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Local Anesthetic

Pain Control with Exparel and Xylocaine for Rhinoplasty

Phase 4

Recruiting

Led By Michael D Olson, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of functional nasal obstruction or aesthetic nasal concern requiring nasal surgery with costal cartilage harvest

Be older than 18 years old

Must not have

History of complex pulmonary disease such as uncontrolled asthma, COPD, or interstitial lung disease as determined by history or review of the medical record

History of coagulopathy such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7-10 days following the last administration of study treatment

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will compare the effects of two different drugs for pain relief after rib cartilage removal.

Who is the study for?

This trial is for individuals needing nasal surgery with rib cartilage removal who can consent to the study. It's not for nursing women, those with bleeding disorders or on blood thinners, heart or severe lung disease, kidney or liver issues, pregnant women, or anyone allergic to local anesthetics.

What is being tested?

The study aims to compare pain control after rib cartilage removal using EXPAREL®, a long-acting numbing medication lasting about 96 hours, against the standard XYLOCAINE® injection.

What are the potential side effects?

Possible side effects may include reactions at the injection site such as swelling and redness, potential numbness beyond the desired area due to nerve blockage from EXPAREL®, and typical local anesthetic side effects like light-headedness and dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need nasal surgery for breathing problems or to improve my nose's appearance, involving cartilage grafting.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious lung condition like severe asthma, COPD, or lung scarring.

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I have a bleeding disorder like hemophilia or Von Willebrand disease.

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I have a history of heart problems, including past heart attacks or current heart symptoms.

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I am not taking blood thinners like aspirin, Coumadin, or Plavix.

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I am able to give my own consent for treatment.

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I have had liver disease or abnormal liver tests in the last 3 months.

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My kidney function is impaired with creatinine over 1.2 or GFR under 60.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7-10 days following the last administration of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7-10 days following the last administration of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-10 days following the last administration of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in oral pain medication

Pain

Secondary study objectives

Adverse Reactions

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exparel® Injection GroupExperimental Treatment1 Intervention

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®

Group II: Xylocaine® Injection GroupActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exparel

2014

Completed Phase 4

~1620

0 / 8Eligibility criteria met