Pain Control for Undergoing Costal Cartilage Harvesting

Mayo Clinic

Status and phase: Enrolling; Phase 4

Conditions: Nasal Surgery

Treatments: Drug: Exparel; Drug: Xylocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05285566

21-008473

Details and patient eligibility

About

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®.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Exparel® Injection Group

Experimental group

Description:

On the day of clinically indicated nasal surgery the surgical wound on the chest, where the rib cartilage is removed, will be injected with Exparel®

Treatment:

Drug: Exparel

Xylocaine® Injection Group

Active Comparator group

Description:

On the day of clinically indicated nasal surgery the surgical wound on the chest, where the rib cartilage is removed, will be injected with Xylocaine® as part of standard of care.

Treatment:

Drug: Xylocaine