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Completed

NCT Number: NCT04801368

Randomized Trial of Ropivacaine & Bupivacaine for Inflatable Penile Prosthesis

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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Randomization of two local anesthetics.

Drug

Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Randomized-Controlled Trial Comparing Long-acting and Short-acting Local Anesthetics at the Time of Penile Prosthesis Placement

Acronym: ROVEX-IPP

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 17, 2021
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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