Pain Control for Undergoing Costal Cartilage Harvesting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exparel, Xylocaine.
- Who it may be relevant to
- Registry conditions: Nasal Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase IV Randomized, Single-Blind Trial of Liposomal Bupivacaine (Exparel®) for Pain Control in Costal Cartilage Harvest
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®.
Interventions
- Drug Exparel
106mg (8 mL) subcutaneous injection injected after costal cartilage harvest - Drug Xylocaine
8 mL of 1% lidocaine with 1:100,000 of epinephrine into costal cartilage wound site
Primary outcome measures
- Pain Scores [Time frame: 7-10 days following the last administration of study treatment]
- Change in oral pain medication [Time frame: 7-10 days following the last administration of study treatment]
Secondary outcome measures (1)
- Adverse Reactions [Time frame: 7-10 days following the last administration of study treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT05285566 · 21-008473