A Phase 4 interventional study of Intra-articular Posteromedial Surgeon Administered (IPSA) Block with LIA and Local Infiltration Analgesia (LIA) in Total Knee Arthroplasty and Total Knee Arthroplasty Recovery, sponsored by Cedars-Sinai Medical Center. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Cedars-Sinai Medical Center · Phase 4, Interventional, and Treatment
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.
Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
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Exclusion Criteria:
Group 1 will be assigned to receive the IPSA Block which is an innovative surgeon technique to administer anesthesia to a treated knee joint and will include the standard technique known as Local Infiltration Analgesia (LIA).
Procedure: Intra-articular Posteromedial Surgeon Administered (IPSA) Block with LIA · Drug: Bupivacaine liposome injectable suspension (IPSA block)
Group 2 will be assigned to receive Local Infiltration Analgesia (LIA) which is the standard anesthesia administration technique used for patients undergoing knee replacement surgery.
Procedure: Local Infiltration Analgesia (LIA) · Drug: Bupivacaine liposome injectable suspension (LIA)
The IPSA block is a specific surgeon technique which involves providing an injection of EXPAREL to the back of the knee, reaching into the joint space to provide pain relief. This arm will also receive the LIA procedure.
The local infiltration analgesia (LIA) procedure involves the administration of anesthesia with the use of several needle sticks to areas surrounding the knee joint.
Group 1 will be given an IPSA block using 10 mL of EXPAREL mixed with 10 mL of bupivacaine HCl 0.5%. An injection around the knee joint will be given as well utilizing a cocktail of: 10 mL of EXPAREL, 10 mL of bupivacaine HCl 0.5%, and 40 mL normal saline.
Group 2 will be given LIA with EXPAREL 20 mL (266 mg) mixed with 20 mL bupivacaine HCL 0.5% and 80 mL normal saline (total volume of 120 mL).
Post-Operative Pain Scores
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.
Time frame: Study participants will report Numerical Rating Scale (NRS) pain intensity scores throughout various timepoints between 0 to 72 hours post-surgery.
Plan to share: Yes — All de-identified IPD related to the study protocol will be shared.
Supporting information: Study protocol, Sap, Icf
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