ACTIVE_NOT_RECRUITING

Exparel Injection for Postoperative Orbital Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2015-02
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT02381353

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. All patients undergoing enucleation or evisceration of the eye whose surgery is performed by the Department of Ophthalmology at Mayo Clinic Rochester
  2. 2. Willing and able to comprehend a numerical rating scale system and provide a score to assess pain, nausea, and satisfaction level.
  1. 1. Age less than 18 years (Exparel has not been tested in a pediatric population)
  2. 2. Pregnant or nursing (Exparel has not been tested in this patient population)

Contacts and Locations

Principal Investigator

Elizabeth Bradley, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

University of Michigan Kellogg Eye Institute
Ann Arbor, Michigan, 48109
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Elizabeth Bradley, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-02
Study Completion Date2026-12

Study Record Updates

Study Start Date2015-02
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Enucleation
  • Evisceration
  • Exparel
  • bupivacaine

Additional Relevant MeSH Terms

  • Pain, Postoperative