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)

160 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Exparel for rotator cuff surgery?

Research suggests that liposomal bupivacaine, the active ingredient in Exparel, may help reduce postoperative pain and decrease the need for narcotics after rotator cuff surgery. Studies have shown that it can provide longer-lasting pain relief compared to conventional bupivacaine, especially when used in combination with other medications like dexamethasone. ^{1 2 3 4 5}

Is Exparel (liposomal bupivacaine) safe for use in humans?

Exparel, a form of liposomal bupivacaine, is generally considered safe for use in humans and has been approved by the FDA for pain relief in various surgeries, including breast augmentation and shoulder surgeries. However, it can have side effects that may lead to emergency department visits, especially when used in certain types of nerve blocks for shoulder surgery. ^{1 2 3 6 7}

How is the drug Exparel different from other treatments for rotator cuff surgery?

Exparel is unique because it is a long-acting local anesthetic that uses a special liposomal formulation to release bupivacaine slowly over time, providing extended pain relief after surgery. This is different from standard treatments that may require more frequent dosing or have shorter durations of action. ^{1 3 6 8 9}

What is the purpose of this trial?

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 with liposomal bupivacaine versus the standard treatment of bupivacaine alone. The main question aims to answer if patients who receive liposomal bupivacaine have better pain control and lower postoperative opioid consumption compared to bupivacaine alone. Participants be randomized to either the control group to receive a standard interscalene block with bupivacaine (25 cc of bupivacaine) or the experimental group to receive similar dosing of liposomal bupivacaine mixed with bupivacaine (10cc liposomal bupivacaine + 15cc bupivacaine). Data will be prospectively collected and the data from the experimental group will be compared to the control group at the completion of the study period.

Research Team

Catherine J Fedorka, MD

Principal Investigator

The Cooper Health System

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine infiltration in the surgical site for analgesia after rotator cuff repair: a randomized, double-blinded, placebo-controlled trial. [2021]

2. Germany 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. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]

4. United States 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Comparing liposomal bupivacaine plus bupivacaine to bupivacaine alone in interscalene blocks for rotator cuff repair surgery: a randomized clinical trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Risk factors for complications and return to the emergency department after interscalene block using liposomal bupivacaine for shoulder surgery. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine Versus Standard Periarticular Injection in Total Knee Arthroplasty With Regional Anesthesia: A Prospective Randomized Controlled Trial. [2019]