug injection, the catheter was clamped for 20 minutes, and then 100ml normal saline was injected into the bladder through the catheter to flush out.
Then, the incidence of CRBD was compared between the two groups.
- Conditions
- Prostate Cancer
- Being tested
- lidocaine and sufentanil, Saline
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine and sufentanilDrug
A total of 20ml of 2% lidocaine and 1μg/ml sufentanil was injected into the bladder through the catheter.
SalineDrug
A total of 20ml normal saline was injected into the bladder through the catheter.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine + sufentanil intervention group | Experimental | Not described Receives: Drug: lidocaine and sufentanil |
| Saline control group | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of CRBD
incidence of CRBD
Measured: immediately after extubation in resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start7 Oct 2023 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by RenJi 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhuhao, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957653
- Sponsor's protocol ID
- IIT-2023-0092
- Status last verified
- Jul 2023
- First submitted
- 15 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort After Robot-assisted Radical Prostatectomy: a Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT05957653
- Acronym / sponsor ID
- IIT-2023-0092
- Conditions
- Prostate Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 7 Oct 2023 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 24 Jul 2023 (actual)
- 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.
The goal of this clinical trial is to evaluate the incidence and severity of postoperative catheter-related bladder discomfort after robot-assisted radical prostatectomy.
The main question it aims to answer is to evaluate incidence of CRBD immediately after extubation in resuscitation.
A total of 20ml of 2% lidocaine and 1μg/ml sufentanil or 20ml normal saline was injected into the bladder of the participants through the catheter. After drug injection, the catheter was clamped for 20 minutes, and then 100ml normal saline was injected into the bladder through the catheter to flush out.
Then, the incidence of CRBD was compared between the two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine + sufentanil intervention group | Experimental | Drug: lidocaine and sufentanil |
| Saline control group | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18-79 years, ASA class I-II
- participants undergoing robot-assisted radical prostatectomy under general anesthesia
- signed informed consent and volunteered to participate in the experiment
Key exclusion criteria (5 listed)
- urethral stricture, difficulty in inserting catheter or urethral bleeding during catheterization
- a preexisting bladder disease such as an overactive bladder, bladder outflow obstruction, and neurogenic bladder
- cognitive impairment or communication disorders
- severe heart, lung, liver, kidney and immune system diseases
- confirmed or suspected allergy to this trial drug
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 |
|---|---|---|
| lidocaine and sufentanilA total of 20ml of 2% lidocaine and 1μg/ml sufentanil was injected into the bladder through the catheter. | Drug | Lidocaine + sufentanil intervention group |
| SalineA total of 20ml normal saline was injected into the bladder through the catheter. | Drug | Saline control group |
Primary outcome
incidence of CRBD
Time frame: immediately after extubation in resuscitation
incidence of CRBD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lidocaine and sufentanil and Saline in people with Prostate Cancer, run by RenJi Hospital.
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 5 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: status not confirmed, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Zhu (008602168383702, zhuhaossmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of CRBD (time frame: immediately after extubation in resuscitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2023.