Randomized Trial of Ropivacaine & Bupivacaine for Inflatable Penile Prosthesis (ROVEX-IPP)
A Randomized-Controlled Trial Comparing Long-acting and Short-acting Local Anesthetics at the Time of Penile Prosthesis Placement
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men undergoing 3-piece penile prosthesis placement under general anesthesia at Mayo Clinic - Rochester.
- ≥ 18 years old.
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Receiving Ropivacaine
Patients receiving Ropivacaine.
|
Patients will be blinded and randomized to two different arms.
One receiving ropivacaine, one receiving liposomal bupivacaine.
|
|
Experimental: Receiving Liposomal Bupivacaine
Patients receiving Liposomal Bupivacaine.
|
Patients will be blinded and randomized to two different arms.
One receiving ropivacaine, one receiving liposomal bupivacaine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual-analogue Pain Scale
Time Frame: post-operative day 3
|
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. |
post-operative day 3
|
|
Visual-analogue Pain Scale
Time Frame: post-operative day 7
|
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. |
post-operative day 7
|
|
Visual-analogue Pain Scale
Time Frame: post-operative day 14
|
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. |
post-operative day 14
|
|
Visual-analogue Anxiety Scale
Time Frame: post-operative day 3
|
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. |
post-operative day 3
|
|
Visual-analogue Anxiety Scale
Time Frame: post-operative day 7
|
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. |
post-operative day 7
|
|
Visual-analogue Anxiety Scale
Time Frame: post-operative day 14
|
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. |
post-operative day 14
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthew J Ziegelmann, MD, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Mental Disorders
- Genital Diseases, Male
- Male Urogenital Diseases
- Sexual Dysfunction, Physiological
- Sexual Dysfunctions, Psychological
- Erectile Dysfunction
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Central Nervous System Depressants
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
Other Study ID Numbers
- 20-010842
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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