Prostate CancerPhase 1/2NCT01565512
Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort
A Phase 1/2 study testing Bupivacaine and Saline in people with Prostate Cancer and Robotic Prostatectomy, run by Columbia University at 1 site in United States.
Trial summary
The indwelling urethral foley is a major source of discomfort following radical prostatectomy. Our hypothesis is that intra-operative dorsal penile nerve block with bupivacaine may decrease immediate post-operative foley discomfort. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Robotic Prostatectomy, Foley Catheter Discomfort
- What is being tested?
- Bupivacaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jul 2014
- Phase
- Phase 1/2
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 40 years and above,
- diagnosis of prostate cancer,
- electing to undergo robot-assisted radical prostatectomy
Who cannot join
- allergy to bupivacaine or amide-type local anesthetics,
- chronic pain condition,
- recently or currently on narcotics,
- genital abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital/Columbia University
New York, New York, 10032
About this study
Official title: Randomized Trial to Determine the Effect of Dorsal Penile Block on Post-Robotic Prostatectomy Foley Discomfort
The indwelling urethral foley is a major source of discomfort following radical prostatectomy. Our hypothesis is that intra-operative dorsal penile nerve block with bupivacaine may decrease immediate post-operative foley discomfort.
Read the detailed description
Patients undergoing robot-assisted radical prostatectomy (RARP) will be randomized in a double-blind placebo controlled manner to undergo penile ring block injection at the time of skin incision closure. A visual analog scale (VAS) based questionnaire including newly developed foley discomfort scores will be administered at various time points post-operatively.
- Being tested
- Bupivacaine, Saline
- Keywords
- randomized trial, robotic prostatectomy, prostate cancer, foley catheter discomfort
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
A total of 100 mg bupivacaine (20 mL of 5 mg/mL solution) administered once by subcutaneous injection while patient is under general anesthesia at end of operation.
SalineDrug
A total of 20 mL on injectable saline(0.9% NS) administered once by subcutaneous injection while patient is under general anesthesia at end of operation.
| Study group | Role | What they receive |
|---|---|---|
| saline injection | Placebo comparator | saline injection Receives: Drug: Saline |
| Bupivacaine injection | Active comparator | penile block with bupivacaine Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of pain/discomfort
Measured: postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Lack of funding, PI left the institution, poor enrollment
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 Columbia UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ketan K. Badani, M.D., Principal investigator, Assistant Professor, Department of Urology, New York Presbyterian Hospital, Columbia University Medical CenterChris O. Wambi, M.D., Study chair, Department of Urology, New York Presbyterian Hospital, Columbia University Medical CenterMitchell C. Benson, M.D., Study director, Professor and Chairman, Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565512
- Sponsor's protocol ID
- AAAI5060
- Status last verified
- Mar 2015
- First submitted
- 26 Mar 2012
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Determine the Effect of Dorsal Penile Block on Post-Robotic Prostatectomy Foley Discomfort
- ClinicalTrials.gov ID
- NCT01565512
- Acronym / sponsor ID
- AAAI5060
- Keywords
- randomized trial, robotic prostatectomy, prostate cancer, foley catheter discomfort
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding, PI left the institution, poor enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 28 Mar 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.
The indwelling urethral foley is a major source of discomfort following radical prostatectomy. Our hypothesis is that intra-operative dorsal penile nerve block with bupivacaine may decrease immediate post-operative foley discomfort.
Detailed description
Patients undergoing robot-assisted radical prostatectomy (RARP) will be randomized in a double-blind placebo controlled manner to undergo penile ring block injection at the time of skin incision closure. A visual analog scale (VAS) based questionnaire including newly developed foley discomfort scores will be administered at various time points post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saline injection | Placebo comparator | Drug: Salinesaline injection |
| Bupivacaine injection | Active comparator | Drug: Bupivacainepenile block with bupivacaine |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 40 years and above,
- diagnosis of prostate cancer,
- electing to undergo robot-assisted radical prostatectomy
Key exclusion criteria (4 listed)
- allergy to bupivacaine or amide-type local anesthetics,
- chronic pain condition,
- recently or currently on narcotics,
- genital abnormalities
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 |
|---|---|---|
| BupivacaineA total of 100 mg bupivacaine (20 mL of 5 mg/mL solution) administered once by subcutaneous injection while patient is under general anesthesia at end of operation. | Drug | Bupivacaine injection |
| SalineA total of 20 mL on injectable saline(0.9% NS) administered once by subcutaneous injection while patient is under general anesthesia at end of operation. | Drug | saline injection |
Primary outcome
Prevalence of pain/discomfort
Time frame: postoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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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.
Ketan K. Badani, M.D. principal investigator
Assistant Professor, Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
Chris O. Wambi, M.D. study chair
Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
Mitchell C. Benson, M.D. study director
Professor and Chairman, Department of Urology, New York Presbyterian Hospital, Columbia University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bupivacaine and Saline in people with Prostate Cancer and Robotic Prostatectomy, run by Columbia University at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 5 Mar 2015. 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 United States. 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Prevalence of pain/discomfort (time frame: postoperative). 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 5 Mar 2015.