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Active, not recruiting Phase 4 Interventional

Exparel Injection for Postoperative Orbital Pain

ClinicalTrials.gov ID: NCT02381353

Public ClinicalTrials.gov record NCT02381353. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 31, 2026, 6:12 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02381353
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 4
Lead sponsor
Mayo Clinic
Other
Enrollment
88 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2015
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026
Last update posted
Jan 11, 2026

2015 – 2026

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
University of Michigan Kellogg Eye Institute Ann Arbor Michigan 48109
Mayo Clinic in Rochester Rochester Minnesota 55905

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Recently updated Pain, Postoperative trials

Other public records listing Pain, Postoperative. Sorted by last update posted; newest first. Not a recommendation.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02381353, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 11, 2026 · Synced Jul 31, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02381353 live on ClinicalTrials.gov.

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