Exparel Injection for Postoperative Orbital Pain

NCT02381353 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 14-007145
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pain, Postoperative

Keywords

Enucleation; Evisceration; Exparel; bupivacaine

Outcome Measures

Primary Outcomes (1)

• Postoperative orbital pain

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

  Days 3 postoperatively

Secondary Outcomes (4)

• Postoperative nausea and vomiting

  Days 3 postoperatively

• Quantity of oral narcotics used for postoperative pain control

  Days 3 postoperatively

• Patient satisfaction

  Day 3 postoperatively

• Postoperative complications

  6-8 weeks postoperatively

Study Arms (2)

Plain bupivacaine

ACTIVE COMPARATOR

Intraoperative injection of local anesthetic agent, standard of care

Drug: Bupivacaine

Exparel (sustained release bupivacaine)

EXPERIMENTAL

Intraoperative injection of local anesthetic agent, long acting agent

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

Intraoperative orbital injection of local pain medication

Also known as: Exparel

Exparel (sustained release bupivacaine); Plain bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

University of Michigan Kellogg Eye Institute

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Elizabeth Bradley, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: March 6, 2015
• Study Start: February 1, 2015
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From July 2024 through end of reporting period.

Locations

US (2)