EXPAREL for Pain Relief in Knee Replacement

(CRS-121 Trial)

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of two methods for using the anesthesia medication EXPAREL during knee replacement surgery. The goal is to determine if both methods offer the same level of pain relief post-surgery. Participants will report their pain levels and any pain medication used. This trial suits individuals with degenerative osteoarthritis who are scheduled for a full knee replacement. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

Do I have to stop taking my current medications for the trial?

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

What is the safety track record for EXPAREL?

Research has shown that EXPAREL is generally safe for use in knee replacement surgery. One study found that patients tolerate EXPAREL, a long-lasting pain medication, well when combined with another anesthetic, meaning it usually doesn't cause serious side effects. Another study demonstrated that patients using EXPAREL experienced similar safety outcomes to those using standard pain relief methods, with only a few minor side effects reported. These findings suggest that EXPAREL is a safe option for managing pain during knee replacement surgeries.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the use of EXPAREL for knee replacement pain relief because it offers a novel approach to anesthesia delivery. Unlike traditional methods such as Local Infiltration Analgesia (LIA), EXPAREL is administered through an innovative surgeon technique called the IPSA Block, which targets the knee joint more directly. This could potentially enhance pain management and improve recovery times for patients undergoing knee replacement surgery. By incorporating EXPAREL, the treatment aims to provide longer-lasting pain relief with a single administration, reducing the need for additional pain medications post-surgery.

What evidence suggests that EXPAREL is effective for pain relief in knee replacement surgery?

Research has shown that EXPAREL, a type of anesthesia, helps manage pain after knee replacement surgery. In this trial, participants in Group 1 will receive the IPSA Block technique with EXPAREL, which includes the standard Local Infiltration Analgesia (LIA). Studies have found that EXPAREL can reduce the need for strong painkillers like opioids and may even shorten hospital stays. Specifically, one study found that EXPAREL provided similar pain relief to standard methods while helping patients move sooner and leave the hospital earlier. Another study noted that patients experienced little pain in the first two days after surgery with EXPAREL. Overall, EXPAREL appears to reduce pain and improve recovery after knee surgery.14567

Who Is on the Research Team?

AI

Andrew I Spitzer, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for adults 18 or older who are scheduled for knee replacement surgery due to osteoarthritis, have a BMI between 18 and 40, will get spinal anesthesia, and can follow study instructions.

Inclusion Criteria

I am 18 years old or older.
My main reason for knee replacement is knee osteoarthritis.
I am scheduled for total knee replacement with spinal anesthesia.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo knee replacement surgery and receive either the IPSA Block or Local Infiltration Analgesia (LIA) for pain management

Immediate post-surgery
1 visit (in-person)

Post-operative Monitoring

Participants report pain levels using a Numerical Rating Scale (NRS) and record any medications used for pain relief

0 to 72 hours post-surgery
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • EXPAREL

Trial Overview

The study compares two ways of giving the pain medication EXPAREL during knee replacement: one method injects it near the back inside part of the knee (IPSA block), while the other spreads it around the joint area (local infiltration). Both methods aim to control pain after surgery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Group 1 - Study GroupExperimental Treatment2 Interventions
Group II: Group 2 - Control GroupActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials
523
Recruited
165,000+

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 profile image

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

Citations

A prospective, randomized trial of liposomal bupivacaine ...

The study demonstrated that LB ACBs led to significantly lower opioid consumption in the days following TKA without affecting pain scores or length of stay.

Two New Studies Support Use of EXPAREL for ...

Data Presented at 2014 Annual Meeting of the American Academy of Orthopedic Surgeons Show EXPAREL Improved Pain Scores , Lowered Opioid Consumption, ...

Effectiveness of Exparel Anesthetic Administered by the ...

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.

4.

clinicaltrials.cedars-sinai.edu

clinicaltrials.cedars-sinai.edu/view/CRS-121

EXPAREL Compared to Local Infiltration Analgesia in Primary ...

The study aims to determine whether both methods can provide an equal amount of pain relief for patients undergoing knee replacement surgery. The standard ...

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 ...

Liposomal bupivacaine in knee replacement surgery

This study aims to evaluate the effectiveness of liposomal bupivacaine versus standard bupivacaine on post-operative recovery for total knee replacement ...

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 ...