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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®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel® Injection Group | Experimental | 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® |
|
| Xylocaine® Injection Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | 106mg (8 mL) subcutaneous injection injected after costal cartilage harvest |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Tuchscherer | Contact | 507-538-6582 | Tuchscherer.Amy@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael D Olson, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Xylocaine | Drug | 8 mL of 1% lidocaine with 1:100,000 of epinephrine into costal cartilage wound site |
|
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| Aniline Compounds |
| D000588 | Amines |