Pain Control for Undergoing Costal Cartilage Harvesting

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05285566
Collaborator
(none)
60
1
2
23.9
2.5

Study Details

Study Description

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®.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Phase IV Randomized, Single-Blind Trial of Liposomal Bupivacaine (Exparel®) for Pain Control in Costal Cartilage Harvest
Actual Study Start Date :
May 4, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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®

Drug: Exparel
106mg (8 mL) subcutaneous injection injected after costal cartilage harvest
Other Names:
  • Liposomal bupivacaine
  • 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.

    Drug: Xylocaine
    8 mL of 1% lidocaine with 1:100,000 of epinephrine into costal cartilage wound site
    Other Names:
  • Lidocaine
  • Outcome Measures

    Primary Outcome Measures

    1. Pain Scores [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 [7-10 days following the last administration of study treatment]

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

    Secondary Outcome Measures

    1. Adverse Reactions [7-10 days following the last administration of study treatment]

      Total number of adverse reactions reported to the study agent

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Michael D Olson, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Michael D. Olson, M.D., Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05285566
    Other Study ID Numbers:
    • 21-008473
    First Posted:
    Mar 17, 2022
    Last Update Posted:
    Jun 14, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 14, 2022