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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-8 weeks postoperatively
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am having my eye removed at Mayo Clinic Rochester by the Ophthalmology Department.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-8 weeks postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-8 weeks postoperatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative orbital pain
Secondary outcome measures
Patient satisfaction
Postoperative complications
Postoperative nausea and vomiting
+1 moreTrial 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
3,245 Previous Clinical Trials
3,783,382 Total Patients Enrolled
3 Trials studying Postoperative Pain
274 Patients Enrolled for Postoperative Pain
Elizabeth Bradley, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am having my eye removed at Mayo Clinic Rochester by the Ophthalmology Department.I am not pregnant or nursing.
Research Study Groups:
This trial has the following groups:- Group 1: Plain bupivacaine
- Group 2: Exparel (sustained release bupivacaine)
Awards:
This trial has 3 awards, including:- 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.
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.
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