A Study to Analyze the Effects of Exparel for Post-Surgery Pain Control in Patients Undergoing Penile Prosthesis Placement

Study Overview
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Brief Summary
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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.

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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: Randomization of two local anesthetics.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men undergoing 3-piece penile prosthesis placement under general anesthesia at Mayo Clinic - Rochester. ≥ 18 years old. Exclusion Citeria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The two anesthetics being used in the study are FDA approved and used in standard practice for the procedure.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receiving Ropivacaine<br>Patients receiving Ropivacaine. | Drug: Randomization of two local anesthetics.<br>* Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.<br>|
| Experimental: Receiving Liposomal Bupivacaine<br>Patients receiving Liposomal Bupivacaine. | Drug: Randomization of two local anesthetics.<br>* Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual-analogue pain scale | Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no pain, 10 being the most pain. 0 being the best outcome, 10 being the worst outcome. | post-operative day 1 | 
| Visual-analogue pain scale | Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no pain, 10 being the most pain. 0 being the best outcome, 10 being the worst outcome. | post-operative day 3 | 
| Visual-analogue pain scale | Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no pain, 10 being the most pain. 0 being the best outcome, 10 being the worst outcome. | post-operative day 7 | 
| Visual-analogue pain scale | Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no pain, 10 being the most pain. 0 being the best outcome, 10 being the worst outcome. | post-operative day 14 | 
| Visual-analogue anxiety scale | Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no anxiety, 10 being the most anxiety. 0 being the best outcome, 10 being the worst outcome. | post-operative day 1 | 
| Visual-analogue anxiety scale | Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no anxiety, 10 being the most anxiety. 0 being the best outcome, 10 being the worst outcome. | post-operative day 3 | 
| Visual-analogue anxiety scale | Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no anxiety, 10 being the most anxiety. 0 being the best outcome, 10 being the worst outcome. | post-operative day 7 | 
| Visual-analogue anxiety scale | Patients will answer this questionnaire at 4 separate time points. Scale of 1-10, 0 being no anxiety, 10 being the most anxiety. 0 being the best outcome, 10 being the worst outcome. | post-operative day 14 | 
| State Trait Anxiety Inventory | Patients will answer this questionnaire at 4 separate time points. Scale of 1-4 answering 20 questions. 1 being not at all, 2 being a little, 3 being somewhat, 4 being very much so. Best outcome varies with each question. | post-operative day 1 | 
| State Trait Anxiety Inventory | Patients will answer this questionnaire at 4 separate time points. Scale of 1-4 answering 20 questions. 1 being not at all, 2 being a little, 3 being somewhat, 4 being very much so. Best outcome varies with each question. | post-operative day 3 | 
| State Trait Anxiety Inventory | Patients will answer this questionnaire at 4 separate time points. Scale of 1-4 answering 20 questions. 1 being not at all, 2 being a little, 3 being somewhat, 4 being very much so. Best outcome varies with each question. | post-operative day 7 | 
| State Trait Anxiety Inventory | Patients will answer this questionnaire at 4 separate time points. Scale of 1-4 answering 20 questions. 1 being not at all, 2 being a little, 3 being somewhat, 4 being very much so. Best outcome varies with each question. | post-operative day 14 | 
| Pain Catastrophizing scale | Patients will answer this questionnaire at 4 separate time points. Scale of 0-4 answering 20 questions. 0 being not at all, 1 being to a slight degree, 2 being to a moderate degree, 3 being to a great degree, 4 being all the time. Best outcome varies with each question. | post-operative day 1 | 
| Pain Catastrophizing scale | Patients will answer this questionnaire at 4 separate time points. Scale of 0-4 answering 20 questions. 0 being not at all, 1 being to a slight degree, 2 being to a moderate degree, 3 being to a great degree, 4 being all the time. Best outcome varies with each question. | post-operative day 3 | 
| Pain Catastrophizing scale | Patients will answer this questionnaire at 4 separate time points. Scale of 0-4 answering 20 questions. 0 being not at all, 1 being to a slight degree, 2 being to a moderate degree, 3 being to a great degree, 4 being all the time. Best outcome varies with each question. | post-operative day 7 | 
| Pain Catastrophizing scale | Patients will answer this questionnaire at 4 separate time points. Scale of 0-4 answering 20 questions. 0 being not at all, 1 being to a slight degree, 2 being to a moderate degree, 3 being to a great degree, 4 being all the time. Best outcome varies with each question. | post-operative day 14 |