Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02381353

Exparel Injection for Postoperative Orbital Pain

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan Kellogg Eye Institute, Ann Arbor, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bupivacaine

Drug

Intraoperative orbital injection of local pain medication

Other names: Exparel

Primary outcomes

  1. Postoperative orbital pain

    Time frame: Days 3 postoperatively

    Pain on a scale of 0-10, assessed on day 3 post enucleation or evisceration

Secondary outcomes

  1. Postoperative nausea and vomiting

    Time frame: Days 3 postoperatively

    Nausea and vomiting on a scale of 0-3, assessed on day 3 post enucleation or evisceration

  2. Quantity of oral narcotics used for postoperative pain control

    Time frame: Days 3 postoperatively

    Number of oral narcotic pills taken during postoperative days 0-3

  3. Patient satisfaction

    Time frame: Day 3 postoperatively

    Overall satisfaction with postoperative recovery, assessed on a scale of 1-5

  4. Postoperative complications

    Time frame: 6-8 weeks postoperatively

    Assessment of any postsurgical complications completed at postoperative visit

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2015
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.