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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-10 days following the last administration of study treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I need nasal surgery for breathing problems or to improve my nose's appearance, involving cartilage grafting.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in oral pain medication
Pain
Secondary outcome measures
Adverse Reactions
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
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,211 Previous Clinical Trials
3,766,938 Total Patients Enrolled
Michael D Olson, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need nasal surgery for breathing problems or to improve my nose's appearance, involving cartilage grafting.I have a serious lung condition like severe asthma, COPD, or lung scarring.I have a bleeding disorder like hemophilia or Von Willebrand disease.I have a history of heart problems, including past heart attacks or current heart symptoms.I am not taking blood thinners like aspirin, Coumadin, or Plavix.I am able to give my own consent for treatment.I have had liver disease or abnormal liver tests in the last 3 months.My kidney function is impaired with creatinine over 1.2 or GFR under 60.I need nasal surgery for breathing problems or to improve my nose's appearance, involving cartilage grafting.
Research Study Groups:
This trial has the following groups:- Group 1: Exparel® Injection Group
- Group 2: Xylocaine® Injection Group
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Exparel acquired the official sanction of the Food and Drug Administration?
"There is a great deal of evidence backing the safety of Exparel, resulting in it being given a rating of 3. This Phase 4 trial indicates that this treatment has already been granted approval."
Answered by AI
How many individuals are being recruited for this clinical trial?
"Affirmative. Clinicaltrials.gov records the latest information, which suggests that this particular clinical trial is actively recruiting participants from a single site - 60 in total since its initial posting on May 4th 2022 and last update on June 11th 2022."
Answered by AI
Is it still possible to volunteer for this clinical investigation?
"According to the information on clinicaltrials.gov, this research study is in its active recruitment phase and was originally posted on May 4th 2022 before being revised on June 11th of the same year."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Did not meet criteria
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