Exparel Injection for Postoperative Orbital Pain

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02381353
• Other study ID #: 14-007145
• Status: Recruiting
• Phase: Phase 4
• Start date: February 2015
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: Elizabeth A Bradley, MD
• Phone: 507-284-3340
• Email: bradley.elizabeth[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT03003741

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Bupivacaine
Intraoperative orbital injection of local pain medication

Locations

Country	Name	City	State
United States	University of Michigan Kellogg Eye Institute	Ann Arbor	Michigan
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative orbital pain	Pain on a scale of 0-10, assessed on day 3 post enucleation or evisceration	Days 3 postoperatively
Secondary	Postoperative nausea and vomiting	Nausea and vomiting on a scale of 0-3, assessed on day 3 post enucleation or evisceration	Days 3 postoperatively
Secondary	Quantity of oral narcotics used for postoperative pain control	Number of oral narcotic pills taken during postoperative days 0-3	Days 3 postoperatively
Secondary	Patient satisfaction	Overall satisfaction with postoperative recovery, assessed on a scale of 1-5	Day 3 postoperatively
Secondary	Postoperative complications	Assessment of any postsurgical complications completed at postoperative visit	6-8 weeks postoperatively

External Links

•   Mayo Clinic Clinical Trials