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NCT02381353 · ClinicalTrials.gov registry record · Phase 4
Exparel Injection for Postoperative Orbital Pain
A Phase 4 study of Pain, Postoperative, sponsored by Mayo Clinic.
- Active
- Registry status
- Phase 4
- Development phase
- 88
- Enrollment target
- 2
- Study locations
NCT02381353: Active Phase 4 study of Pain, Postoperative, sponsored by Mayo Clinic.
NCT02381353 is a Phase 4 study of Pain, Postoperative that is active but no longer recruiting, run by Mayo Clinic. The registered enrollment target is 88 participants, below the 272-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (68% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02381353, a Phase 4 study of Pain, Postoperative, is active but no longer recruiting, sponsored by Mayo Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 88 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Pain on a scale of 0-10, assessed on day 3 post enucleation or evisceration
Conditions Studied
Interventions
- DRUG Bupivacaine
Study Locations (2)
Michigan
- University of Michigan Kellogg Eye Institute - Ann Arbor
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2015-02 |
| Est. Completion | 2026-12 |
| Phase | Phase 4 |
What the registry record for NCT02381353 still lists
NCT02381353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 272-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Pain, Postoperative appearing as the primary indexed condition, and to 1 intervention - of which Bupivacaine is the first listed.
NCT02381353 reports a single indexed study location in Michigan, Minnesota.
Frequently Asked Questions
What is clinical trial NCT02381353 about?
NCT02381353 is a clinical study titled "Exparel Injection for Postoperative Orbital Pain". 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...
What is the current status of trial NCT02381353?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 88 participants. The study started on 2015-02. Estimated completion is 2026-12.
What conditions does trial NCT02381353 study?
This clinical trial studies the following conditions: Pain, Postoperative.
What interventions are being tested in trial NCT02381353?
The interventions under investigation include: Bupivacaine (DRUG).
Who is sponsoring clinical trial NCT02381353?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02381353 being conducted?
This trial has 2 study locations across Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02381353's enrollment target sits among peer trials
88 54th of 113 higher than 60 of 113 other Pain, Postoperative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Postoperative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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