Clinical trial NCT02381353: Exparel Injection for Postoperative Orbital Pain
Official title: Postoperative Pain Control After Enucleation or Evisceration, a Double-Masked Randomized Controlled Trial of Standard Versus Slow-release Bupivacaine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Enucleation
Evisceration
Exparel
bupivacaine
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Postoperative orbital pain
timeFrame: Days 3 postoperatively
Secondary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: Days 3 postoperatively
measure: Quantity of oral narcotics used for postoperative pain control
timeFrame: Days 3 postoperatively
measure: Patient satisfaction
timeFrame: Day 3 postoperatively
measure: Postoperative complications
timeFrame: 6-8 weeks postoperatively
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Kellogg Eye Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Elizabeth Bradley, MD
role: PRINCIPAL_INVESTIGATOR
References: