Exparel Injection for Postoperative Pain

Overseen By Elizabeth A Bradley, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Disqualifiers: Under 18, Pregnant, Nursing

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Immediate postoperative period

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to reduce pain after eye surgery. It examines whether Exparel, a long-acting pain relief injection, can manage pain more effectively than the standard treatment, which lasts only a few hours. The trial focuses on individuals who have had their eye removed or its contents taken out at the Mayo Clinic and can rate their pain using a simple scale. By comparing the two treatments, researchers aim to determine if Exparel provides longer-lasting relief and reduces the need for oral pain medications. Individuals undergoing such eye surgery who can track their pain levels might find this trial suitable. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand how Exparel benefits more patients, offering participants a chance to contribute to broader pain management improvements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Exparel?

Research has shown that Exparel, a long-lasting form of the pain reliever bupivacaine, is generally safe for people. It has been used safely in various surgeries, such as hernia repairs and bone surgeries. Although about 21–30% of patients may still experience moderate to severe pain after surgery, Exparel reduces the need for additional pain medication.

The FDA has approved Exparel for pain control in other surgeries, indicating its safety for people. It is important to consult a healthcare provider for personal advice, especially when considering participation in a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Exparel, a sustained-release form of bupivacaine, stands out because it offers extended pain relief after surgery with just one injection. Unlike the standard bupivacaine, which requires frequent administration to manage pain, Exparel's long-acting formulation provides prolonged pain control, potentially reducing the need for additional pain medications. This is particularly exciting for researchers as it could lead to better pain management and enhanced recovery for patients undergoing surgery.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

This trial will compare Exparel, a long-lasting form of the pain reliever bupivacaine, with plain bupivacaine for postoperative pain management. Studies have shown that Exparel provides better pain control and reduces the need for oral pain medications after surgeries like hernia repair and bunion removal. Research indicates that patients using Exparel feel less pain 24 to 72 hours after surgery compared to those using regular bupivacaine. However, some studies have not found a significant difference in pain relief between Exparel and regular bupivacaine. Despite these mixed results, Exparel is widely used in various surgeries and often leads to higher patient satisfaction due to its longer-lasting pain relief. Overall, Exparel might reduce the need for additional pain medications after surgery. ^{2 5 6 7 8}

Who Is on the Research Team?

Elizabeth Bradley, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adult patients at Mayo Clinic Rochester undergoing eye removal surgery (enucleation or evisceration) who can understand and use a numerical rating scale to report pain, nausea, and satisfaction. It's not for those under 18 years old or pregnant/nursing individuals.

Inclusion Criteria

I am having my eye removed at Mayo Clinic Rochester by the Ophthalmology Department.

Willing and able to comprehend a numerical rating scale system and provide a score to assess pain, nausea, and satisfaction level.

Exclusion Criteria

I am not pregnant or nursing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Intraoperative injection of local anesthetic agent, either standard plain bupivacaine or sustained release bupivacaine (Exparel)

Immediate postoperative period

1 visit (in-person, during surgery)

Postoperative Monitoring

Assessment of postoperative pain, nausea, vomiting, and patient satisfaction on day 3 post-surgery

3 days

1 visit (in-person or virtual)

Follow-up

Participants are monitored for postoperative complications and overall recovery

6-8 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine

Trial Overview

The study tests if Exparel, a long-lasting bupivacaine suspension providing up to 72 hours of pain control, is more effective than the standard bupivacaine used during eye socket surgeries in reducing postoperative pain.

How Is the Trial Designed?

Group I: Exparel (sustained release bupivacaine) Experimental Treatment 1 Intervention

Intraoperative injection of local anesthetic agent, long acting agent

Group II: Plain bupivacaine Active Control 1 Intervention

Intraoperative injection of local anesthetic agent, standard of care

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in European Union as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

EXPAREL® (bupivacaine liposome injectable suspension) is an FDA-approved extended-release anesthetic that significantly reduces postoperative pain and opioid consumption in patients undergoing total knee and hip replacement surgeries, as shown in multiple phase 2 and phase 3 studies.

