NCT05285566 Pain Control for Undergoing Costal Cartilage Harvesting
| NCT ID | NCT05285566 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mayo Clinic |
| Condition | Nasal Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-05-04 |
| Primary Completion | 2026-08-21 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2022-05-04 with a primary completion date of 2026-08-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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®.
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.
Contact & Investigator
Michael D Olson, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT05285566 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nasal Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05285566 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05285566 currently recruiting?
Yes, NCT05285566 is actively recruiting participants. Contact the research team at Tuchscherer.Amy@mayo.edu for enrollment information.
Where is the NCT05285566 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05285566 clinical trial?
NCT05285566 is sponsored by Mayo Clinic. The principal investigator is Michael D Olson, MD at Mayo Clinic. The trial plans to enroll 60 participants.