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

Trial Summary

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 data supports the effectiveness of the drug Exparel for total knee replacement?

Exparel, a long-acting anesthetic, has been shown to provide similar pain relief to femoral nerve blocks after total knee replacement, with benefits like improved early walking and shorter hospital stays. Additionally, studies have found that Exparel can reduce pain scores and opioid use in various surgeries, suggesting its effectiveness in managing postoperative pain. ^{1 2 3 4 5}

Is Exparel safe for use in humans?

Exparel (bupivacaine liposome injectable suspension) has been shown to be safe and effective in reducing postoperative pain across various surgical procedures, including orthopedic surgeries, when used as part of a multimodal pain management regimen. ^{2 3 4 5 6}

How does the drug Exparel differ from other treatments for pain management in total knee replacement?

Exparel is unique because it is an extended-release anesthetic that is injected directly into the surgical site, providing long-lasting pain relief and reducing the need for opioids. Unlike traditional nerve blocks, Exparel offers benefits such as improved early ambulation and decreased hospital stay without compromising pain relief. ^{1 2 3 4 6}

What is the purpose of this trial?

Intra-articular Posteromedial Surgeon Administered (IPSA) Block in this study describes a new type of medical procedure where a surgeon provides anesthetic medication directly into a specific area inside a knee joint to numb the pain during knee surgery. Intra-articular refers to inside of knee joint, posteromedial refers to the back and inner side of a knee joint, and surgeon administered means a surgeon is performing the procedure. Patients You will be randomly assigned to one of these three treatment groups: Group 1: Patients in this group will receive IPSA block and Local Infiltration Analgesia (LIA). IPSA block is a pain numbing medication given by surgeon and injected inside the back and inner side of the knee joint. Local Infiltration Analgesia is a pain numbing medication injection given by the surgeon around the surgical knee area. The medications used in the procedure will be EXPAREL, and Bupivacaine HCL. Group 2 (Control): Patients in this group will receive Adductor Canal Block (ACB) and Local Infiltration Analgesia (LIA). ACB is a pain numbing injection given by anesthesiologist near the adductor canal, a passage in the mid-thigh that contains nerves connecting the knee region. Local Infiltration Analgesia is a pain numbing medication injection given by the surgeon around the surgical knee area. The medications used in the procedure will be EXPAREL, and Bupivacaine HCL. Group 3: Patients in this group will receive Local Infiltration Analgesia (LIA). Local Infiltration Analgesia is a pain numbing medication injection given by the surgeon around the surgical knee area. The medications used in the procedure will be EXPAREL, and Bupivacaine HCL. The study will evaluate; * How effective the pain relief is after surgery. * How much extra pain medication you need. * Your satisfaction with pain management and recovery * Any side effects.

Research Team

Matthew Deren, MD

Principal Investigator

Associate Staff Orthopaedic Surgery

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

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

The use of exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. [2022]

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

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

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

Transition from nerve blocks to periarticular injections and emerging techniques in total joint arthroplasty. [2022]

4. 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]

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

Assessment of liposome bupivacaine infiltration versus continuous femoral nerve block for postsurgical analgesia following total knee arthroplasty: a retrospective cohort study. [2019]

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

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