Exparel Injection for Postoperative Orbital Pain

Study Overview
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Brief Summary
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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.

Official Title
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Postoperative Pain Control After Enucleation or Evisceration, a Double-Masked Randomized Controlled Trial of Standard Versus Slow-release Bupivacaine

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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. Exclusion criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plain bupivacaine<br>Intraoperative injection of local anesthetic agent, standard of care | Drug: Bupivacaine<br>* Intraoperative orbital injection of local pain medication<br>* Other names: Exparel;|
| Experimental: Exparel (sustained release bupivacaine)<br>Intraoperative injection of local anesthetic agent, long acting agent | Drug: Bupivacaine<br>* Intraoperative orbital injection of local pain medication<br>* Other names: Exparel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative orbital pain | Pain on a scale of 0-10, assessed on day 3 post enucleation or evisceration | Days 3 postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting | Nausea and vomiting on a scale of 0-3, assessed on day 3 post enucleation or evisceration | Days 3 postoperatively | 
| Quantity of oral narcotics used for postoperative pain control | Number of oral narcotic pills taken during postoperative days 0-3 | Days 3 postoperatively | 
| Patient satisfaction | Overall satisfaction with postoperative recovery, assessed on a scale of 1-5 | Day 3 postoperatively | 
| Postoperative complications | Assessment of any postsurgical complications completed at postoperative visit | 6-8 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enucleation, Evisceration, Exparel, bupivacaine