Exparel for Rotator Cuff Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The Cooper Health System

Disqualifiers: COPD, Respiratory issues, Liver disease, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day (surgery day)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well liposomal bupivacaine (Exparel) controls pain after rotator cuff surgery compared to the standard drug, bupivacaine. The researchers aim to determine if the new formula reduces pain and decreases the need for painkillers post-surgery. Participants will receive either the standard bupivacaine treatment or the experimental liposomal bupivacaine mix. It suits those undergoing rotator cuff surgery who are comfortable with using an interscalene block. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

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 these treatments?

Studies have shown that liposomal bupivacaine, known by the brand name Exparel, is generally safe for managing post-surgery pain. Research indicates that when used in nerve blocks, it can effectively relieve pain for up to 48 hours after surgery, potentially reducing the need for opioid painkillers.

Patients in various studies have tolerated the treatment well. Adding liposomal bupivacaine to nerve blocks significantly lowered pain levels without causing serious safety issues.

Liposomal bupivacaine is already FDA-approved for certain types of pain management, suggesting its safety. However, as with any medical treatment, discussing potential side effects and risks with a healthcare provider is always best. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Exparel for rotator cuff surgery because it offers an extended-release formulation of bupivacaine. Unlike standard bupivacaine, which provides pain relief for only a few hours, Exparel combines liposomal bupivacaine with regular bupivacaine to extend the pain relief effect for up to 72 hours. This means patients could experience less pain and potentially require fewer additional pain medications after surgery. The unique delivery system using liposomal technology is what sets Exparel apart, making it an innovative option for post-surgical pain management.

What is the effectiveness track record for liposomal bupivacaine in rotator cuff surgery?

Research shows that liposomal bupivacaine, also known as Exparel, helps manage pain after rotator cuff surgery. In this trial, some participants will receive an interscalene block with Exparel, an extended-release formulation of bupivacaine. Studies have found it can lower pain levels 24 to 72 hours after surgery and reduce the need for opioid painkillers for up to 96 hours. Patients who received liposomal bupivacaine experienced better pain relief compared to those who received only standard bupivacaine, which is another treatment arm in this trial. This long-lasting form of bupivacaine provides extended pain relief. Overall, liposomal bupivacaine has significantly improved recovery by reducing pain and the need for extra pain medication. ^{1 3 5 6 7}

Who Is on the Research Team?

Catherine J Fedorka, MD

Principal Investigator

The Cooper Health System

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having rotator cuff surgery and will receive an interscalene block. It's not for those unwilling to have this block, pregnant or nursing women, people with liver disease or severe lung conditions like COPD, or allergies to bupivacaine or liposomal bupivacaine.

Inclusion Criteria

I am over 18 years old.

I am having shoulder surgery with a specific type of anesthesia.

Exclusion Criteria

I have a liver condition.

I do not want to have an interscalene block procedure.

I have COPD or other lung problems that prevent certain anesthesia methods.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a standard interscalene block with bupivacaine or an interscalene block with Exparel solution during rotator cuff surgery

1 day (surgery day)

1 visit (in-person)

Postoperative Monitoring

Participants log their pain scores and narcotic consumption daily for 2 weeks post-surgery

2 weeks

1 visit (in-person) at 2 weeks

Follow-up

Participants are monitored for pain severity and opioid consumption at 6 and 12 weeks post-surgery

12 weeks

2 visits (in-person) at 6 and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine
• Liposomal Bupivacaine

Trial Overview

The study compares pain control and opioid use after rotator cuff surgery between two groups: one receiving a standard nerve block with bupivacaine alone, and the other getting a mix of liposomal bupivacaine plus regular bupivacaine. Participants are randomly assigned to either group.

How Is the Trial Designed?

