Pain, PostoperativePhase 4NCT02381353
Exparel Injection for Postoperative Orbital Pain
A Phase 4 study testing Bupivacaine in people with Pain, Postoperative, run by Mayo Clinic at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2015to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Kellogg Eye Institute
Ann Arbor, Michigan, 48109
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Postoperative Pain Control After Enucleation or Evisceration, a Double-Masked Randomized Controlled Trial of Standard Versus Slow-release Bupivacaine
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
- Being tested
- Bupivacaine
- Keywords
- Enucleation, Evisceration, Exparel, bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Exparel
Intraoperative orbital injection of local pain medication
| Study group | Role | What they receive |
|---|---|---|
| Plain bupivacaine | Active comparator | Intraoperative injection of local anesthetic agent, standard of care Receives: Drug: Bupivacaine |
| Exparel (sustained release bupivacaine) | Experimental | Intraoperative injection of local anesthetic agent, long acting agent Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative orbital pain
Pain on a scale of 0-10, assessed on day 3 post enucleation or evisceration
Measured: Days 3 postoperatively
Secondary outcomes (4)
Postoperative nausea and vomiting
Nausea and vomiting on a scale of 0-3, assessed on day 3 post enucleation or evisceration
Measured: Days 3 postoperatively
Quantity of oral narcotics used for postoperative pain control
Number of oral narcotic pills taken during postoperative days 0-3
Measured: Days 3 postoperatively
Patient satisfaction
Overall satisfaction with postoperative recovery, assessed on a scale of 1-5
Measured: Day 3 postoperatively
Postoperative complications
Assessment of any postsurgical complications completed at postoperative visit
Measured: 6-8 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth A. Bradley, M.D., Mayo Clinic
- Investigators
- Elizabeth Bradley, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381353
- Sponsor's protocol ID
- 14-007145
- Status last verified
- Jan 2026
- First submitted
- 11 Feb 2015
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: University of Michigan will share patient study data with Mayo site. A Data Use Agreement has been approved for this purpose.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Control After Enucleation or Evisceration, a Double-Masked Randomized Controlled Trial of Standard Versus Slow-release Bupivacaine
- ClinicalTrials.gov ID
- NCT02381353
- Acronym / sponsor ID
- 14-007145
- Conditions
- Pain, Postoperative
- Keywords
- Enucleation, Evisceration, Exparel, bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plain bupivacaine | Active comparator | Drug: BupivacaineIntraoperative injection of local anesthetic agent, standard of care |
| Exparel (sustained release bupivacaine) | Experimental | Drug: BupivacaineIntraoperative injection of local anesthetic agent, long acting agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacaineAlso: ExparelIntraoperative orbital injection of local pain medication | Drug | Exparel (sustained release bupivacaine), Plain bupivacaine |
Primary outcome
Postoperative orbital pain
Time frame: Days 3 postoperatively
Pain on a scale of 0-10, assessed on day 3 post enucleation or evisceration
4 secondary outcomes
Postoperative nausea and vomiting
Time frame: Days 3 postoperatively
Quantity of oral narcotics used for postoperative pain control
Time frame: Days 3 postoperatively
Patient satisfaction
Time frame: Day 3 postoperatively
Postoperative complications
Time frame: 6-8 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. University of Michigan will share patient study data with Mayo site. A Data Use Agreement has been approved for this purpose.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Bradley, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine in people with Pain, Postoperative, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative orbital pain (time frame: Days 3 postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.