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Pain Control for Undergoing Costal Cartilage Harvesting

Pain Control for Undergoing Costal Cartilage Harvesting

Recruiting
18 years and older
All
Phase 4

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Overview

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

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.

Study details
    Nasal Surgery

NCT05285566

Mayo Clinic

17 June 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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