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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

 

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Matthew Ziegelmann, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20514206

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