Group I: Study- Exparel Experimental Treatment 1 Intervention

patients will receive an interscalene block with Exparel solution, which is an extended-release formulation of bupivacaine consisting of 10cc liposomal bupivacaine mixed with 15cc bupivacaine. This is approved and used at the study institution

Group II: Control- Bupivacaine Alone Active Control 1 Intervention

patients will receive a standard interscalene block with bupivacaine alone (25 cc of bupivacaine)

Who Is Running the Clinical Trial?

The Cooper Health System

Lead Sponsor

Trials

82

Recruited

35,600+

Published Research Related to This Trial

In a study involving 59 patients undergoing total knee arthroplasty, liposomal bupivacaine did not show a significant clinical advantage over standard bupivacaine in terms of postoperative recovery, as measured by the number of physical therapy sessions needed for discharge.

The use of liposomal bupivacaine was associated with higher medication charges, raising concerns about its cost-effectiveness compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine Versus Standard Periarticular Injection in Total Knee Arthroplasty With Regional Anesthesia: A Prospective Randomized Controlled Trial. Hyland, SJ., Deliberato, DG., Fada, RA., et al.[2019]

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]

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 352 patients undergoing shoulder surgery with an Exparel interscalene block, 16.5% experienced postoperative complications, with 6.0% leading to emergency department visits, highlighting the need for careful patient selection.

The American Society of Anesthesiologists (ASA) score was identified as a significant risk factor for both minor and major complications, suggesting that patients with higher ASA scores may be at greater risk when receiving this type of anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for complications and return to the emergency department after interscalene block using liposomal bupivacaine for shoulder surgery. Malige, A., Yeazell, S., Ng-Pellegrino, A., et al.[2021]

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]

In a retrospective analysis of 575 subjects across 6 clinical trials, liposome bupivacaine showed a similar safety profile to both bupivacaine HCl and normal saline, with 76% of liposome bupivacaine recipients experiencing adverse events (AEs).

The most common AEs for liposome bupivacaine included nausea and hypesthesia, and serious AEs occurred in 8% of subjects, indicating that the side effects are likely related to the surgical procedure rather than the medication itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Ilfeld, BM., Viscusi, ER., Hadzic, A., et al.[2022]

In a study of 76 patients undergoing outpatient arthroscopic rotator cuff repair, liposomal bupivacaine (LB) significantly reduced postoperative narcotic consumption compared to conventional bupivacaine combined with dexamethasone, indicating its effectiveness in pain management.

Both LB and LB combined with dexamethasone showed similar outcomes in narcotic use, suggesting that LB alone is sufficient for effective pain control, which can help decrease reliance on narcotics after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Shot Liposomal Bupivacaine Reduces Postoperative Narcotic Use Following Outpatient Rotator Cuff Repair: A Prospective, Double-Blinded, Randomized Controlled Trial. Baessler, AM., Moor, M., Conrad, DJ., et al.[2021]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9706058/

Quality of Recovery After Rotator Cuff Repair With ...

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The goal of this clinical trial is to investigate if there is a difference in pain after an arthroscopic rotator cuff surgery when a nerve block is performed ...

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sciencedirect.com/science/article/abs/pii/S1877056825000374

Liposomal Bupivacaine After Arthroscopic Rotator Cuff ...

LB moderately decreased pain scores 24 to 72 hours postoperatively and reduced opioid consumption for up to 96 hours following ARCR compared to ...

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pmc.ncbi.nlm.nih.gov/articles/PMC12007854/

Interscalene nerve block with plain bupivacaine versus ...

The goal of our study was to determine whether an interscalene block with liposomal bupivacaine provides superior analgesia and reduces opioid requirements.

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3% free bupivacaine provides patients with substantial, prolonged postoperative analgesia following shoulder surgery.

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Conclusions: Single-injection BPB with LB 133 mg provided analgesia through 48 hours postsurgery with reduced opioid use compared with placebo ...

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rapm.bmj.com

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Addition of liposomal bupivacaine in brachial plexus blocks

Liposomal bupivacaine was associated with statistically significant reduction in resting pain scores at 24 hours after nerve block injection ...