Recruiting

Pain Control

Sponsor:

Mayo Clinic

Code:

NCT05285566

Conditions

Nasal Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Exparel

Xylocaine

Study Details

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 ID

NCT05285566

Start date

May 4, 2022

Status verified date

Sep, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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®

active comparator: 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.

Interventions

Exparel

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

Xylocaine

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

Primary outcome measure

  • Pain Scores [ Time Frame: 7-10 days following the last administration of study treatment ]
  • Change in oral pain medication [ Time Frame: 7-10 days following the last administration of study treatment ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-09-12.