Using EXPAREL® as part of a multimodal pain management approach leads to better outcomes, including lower pain scores, reduced need for rescue opioids, and improved patient satisfaction during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in incorporation of local analgesics in postsurgical pain pathways. Lombardi, AV.[2014]

In a study involving 100 patients with pulpal necrosis, liposomal bupivacaine did not show a statistically significant improvement in postoperative pain relief compared to standard bupivacaine, with success rates of 29% and 22% respectively.

While liposomal bupivacaine had some effects on soft tissue numbness and non-narcotic medication use, these effects were not clinically significant, indicating that it may not provide additional benefits over traditional bupivacaine for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Liposomal Bupivacaine (Exparel) Significantly Reduce Postoperative Pain/Numbness in Symptomatic Teeth with a Diagnosis of Necrosis? A Prospective, Randomized, Double-blind Trial. Glenn, B., Drum, M., Reader, A., et al.[2017]

In a study involving 98 mice, liposomal bupivacaine (Exparel®) provided a longer duration of pain relief compared to standard bupivacaine, with motor block lasting up to 180 minutes and thermoalgesic block lasting up to 420 minutes.

The addition of dexamethasone, either perineurally or systemically, significantly reduced neural inflammation caused by bupivacaine, and perineural dexamethasone also helped reduce inflammation from Exparel®, suggesting a protective effect against nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. Ferré, F., Krin, A., Sanchez, M., et al.[2020]

EXPAREL® (bupivacaine liposome injectable suspension) is an effective extended-release local anesthetic that can significantly improve postoperative pain management in orthopedic trauma surgery, as demonstrated in two case studies.

Both patients treated with EXPAREL® experienced good control of postsurgical pain, highlighting its safety and efficacy as part of a multimodal analgesia approach in reducing the risk of chronic pain after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local infiltration of liposome bupivacaine in orthopedic trauma patients: case-based reviews. Hutchinson, HL.[2022]

In a study of 79 patients undergoing cardiac surgery, Exparel, when used as a single-dose parasternal nerve block, showed a marginal decrease in overall postoperative pain levels compared to a placebo, but this difference was not significant at individual time points.

Exparel did not demonstrate any opioid-sparing benefits or improvements in secondary outcomes such as length of hospital stay or recovery times, suggesting it may not be a superior option for pain management in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Liposomal Bupivacaine Parasternal Intercostal Block for Sternotomy. Lee, CY., Robinson, DA., Johnson, CA., et al.[2019]

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

In a study of 37 patients undergoing breast reduction surgery, the use of the long-acting local anesthetic bupivacaine (Sensorcaine) significantly reduced the time to discharge from the postanesthesia care unit, averaging 2.9 hours compared to 3.8 hours for the placebo group.

Patients who received Sensorcaine reported lower pain levels and required significantly less narcotic medication post-surgery, taking an average of 3.5 tablets compared to 6.4 tablets in the control group, indicating its efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. Culliford, AT., Spector, JA., Flores, RL., et al.[2021]

In a study of 34 patients undergoing breast augmentation, liposomal bupivacaine provided statistically significant lower pain scores compared to standard bupivacaine at multiple time points post-surgery, indicating it may offer better pain control.

Despite the statistical significance, the differences in pain relief were small, and 70% of patients felt the additional cost of liposomal bupivacaine was not justified by the benefits, suggesting limited clinical relevance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. Nadeau, MH., Saraswat, A., Vasko, A., et al.[2022]

In a study of 20 patients undergoing lingual nerve microsurgery, those who received liposomal bupivacaine (LB) reported significantly less postoperative pain and consumed fewer opioid pills compared to those who received bupivacaine hydrochloride (BH).

The findings suggest that LB, with its prolonged duration of action, is more effective in reducing postoperative pain and opioid consumption, supporting its use in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine use in exploratory lingual nerve microsurgery: does liposomal bupivacaine use decrease postoperative pain and opioid consumption compared to bupivacaine hydrochloride? A pilot study. Jacobus, D., Mehr, S., Ziccardi, V.[2021]

Citations

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jamanetwork.com

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Impact of liposomal bupivacaine on subjective recovery ...

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• Efficacy results from local exposure of bupivacaine from EXPAREL. • Safety is based on local effects and systemic bupivacaine exposure. Page ...

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These findings suggest that LB may be a safe and promising agent for prolonging postoperative analgesia and minimizing donor site pain. Some studies have ...