Pain Control for Undergoing Costal Cartilage Harvesting

Overview

Información sobre este estudio

The purpose of this study is to investigate whether the injection of a long active liposomal bupivacaine product, currently approved for injection into operative sites for post-surgical pain, is an acceptable treatment for costal cartilage harvest site pain when injected into the surgical site after costal cartilage harvest in comparison to the standard treatment of 1% lidocaine with 1:100:000 of epinephrine at the surgical site. 

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:

  • Diagnosis of functional nasal obstruction or aesthetic nasal concern requiring nasal surgery with costal cartilage harvest.
  • Male or female with age ≥ 18 years.
  • Willing and able to understand and provide written informed consent.

Exclusion Criteria:

  • Age < 18 years of age.
  • Known pregnancy.
  • Women who are currently nursing a child.
  • History of coagulopathy; such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder.
  • Use of anticoagulation medication during the study; i.e. aspirin, Coumadin, Plavix, or medications similar in class to these medications will exclude the patient from participation.
  • Inability to provide informed consent (patients under guardianship).
  • Known hypersensitivity to local anesthetics
  • History of cardiac disease; such as current impaired cardiovascular function, past history of myocardial infarction, congenital heart disease, current cardiac symptoms; i.e. angina, shortness of breath, or chest pain as determined by history or review of the medical record.
  • History of complex pulmonary disease; such as uncontrolled asthma, COPD, or interstitial lung disease as determined by history or review of the medical record. 
  • Impaired renal function as documented in the medical record in the last 3 months with a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate < 60 mL/min/BSA as determined by history or review of the medical record.
  • History of or current hepatic disease as documented by liver function test abnormality in the last 3 months as determined by history or review of the medical record. 

Eligibility last updated 8/16/21. Questions regarding updates should be directed to the study team contact.

 

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 Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Michael Olson, M.D.

Abierto para la inscripción

Contact information:

Michael Olson M.D.

(507) 284-2453

Olson.Michael@mayo.edu

More information

Publicaciones

Publications are currently not available
.
CLS-20530079

Mayo Clinic Footer