Pain control during rib cartilage removal for nasal surgery
A Phase IV Randomized, Single-Blind Trial of Liposomal Bupivacaine (Exparel®) for Pain Control in Costal Cartilage Harvest
This study is testing if a new long-lasting numbing medicine can help reduce pain better than the usual numbing shot after people have rib cartilage removed for nasal surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT05285566 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of EXPAREL®, a long-acting numbing medication, in reducing pain following rib cartilage harvesting compared to the standard local anesthetic, XYLOCAINE®. Participants undergoing nasal surgery that requires the removal of costal cartilage will receive one of the two medications to assess pain management outcomes. The study is designed to provide insights into pain control methods in surgical procedures involving rib cartilage.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with functional nasal obstruction or aesthetic concerns requiring nasal surgery that involves rib cartilage harvesting.
Not a fit: Patients with known pregnancy, nursing status, or significant bleeding disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing nasal surgery.
How similar studies have performed: Other studies have shown promising results with long-acting local anesthetics, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Michael D Olson, MD — Mayo Clinic
- Study coordinator: Amy Tuchscherer
- Email: Tuchscherer.Amy@mayo.edu
- Phone: 507-538-6582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.