Randomized Trial of Ropivacaine & Bupivacaine for Inflatable Penile Prosthesis (ROVEX-IPP)

January 14, 2025 updated by: Matthew (Matt) J. Ziegelmann, Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: Randomization of two local anesthetics.
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.
Drug: Randomization of two local anesthetics.
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

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Matthew J Ziegelmann, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

January 7, 2024

Study Completion (Actual)

January 8, 2024

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-010842

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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