Pain Control for Undergoing Costal Cartilage Harvesting

NCT ID: NCT05285566

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-04
• Study Completion Date: 2026-09-30

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®.

Conditions

Nasal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exparel® Injection Group

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®

Group Type: EXPERIMENTAL

Exparel

Intervention Type: DRUG

106mg (8 mL) subcutaneous injection injected after costal cartilage harvest

Xylocaine® Injection Group

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.

Group Type: ACTIVE_COMPARATOR

Xylocaine

Intervention Type: DRUG

8 mL of 1% lidocaine with 1:100,000 of epinephrine into costal cartilage wound site

Interventions

Exparel

106mg (8 mL) subcutaneous injection injected after costal cartilage harvest

Intervention Type: DRUG

Xylocaine

8 mL of 1% lidocaine with 1:100,000 of epinephrine into costal cartilage wound site

Intervention Type: DRUG

Other Intervention Names

Liposomal bupivacaine; Lidocaine

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Michael D. Olson, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael D Olson, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amy Tuchscherer

Role: CONTACT

Tuchscherer.Amy@mayo.edu

507-538-6582

Facility Contacts

Dan Osland

Role: primary

osland.daniel@mayo.edu

Other Identifiers

21-008473

Identifier Type: -

Identifier Source: org_study_id