Randomized Trial of Ropivacaine & Bupivacaine for Inflatable Penile Prosthesis

NCT ID: NCT04801368

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-01-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Receiving Ropivacaine

Patients receiving Ropivacaine.

Group Type: EXPERIMENTAL

Randomization of two local anesthetics.

Intervention Type: DRUG

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

Receiving Liposomal Bupivacaine

Patients receiving Liposomal Bupivacaine.

Group Type: EXPERIMENTAL

Randomization of two local anesthetics.

Intervention Type: DRUG

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

Interventions

Randomization of two local anesthetics.

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Matthew (Matt) J. Ziegelmann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew J Ziegelmann, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-010842

Identifier Type: -

Identifier Source: org_study_id