Exparel Injection for Postoperative Orbital Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/8/2019 |
| Start Date: | February 2015 |
| End Date: | December 2020 |
| Contact: | Elizabeth A Bradley, MD |
| Email: | bradley.elizabeth@mayo.edu |
| Phone: | 507-284-3340 |
Postoperative Pain Control After Enucleation or Evisceration, a Double-Masked Randomized Controlled Trial of Standard Versus Slow-release Bupivacaine
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.
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.
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)
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