Pain Control for Undergoing Costal Cartilage Harvesting

Study Overview
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Brief Summary
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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®.

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

Conditions
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Nasal Surgery

Intervention / Treatment
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* Drug: Exparel
* Drug: Xylocaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exparel® Injection Group<br>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® | Drug: Exparel<br>* 106mg (8 mL) subcutaneous injection injected after costal cartilage harvest<br>* Other names: Liposomal bupivacaine;|
| Active Comparator: Xylocaine® Injection Group<br>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. | Drug: Xylocaine<br>* 8 mL of 1% lidocaine with 1:100,000 of epinephrine into costal cartilage wound site<br>* Other names: Lidocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | Measured using a visual analog scale 0=no pain and 10=worst possible | 7-10 days following the last administration of study treatment | 
| Change in oral pain medication | Total oral pain medication usage self-reported in pain medication diary | 7-10 days following the last administration of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Reactions | Total number of adverse reactions reported to the study agent | 7-10 days following the last administration of study treatment |