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Recruiting

NCT Number: NCT05285566

Pain Control for Undergoing Costal Cartilage Harvesting

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®.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Dan Osland

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exparel

Drug

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

Other names: Liposomal bupivacaine

Xylocaine

Drug

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

Other names: Lidocaine

Primary outcomes

  1. Pain Scores

    Time frame: 7-10 days following the last administration of study treatment

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

  2. Change in oral pain medication

    Time frame: 7-10 days following the last administration of study treatment

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

Secondary outcomes

  1. Adverse Reactions

    Time frame: 7-10 days following the last administration of study treatment

    Total number of adverse reactions reported to the study agent

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Tuchscherer

CONTACT

[email protected]

507-538-6582

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Phase IV Randomized, Single-Blind Trial of Liposomal Bupivacaine (Exparel®) for Pain Control in Costal Cartilage Harvest

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2022
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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