Using Exparel injection to manage postoperative eye pain
Postoperative Pain Control After Enucleation or Evisceration, a Double-Masked Randomized Controlled Trial of Standard Versus Slow-release Bupivacaine
PHASE4 · Mayo Clinic · NCT02381353
This study is testing if an injection called Exparel can help reduce pain after eye removal surgeries for patients compared to regular pain relief options.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT02381353 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Exparel, a liposomal formulation of bupivacaine, in managing postoperative pain following eye removal surgeries such as enucleation and evisceration. The study aims to assess pain levels, opioid usage, and patient satisfaction in individuals receiving Exparel compared to standard bupivacaine injections. Participants will be monitored for pain control over a period of several days post-surgery. The trial is conducted at the Mayo Clinic and the University of Michigan Kellogg Eye Institute.
Who should consider this trial
Good fit: Ideal candidates include adults undergoing enucleation or evisceration of the eye at the participating institutions.
Not a fit: Patients under 18 years old, pregnant, or nursing will not benefit from this study as Exparel has not been tested in these populations.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and opioid consumption for patients undergoing eye removal surgeries.
How similar studies have performed: Previous studies have shown success with Exparel in various surgical settings, indicating potential for effective pain management in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. All patients undergoing enucleation or evisceration of the eye whose surgery is performed by the Department of Ophthalmology at Mayo Clinic Rochester 2. Willing and able to comprehend a numerical rating scale system and provide a score to assess pain, nausea, and satisfaction level. Exclusion criteria: 1. Age less than 18 years (Exparel has not been tested in a pediatric population) 2. Pregnant or nursing (Exparel has not been tested in this patient population)
Where this trial is running
Ann Arbor, Michigan and 1 other locations
- University of Michigan Kellogg Eye Institute — Ann Arbor, Michigan, United States (COMPLETED)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Elizabeth Bradley, MD — Mayo Clinic
- Study coordinator: Elizabeth A Bradley, MD
- Email: bradley.elizabeth@mayo.edu
- Phone: 507-284-3340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain, Postoperative, Enucleation, Evisceration, Exparel, bupivacaine