By InvitationPhase 4

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

United States40 participantsStarted 2026-06-01

Plain-language summary

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 can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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 clini…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Post-Operative Pain Scores

Timeframe: Study participants will report Numerical Rating Scale (NRS) pain intensity scores throughout various timepoints between 0 to 72 hours post-surgery.

Trial details

NCT IDNCT07584915

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

View on ClinicalTrials.gov More Total Knee Arthroplasty trials