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

Overview

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Ziegelmann, M.D.

Open for enrollment

Contact information:

Alex Ferguson

(507) 422-5102

Ferguson.Alex@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20514206

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