A Study to Analyze the Effects of Exparel for Post-Surgery Pain Control in Patients Undergoing Penile Prosthesis Placement
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Receiving Ropivacaine Patients receiving Ropivacaine. |
Procedure: Randomization of two local anesthetics.
Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
| Experimental: Receiving Liposomal Bupivacaine Patients receiving Liposomal Bupivacaine. |
Procedure: Randomization of two local anesthetics.
Patients will be blinded and randomized to two different arms. One receiving ropivacaine, one receiving liposomal bupivacaine.
|
Outcome Measures
Primary Outcome Measures
- Visual-analogue pain scale [post-operative day 1]
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.
- Visual-analogue pain scale [post-operative day 3]
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.
- Visual-analogue pain scale [post-operative day 7]
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.
- Visual-analogue pain scale [post-operative day 14]
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.
- Visual-analogue anxiety scale [post-operative day 1]
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.
- Visual-analogue anxiety scale [post-operative day 3]
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.
- Visual-analogue anxiety scale [post-operative day 7]
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.
- Visual-analogue anxiety scale [post-operative day 14]
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.
- State Trait Anxiety Inventory [post-operative day 1]
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.
- State Trait Anxiety Inventory [post-operative day 3]
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.
- State Trait Anxiety Inventory [post-operative day 7]
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.
- State Trait Anxiety Inventory [post-operative day 14]
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.
- Pain Catastrophizing scale [post-operative day 1]
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.
- Pain Catastrophizing scale [post-operative day 3]
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.
- Pain Catastrophizing scale [post-operative day 7]
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.
- Pain Catastrophizing scale [post-operative day 14]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Matthew J Ziegelmann, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20-010842