Randomized Trial of Ropivacaine & Bupivacaine for Inflatable Penile Prosthesis

NCT04801368 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20-010842
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  post-operative day 14

Study Arms (2)

Receiving Ropivacaine

EXPERIMENTAL

Patients receiving Ropivacaine.

Drug: Randomization of two local anesthetics.

Receiving Liposomal Bupivacaine

EXPERIMENTAL

Patients receiving Liposomal Bupivacaine.

Drug: Randomization of two local anesthetics.

Interventions

Randomization of two local anesthetics. DRUG

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

Receiving Liposomal Bupivacaine; Receiving Ropivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men undergoing 3-piece penile prosthesis placement under general anesthesia at Mayo Clinic - Rochester.
• ≥ 18 years old.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Matthew Ziegelmann
• Organization: Mayo Clinic

Ziegelmann.Matthew@mayo.edu

507-266-3982

Study Officials

• Matthew J Ziegelmann, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient is blind to local anesthetic being administered.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 17, 2021
• Study Start: October 1, 2021
• Primary Completion: January 7, 2024
• Study Completion: January 8, 2024
• Last Updated: February 4, 2025
• Results First Posted: February 4, 2025

Record last verified: 2025-01

Locations

US (1)