Pain Control for Undergoing Costal Cartilage Harvesting

NCT05285566 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 21-008473
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Pain Scores

  Measured using a visual analog scale 0=no pain and 10=worst possible

  7-10 days following the last administration of study treatment

• Change in oral pain medication

  Total oral pain medication usage self-reported in pain medication diary

  7-10 days following the last administration of study treatment

Secondary Outcomes (1)

• Adverse Reactions

  7-10 days following the last administration of study treatment

Study Arms (2)

Exparel® Injection Group

EXPERIMENTAL

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®

Drug: Exparel

Xylocaine® Injection Group

ACTIVE COMPARATOR

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.

Drug: Xylocaine

Interventions

Exparel DRUG

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

Also known as: Liposomal bupivacaine

Exparel® Injection Group

Xylocaine DRUG

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

Also known as: Lidocaine

Xylocaine® Injection Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Michael D Olson, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Tuchscherer

CONTACT

507-538-6582; Tuchscherer.Amy@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: May 4, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

US (1)