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NCT07584915

Pilot Study on EXPAREL as an Intra-articular Posteromedial Surgeon Administered (IPSA) Block vs. Local Infiltration Analgesia in Knee Replacement Surgery

Enrolling by Invitation
PHASE4Ages 18+InterventionalTreatment
Cedars-Sinai Medical Center
~40 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:Intra-articular Posteromedial Surgeon Administered (IPSA) Block with LIALocal Infiltration Analgesia (LIA)Bupivacaine liposome injectable suspension (IPSA block)Bupivacaine liposome injectable suspension (LIA)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Post-Operative Pain Scores
Measured over Study participants will report Numerical Rating Scale (NRS) pain intensity scores throughout various timepoints between 0 to 72 hours post-surgery.

Conditions

Total Knee Arthroplasty
Total Knee Arthroplasty Recovery

Explore related trials

Degenerative Osteoarthritis of the KneeTotal Knee Replacement

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Andrew I Spitzer, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

18 years of age or older
Scheduled to undergo total knee arthroplasty (TKA) under spinal anesthesia
Primary indication for TKA is degenerative osteoarthritis of the knee
Able to provide informed consent, adhere to the study schedule, and complete all study assessments
Body Mass Index (BMI) ≥18 and \<40 kg/m2

Exclusion

Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)
Planned concurrent surgical procedure
Undergoing knee surgery for a single area of the knee or a revision surgery
History of knee replacement surgery within the past 6 months
History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
Previous participation in an EXPAREL study
Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance
Currently pregnant, nursing, or planning to become pregnant during the study
Any individual who, per standard of care, is excluded from the surgery due to possibility of pregnancy.
Male participant in a sexually active relation with pregnant or breastfeeding partner
Clinically significant medical disease that, in the opinion of the Investigator, would make participation in a clinical study inappropriate.
Any use of marijuana \[including Tetrahydrocannabinol (THC) and Cannabidiol (CBD)\] within 30 days prior to randomization, or planned use during the course of the study
Chronic opioid use within 30 days prior to surgery

What this trial measures

  • Post-Operative Pain ScoresStudy participants will report Numerical Rating Scale (NRS) pain intensity scores throughout various timepoints between 0 to 72 hours post-surgery.

    The primary outcome measure will be the Numerical Rating Scale (NRS) pain intensity scores reported by study participants. These results will be compared between both treatment groups.