Status:
RECRUITING
Pain Control for Undergoing Costal Cartilage Harvesting
Lead Sponsor:
Mayo Clinic
Conditions:
Nasal Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05285566
Start Date
May 4 2022
End Date
September 1 2026
Last Update
September 12 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905