Bupivacaine
DrugIntraoperative orbital injection of local pain medication
Other names: Exparel
NCT Number: NCT02381353
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 4
University of Michigan Kellogg Eye Institute, Ann Arbor, Michigan, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intraoperative orbital injection of local pain medication
Other names: Exparel
Time frame: Days 3 postoperatively
Pain on a scale of 0-10, assessed on day 3 post enucleation or evisceration
Time frame: Days 3 postoperatively
Nausea and vomiting on a scale of 0-3, assessed on day 3 post enucleation or evisceration
Time frame: Days 3 postoperatively
Number of oral narcotic pills taken during postoperative days 0-3
Time frame: Day 3 postoperatively
Overall satisfaction with postoperative recovery, assessed on a scale of 1-5
Time frame: 6-8 weeks postoperatively
Assessment of any postsurgical complications completed at postoperative visit
Mayo Clinic
Other
Postoperative Pain Control After Enucleation or Evisceration, a Double-Masked Randomized Controlled Trial of Standard Versus Slow-release Bupivacaine
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