Pain Control for Undergoing Costal Cartilage Harvesting

Nasal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285566
• Other study ID #: 21-008473
• Status: Recruiting
• Phase: Phase 4
• Start date: May 4, 2022
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: Amy Tuchscherer
• Phone: 507-538-6582
• Email: Tuchscherer.Amy[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Surgery

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Adverse Reactions	Total number of adverse reactions reported to the study agent	7-10 days following the last administration of study treatment