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?

The study aims to test the safety and effectiveness of two different surgeon-administered methods of the anesthesia medication EXPAREL during knee replacement surgery. This study will not determine whether one method is better than the other, but will instead help the study investigator decide if both methods can provide an equal amount of pain relief.

The main question this study aims to answer is:

Will EXPAREL provide an equal amount of pain relief for patients who receive EXPAREL via Intra-articular Posteromedial Surgeon Administered (IPSA) Block and patients that receive EXPAREL via Local Infiltration Analgesia (LIA)?

Following their surgery, participants will be asked to report their pain level on their treated knee using a numerical rating scale (NRS) between 0 to 10. In addition to their pain level, participants will report any medications used for pain relief and will mark specific regions on an image to indicate where they experience pain.

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