A Study to Analyze the Effects of Exparel for Post-Surgery Pain Control in Patients Undergoing Penile Prosthesis Placement
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-010842
NCT ID: NCT04801368
About this study
The purpose of this study is to determine the effects of liposomal bupivacaine vs lidocaine/bupivacaine mixture in patients’ undergoing surgical placement of a penile prosthesis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Matthew Ziegelmann, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available