Pain, Postoperative
Conditions
Keywords
Enucleation, Evisceration, Exparel, bupivacaine
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.
Interventions
DRUGBupivacaine
Intraoperative orbital injection of local pain medication
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative orbital pain | Days 3 postoperatively | Pain on a scale of 0-10, assessed on day 3 post enucleation or evisceration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed