RecruitingPhase 4NCT05285566

Pain Control for Undergoing Costal Cartilage Harvesting

A Phase IV Randomized, Single-Blind Trial of Liposomal Bupivacaine (Exparel®) for Pain Control in Costal Cartilage Harvest


Sponsor

Mayo Clinic

Enrollment

60 participants

Start Date

May 4, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to find out whether injecting the U.S. Food and Drug Administration (FDA) approved drug EXPAREL®, a long acting (approximately 96 hours) numbing medication, will reduce pain after rib cartilage removal in comparison to the standard injection of XYLOCAINE®.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria10

  • 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.

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Interventions

DRUGExparel

106mg (8 mL) subcutaneous injection injected after costal cartilage harvest

DRUGXylocaine

8 mL of 1% lidocaine with 1:100,000 of epinephrine into costal cartilage wound site


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT05285566


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