Exparel Injection for Postoperative Orbital Pain
Running, not enrolling · Phase 4
Conditions studied: Pain, Postoperative
In brief
After surgery to remove the eye, either by enucleation or evisceration, patients have variable levels of pain for several postoperative days. Some patients have almost no discomfort while others require significant amounts of oral narcotics and report pain of 10 out of 10 on a numerical rating scale. The current operative standard is to infiltrate the eye socket with 0.5% bupivacaine during surgery leading to several hours of postoperative analgesia. In 2011, Pacira Pharmaceuticals released a bupivacaine liposomal injectable suspension (Exparel, 1.3%) which offers sustained release of bupivacaine giving postoperative pain control for up to 72 hours. This medication has been used in numerous surgeries including inguinal hernia repair, hemorrhoidectomy, bunionectomy, breast reconstruction, and orthopedic surgery, and the literature reports improved pain control, decreased use of oral opioids, and increased patient satisfaction. There are no reports of the use of Exparel in the ophthalmic literature. The investigators propose a randomized, controlled trial to compare the postoperative pain control offered by sustained release bupivacaine to that offered by standard plain bupivacaine after enucleation or evisceration.
Key facts
- Study ID
- NCT02381353
- Run by
- Mayo Clinic
- People needed
- 88
- Starts
- 2015-02-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-01-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients undergoing enucleation or evisceration of the eye whose surgery is performed by the Department of Ophthalmology at Mayo Clinic Rochester
- Willing and able to comprehend a numerical rating scale system and provide a score to assess pain, nausea, and satisfaction level.
You may not qualify if…
- 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)
Where it is running
- University of Michigan Kellogg Eye Institute — Ann Arbor, Michigan, United States
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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