Pain Control for Undergoing Costal Cartilage Harvesting

Overview

About this study

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. 

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:

  • 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.

 

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

Michael Olson, M.D.

Open for enrollment

Contact information:

Michael Olson M.D.

(507) 284-2453

Olson.Michael@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20530079

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