Exparel Injection for Postoperative Orbital Pain
- Registration Number
- NCT02381353
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 88
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Plain bupivacaine Bupivacaine Intraoperative injection of local anesthetic agent, standard of care Exparel (sustained release bupivacaine) Bupivacaine Intraoperative injection of local anesthetic agent, long acting agent
- Primary Outcome Measures
Name Time Method Postoperative orbital pain Days 3 postoperatively Pain on a scale of 0-10, assessed on day 3 post enucleation or evisceration
- Secondary Outcome Measures
Name Time Method Postoperative nausea and vomiting Days 3 postoperatively Nausea and vomiting on a scale of 0-3, assessed on day 3 post enucleation or evisceration
Quantity of oral narcotics used for postoperative pain control Days 3 postoperatively Number of oral narcotic pills taken during postoperative days 0-3
Patient satisfaction Day 3 postoperatively Overall satisfaction with postoperative recovery, assessed on a scale of 1-5
Postoperative complications 6-8 weeks postoperatively Assessment of any postsurgical complications completed at postoperative visit
Trial Locations
- Locations (2)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
University of Michigan Kellogg Eye Institute
🇺🇸Ann Arbor, Michigan, United States