Nasal Surgery
Conditions
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 pain after rib cartilage removal in comparison to the standard injection of XYLOCAINE®.
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
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | 7-10 days following the last administration of study treatment | Measured using a visual analog scale 0=no pain and 10=worst possible |
| Change in oral pain medication | 7-10 days following the last administration of study treatment | Total oral pain medication usage self-reported in pain medication diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Reactions | 7-10 days following the last administration of study treatment | Total number of adverse reactions reported to the study agent |
Countries
United States
Contacts
CONTACTAmy Tuchscherer
PRINCIPAL_INVESTIGATORMichael D Olson, MD
Mayo Clinic
Outcome results
None listed