Randomized Trial of Ropivacaine & Bupivacaine for Inflatable Penile Prosthesis

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 20

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Receiving Liposomal Bupivacaine	Randomization of two local anesthetics.	Patients receiving Liposomal Bupivacaine.
Receiving Ropivacaine	Randomization of two local anesthetics.	Patients receiving Ropivacaine.

Primary Outcome Measures

Name	Time	Method
Visual-analogue Pain Scale	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.
Visual-analogue Anxiety Scale	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.