Exparel Injection for Postoperative Orbital Pain

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Elizabeth Bradley, M.D.

Open for enrollment

Contact information:

Jessica Morgan C.O.A.

(507) 293-9689

Morgan.Jessica@mayo.edu

More information

Publications

Publications are currently not available