Erectile DysfunctionPhase 4ROVEX-IPPNCT04801368
Randomized Trial of Ropivacaine & Bupivacaine for Inflatable Penile Prosthesis
A Phase 4 study testing Randomization of two local anesthetics. in people with Erectile Dysfunction, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to determine the effects of penile ring block for local anesthesia with liposomal bupivacaine vs ropivacaine mixture in subjects undergoing surgery for Penile Prosthesis Placement. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Randomization of two local anesthetics.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 8 Jan 2024
- Phase
- Phase 4
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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men undergoing 3-piece penile prosthesis placement under general anesthesia at Mayo Clinic - Rochester.
- ≥ 18 years old.
Who cannot join
- History of opioid exposure within the preceding 90 days prior to surgery (based on patient-report, review of the electronic medical record, and NMP prescribing database review)
- Current or prior history of alcohol or drug abuse (illicit or prescription)
- History of chronic pain conditions (chronic musculoskeletal pain, fibromyalgia, central sensitization, chronic pelvic pain syndrome, etc.)
- History of cardiac arrhythmia or untreated severe cardiovascular disease
- Uncontrolled hypertension
- Hepatic insufficiency
Show all 16Show fewer
- Renal insufficiency (CKD stage IIIa or greater)
- Current anti-platelet or anti-coagulation therapy with plans to continue at the time of prosthesis placement
- Poorly controlled diabetes mellitus (defined as HgbA1c > 8.5 within 30 days of surgery)
- Concurrent adjunctive operative procedures planned at the time of penile prosthesis placement (examples: male urethral sling, Peyronie's disease straightening with penile plication or incision/grafting)
- Concurrent non-prosthetic surgery planned at the time of penile prosthesis placement (examples: circumcision, hernia repair, hydrocelectomy, etc.)
- Planned infrapubic or subcoronal incision at the time of penile prosthesis placement
- Patients who will be undergoing prosthesis placement using local, monitored, or spinal anesthesia (i.e. non-general anesthesia)
- Allergy or history of intolerance to any local anesthetic agents included in the protocol
- History of prior penile prosthesis or artificial urinary sphincter surgery
- Revision penile prosthesis surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Randomized-Controlled Trial Comparing Long-acting and Short-acting Local Anesthetics at the Time of Penile Prosthesis Placement
The purpose of this research is to determine the effects of penile ring block for local anesthesia with liposomal bupivacaine vs ropivacaine mixture in subjects undergoing surgery for Penile Prosthesis Placement.
- Conditions
- Erectile Dysfunction
- Being tested
- Randomization of two local anesthetics.
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomization of two local anesthetics.Drug
Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Receiving Ropivacaine | Experimental | Patients receiving Ropivacaine. Receives: Drug: Randomization of two local anesthetics. |
| Receiving Liposomal Bupivacaine | Experimental | Patients receiving Liposomal Bupivacaine. Receives: Drug: Randomization of two local anesthetics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual-analogue Pain Scale
Visual-analogue pain scale is a tool used to measure pain intensity at a specific timepoint, asking a patient to use visuals to rate their pain on a scale of 1 to 10.
Results are reported as units on a scale, minimum 1 (experiencing the least amount of pain possible) to maximum of 10 (experiencing an unbearably high amount of pain).
Lower scores provide a better outcome for the patient as they are experiencing less pain post-operatively.
Measured: post-operative day 3
Visual-analogue Pain Scale
Visual-analogue pain scale is a tool used to measure pain intensity at a specific timepoint, asking a patient to use visuals to rate their pain on a scale of 1 to 10.
Results are reported as units on a scale, minimum 1 (experiencing the least amount of pain possible) to maximum of 10 (experiencing an unbearably high amount of pain).
Lower scores provide a better outcome for the patient as they are experiencing less pain post-operatively.
Measured: post-operative day 7
Visual-analogue Pain Scale
Visual-analogue pain scale is a tool used to measure pain intensity at a specific timepoint, asking a patient to use visuals to rate their pain on a scale of 1 to 10.
Results are reported as units on a scale, minimum 1 (experiencing the least amount of pain possible) to maximum of 10 (experiencing an unbearably high amount of pain).
Lower scores provide a better outcome for the patient as they are experiencing less pain post-operatively.
Measured: post-operative day 14
Visual-analogue Anxiety Scale
Visual-analogue anxiety scale is a tool used to measure anxiety intensity at a specific timepoint, asking a patient to use visuals to rate their current anxiety on a scale of 1 to 10.
Results are reported as units on a scale, minimum 1 (experiencing the least amount of anxiety possible) to maximum of 10 (experiencing an unbearably high amount of anxiety).
Lower scores provide a better outcome for the patient as they are experiencing less anxiety post-operatively.
Measured: post-operative day 3
Visual-analogue Anxiety Scale
Visual-analogue anxiety scale is a tool used to measure anxiety intensity at a specific timepoint, asking a patient to use visuals to rate their current anxiety on a scale of 1 to 10.
Results are reported as units on a scale, minimum 1 (experiencing the least amount of anxiety possible) to maximum of 10 (experiencing an unbearably high amount of anxiety).
Lower scores provide a better outcome for the patient as they are experiencing less anxiety post-operatively.
Measured: post-operative day 7
Visual-analogue Anxiety Scale
Visual-analogue anxiety scale is a tool used to measure anxiety intensity at a specific timepoint, asking a patient to use visuals to rate their current anxiety on a scale of 1 to 10.
Results are reported as units on a scale, minimum 1 (experiencing the least amount of anxiety possible) to maximum of 10 (experiencing an unbearably high amount of anxiety).
Lower scores provide a better outcome for the patient as they are experiencing less anxiety post-operatively.
Measured: post-operative day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Oct 2021
- Primary completion7 Jan 2024
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The two anesthetics being used in the study are FDA approved and used in standard practice for the procedure. Subjects will be blindly assigned to one of two study groups at the initial phase of the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew (Matt) J. Ziegelmann, Mayo Clinic
- Investigators
- Matthew J Ziegelmann, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801368
- Sponsor's protocol ID
- 20-010842
- Acronym
- ROVEX-IPP
- Status last verified
- Jan 2025
- First submitted
- 19 Feb 2021
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No