Actively Recruiting
A Phase IV Randomized, Single-Blind Trial of Liposomal Bupivacaine (Exparel4) for Pain Control in Costal Cartilage Harvest
Led by Mayo Clinic · Updated on 2025-09-12
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether injecting Exparel4, a long-lasting numbing medication approved by the FDA, can reduce pain after rib cartilage removal compared to the standard numbing injection, Xylocaine4. This phase IV clinical trial focuses on patients undergoing nasal surgery that requires rib cartilage harvesting, aiming to improve pain control after the procedure. Participants will be randomly assigned to receive either Exparel4 or Xylocaine4 injected into the chest wound site on the day of their nasal surgery. Exparel4 will be given as a 106 mg (8 mL) subcutaneous injection, while Xylocaine4 will be administered as 8 mL of 1% lidocaine with epinephrine at a concentration of 1:100,000. The study follows a single-blind design, meaning participants will not know which injection they receive. During and after the treatment, participants will be monitored for pain levels and use of oral pain medications for 7 to 10 days following the injection. Researchers will also observe any adverse reactions during this period. The study includes assessments such as pain scoring and medication usage tracking to evaluate the effectiveness and safety of the injections. Total study duration and additional follow-up details are guided by these 7-10 day post-treatment assessments.
CONDITIONS
Brief Title
Pain Control for Undergoing Costal Cartilage Harvesting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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, including aspirin, Coumadin, Plavix, or similar medications
- Inability to provide informed consent (patients under guardianship)
- Known hypersensitivity to local anesthetics
- History of cardiac disease, including impaired cardiovascular function, past myocardial infarction, congenital heart disease, or current cardiac symptoms such as angina or chest pain
- History of complex pulmonary disease, such as uncontrolled asthma, COPD, or interstitial lung disease
- Impaired renal function with serum creatinine greater than 1.2 mg/dL or glomerular filtration rate less than 60 mL/min/BSA
- History of or current hepatic disease as documented by liver function test abnormality in the last 3 months as determined by medical record review
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo nasal surgery involving costal cartilage harvest and receive an injection of either Exparel® or Xylocaine® in the surgical wound on the chest for pain control.
1 surgical visit (in-person)
Duration - 7 to 10 days after surgery
Participants are monitored for pain scores, pain medication use, and adverse reactions following the surgery and injection.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
A
Amy Tuchscherer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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