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

Who is this study for? Patients undergoing enucleation or evisceration of the eye
What treatments are being studied? Bupivacaine
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Michigan
University of Michigan Kellogg Eye Institute
COMPLETED
Ann Arbor
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Elizabeth A Bradley, MD
bradley.elizabeth@mayo.edu
507-284-3340
Time Frame
Start Date: 2015-02
Estimated Completion Date: 2026-12
Participants
Target number of participants: 88
Treatments
Active_comparator: Plain bupivacaine
Intraoperative injection of local anesthetic agent, standard of care
Experimental: Exparel (sustained release bupivacaine)
Intraoperative injection of local anesthetic agent, long acting agent
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov