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Local Anesthetic

Exparel Injection for Postoperative Pain

Phase 4
Recruiting
Led By Elizabeth Bradley, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients undergoing enucleation or evisceration of the eye whose surgery is performed by the Department of Ophthalmology at Mayo Clinic Rochester
Be older than 18 years old
Must not have
Age less than 18 years (Exparel has not been tested in a pediatric population)
Pregnant or nursing (Exparel has not been tested in this patient population)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-8 weeks postoperatively
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial will compare the postoperative pain control of Exparel (a bupivacaine liposomal injectable suspension) to that of plain bupivacaine in patients who have had surgery to remove their eye.

Who is the study for?
This trial is for adult patients at Mayo Clinic Rochester undergoing eye removal surgery (enucleation or evisceration) who can understand and use a numerical rating scale to report pain, nausea, and satisfaction. It's not for those under 18 years old or pregnant/nursing individuals.
What is being tested?
The study tests if Exparel, a long-lasting bupivacaine suspension providing up to 72 hours of pain control, is more effective than the standard bupivacaine used during eye socket surgeries in reducing postoperative pain.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with bupivacaine include nausea, vomiting, dizziness, ringing in the ears, numbness of the mouth or tongue, muscle twitches and convulsions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having my eye removed at Mayo Clinic Rochester by the Ophthalmology Department.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am 18 years old or older.
Select...
I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-8 weeks postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-8 weeks postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Postoperative orbital pain
Secondary study objectives
Patient satisfaction
Postoperative complications
Postoperative nausea and vomiting
+1 more

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Exparel (sustained release bupivacaine)Experimental Treatment1 Intervention
Intraoperative injection of local anesthetic agent, long acting agent
Group II: Plain bupivacaineActive Control1 Intervention
Intraoperative injection of local anesthetic agent, standard of care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
2013
Completed Phase 4
~1530

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,873 Total Patients Enrolled
3 Trials studying Postoperative Pain
274 Patients Enrolled for Postoperative Pain
Elizabeth Bradley, MDPrincipal InvestigatorMayo Clinic

Media Library

Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT02381353 — Phase 4
Postoperative Pain Research Study Groups: Plain bupivacaine, Exparel (sustained release bupivacaine)
Postoperative Pain Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT02381353 — Phase 4
Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02381353 — Phase 4
~8 spots leftby Dec 2025
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