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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plain bupivacaine | Active Comparator | Intraoperative injection of local anesthetic agent, standard of care |
|
| Exparel (sustained release bupivacaine) | Experimental | Intraoperative injection of local anesthetic agent, long acting agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Intraoperative orbital injection of local pain medication |
|
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Bradley, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Kellogg Eye Institute | Ann Arbor | Michigan | 48109 | United States | ||
| Mayo Clinic in Rochester |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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University of Michigan will share patient study data with Mayo site. A Data Use Agreement has been approved for this purpose.
From July 2024 through end of reporting period.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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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 |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |