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

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Erectile Dysfunction

Treatments: Drug: Randomization of two local anesthetics.

Study type: Interventional

Funder types: Other

Identifiers

NCT04801368

20-010842

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Receiving Ropivacaine

Experimental group

Description:

Patients receiving Ropivacaine.

Treatment:

Drug: Randomization of two local anesthetics.

Receiving Liposomal Bupivacaine

Experimental group

Description:

Patients receiving Liposomal Bupivacaine.

Treatment:

Drug: Randomization of two local anesthetics.