Pain Control for Undergoing Costal Cartilage Harvesting

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05285566
Phase
PHASE4
Status
Recruiting

Conditions

  • Nasal Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Exparel — DRUG
    106mg (8 mL) subcutaneous injection injected after costal cartilage harvest
  • Xylocaine — DRUG
    8 mL of 1% lidocaine with 1:100,000 of epinephrine into costal cartilage wound site

Study Details

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®.

Key Dates

Start date
May 4, 2022
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Pain Scores [ Time Frame: 7-10 days following the last administration of study treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905

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