Exparel Anesthetic for Total Knee Replacement

Overseen By Jaime Shuster, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Must not be taking: Opioids, NSAIDs, Marijuana, others

Disqualifiers: Allergies, Concurrent surgery, Addiction, others

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

Compensation: Varies

Number of Visits: 7

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to manage pain during and after knee replacement surgery using different types of pain relief medications. Participants will join one of three groups: one group receives a new type of knee joint injection (Exparel, an anesthetic), another receives a standard pain relief method, and the last receives an injection around the knee. The study will determine which method provides the most effective pain relief and patient satisfaction. Ideal participants are those undergoing knee replacement due to knee osteoarthritis and can follow the study requirements.

As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could improve pain management strategies for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you use marijuana or chronic opioids, you must stop 30 days before the study. It's best to discuss your specific medications with the study team.

What prior data suggests that this procedure is safe for knee surgery?

Research shows that EXPAREL, a type of pain relief medication, is generally well-tolerated by patients undergoing knee surgeries. Studies have found that EXPAREL can reduce the need for strong painkillers like opioids after surgery and may also shorten hospital stays. This indicates effective pain management without major complications.

Additionally, EXPAREL has been safely used in procedures like the adductor canal block, a method to relieve pain during knee surgeries. It delivers pain relief directly to the surgical area. The FDA approved EXPAREL in 2011 for these uses, providing confidence in its safety based on its track record.

For those considering joining the trial, it is important to know that EXPAREL has been well-studied. While no treatment is without risk, evidence so far shows it is usually safe for most people. Always discuss any concerns with the trial team or your doctor to gain a complete understanding. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for total knee replacement, which often involves techniques like the Adductor Canal Block (ACB) combined with Local Infiltration Analgesia (LIA), EXPAREL offers a unique approach. EXPAREL is a long-acting, non-opioid anesthetic that provides extended pain relief by slowly releasing bupivacaine over time. This can potentially reduce the need for additional pain medication and decrease opioid consumption after surgery. Researchers are excited about EXPAREL because it aims to improve pain management while minimizing side effects and enhancing recovery times.

What evidence suggests that this trial's treatments could be effective for pain management in knee surgery?

Research has shown that EXPAREL can help manage pain, leading to less pain and shorter hospital stays for some patients. One study found that patients using EXPAREL needed fewer opioids and incurred lower hospital costs. However, other studies found no major difference in pain relief or recovery compared to traditional treatments like bupivacaine hydrochloride. This trial will compare different approaches: Group 1 will receive an IPSA block and Local Infiltration Analgesia (LIA) with EXPAREL, Group 2 will receive the standard of care with an Adductor Canal Block (ACB) and LIA, and Group 3 will receive LIA alone. EXPAREL can be helpful for some, but its benefits might not be the same for everyone. Overall, EXPAREL might aid recovery by reducing the need for additional pain medication. ^{1 2 4 6 7}

Who Is on the Research Team?

Matthew Deren, MD

Principal Investigator

Associate Staff Orthopaedic Surgery

Are You a Good Fit for This Trial?

This trial is for individuals undergoing total knee replacement surgery. Participants must meet certain health criteria to be included, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

I am scheduled for knee replacement surgery under spinal anesthesia.

Body Mass Index (BMI) ≥18 and <40 kg/m2

I need a knee replacement due to arthritis.

Exclusion Criteria

I have reduced feeling in my legs below the knees.

Administration of an investigational drug within 30 days prior to study drug administration

Previous participation in an EXPAREL study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the assigned pain management treatment during knee surgery, including IPSA block, ACB, or LIA

1 day

1 visit (in-person, day of surgery)

Initial Follow-up

Participants are monitored for pain levels and satisfaction with pain management at 8, 24, 48, and 72 hours post-surgery

3 days

4 visits (in-person)

Extended Follow-up

Participants are monitored for safety, pain levels, and satisfaction with pain management at 14 days and 90 days post-surgery

90 days

2 visits (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• EXPAREL

Trial Overview The study tests the effectiveness of three pain management approaches during knee surgery: IPSA block with LIA, ACB with LIA (control group), and LIA alone. It measures pain relief, additional pain medication needs, patient satisfaction with pain management, and recovery progress.

How Is the Trial Designed?

Group I: Group 3 Experimental Treatment 1 Intervention

Patients in this group will receive Local Infiltration Analgesia (LIA).

Group II: Group 1 Experimental Treatment 1 Intervention

Patients in this group will receive IPSA block and Local Infiltration Analgesia (LIA).

Group III: Group 2-Control (Standard of Care) Active Control 1 Intervention

Patients in this group will receive Adductor Canal Block (ACB) and Local Infiltration Analgesia (LIA).

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Pacira Pharmaceuticals, Inc

Industry Sponsor

Trials

142

Recruited

14,300+

Headquarters

Tampa, USA

Known For

Non-opioid Pain Management

Top Products

Exparel, Zilretta, iovera

Dr. Jonathan Slonin

Pacira Pharmaceuticals, Inc

Chief Medical Officer since 2020

BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University

Frank D. Lee

Pacira Pharmaceuticals, Inc

Chief Executive Officer since 2024

BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business

Published Research Related to This Trial

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]

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]

EXPAREL® (bupivacaine liposome injectable suspension) has been shown to effectively reduce postoperative pain and opioid use in patients undergoing hip and knee arthroplasty, offering a safer alternative to traditional peripheral nerve blocks.

In a pilot study, patients receiving EXPAREL® reported lower pain scores and experienced significant cost savings of $411 for total knee arthroplasty and $348 for total hip arthroplasty compared to those receiving nerve blocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transition from nerve blocks to periarticular injections and emerging techniques in total joint arthroplasty. Springer, BD.[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]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2790975

Efficacy of Liposomal Bupivacaine and ... This study found that liposomal bupivacaine did not improve postoperative recovery or pain compared with bupivacaine hydrochloride alone among patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8988023/

Efficacy of Liposomal Bupivacaine and ... This study found no difference in postoperative recovery or pain associated with the use of periarticular liposomal bupivacaine compared with ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540322003758

Liposomal Bupivacaine in Adductor Canal Blocks Before ... Conclusion. Exparel peripheral regional nerve blocks lead to decreases in pain levels, shorter hospital lengths of stay, inpatient opioid usage, and improved ...

4. investor.pacira.com investor.pacira.com/news-releases/news-release-details/new-data-show-exparel-plays-key-role-achieving-significant

New Data Show EXPAREL Plays a Key Role in Achieving ... The findings show that patients receiving EXPAREL had a significant reduction in opioid use, hospital length of stay (LOS), and total hospitalization costs ...

5. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-023-03699-4

Liposomal bupivacaine administration is not superior to ... It is inconclusive whether LB offers better efficacy than traditional periarticular injection (TPAI) following total knee arthroplasty (TKA).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02011464

Evaluation Exparel Delivered in Knee Replacement Is to assess the efficacy of pain control of Exparel vs. · Asses the opioid use after Exparel vs. · Asses the time to simple and complex knee movement and ...

7. ajmc.com ajmc.com/view/study-measures-cost-patient-outcomes-after-total-knee-replacement

Study Measures Cost, Patient Outcomes After Total Knee ... The FDA approved Exparel in 2011 for a single-dose infiltration into the surgical site to produce postsurgical analgesia and is reviewing a ...