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

NCT07584915 | Enrolling By Invitation Phase 4

• 1 other identifier: Pro00003735
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Knee Arthroplasty; Total Knee Arthroplasty Recovery

Keywords

intra-articular posteromedial; local infiltration analgesia; knee replacement surgery; EXPAREL

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

Group 1 - Study Group

EXPERIMENTAL

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 - Control Group

ACTIVE COMPARATOR

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)

Interventions

Local Infiltration Analgesia (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 2 - Control Group

Bupivacaine liposome injectable suspension (IPSA block) DRUG

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 1 - Study Group

Intra-articular Posteromedial Surgeon Administered (IPSA) Block with LIA PROCEDURE

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.

Group 1 - Study Group

Bupivacaine liposome injectable suspension (LIA) DRUG

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).

Group 2 - Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (4)

• Piuzzi NS, Spitzer AI, Mussell J, Pasqualini I, Dysart S, Gonzales J, Mont MA, Lonner JH, Mihalko W. Validation of a Novel Landmark-guided Intra-articular Postero-medial Surgeon-administered Injection Technique. Arthroplast Today. 2025 Jan 25;31:101619. doi: 10.1016/j.artd.2025.101619. eCollection 2025 Feb.

  PMID: 39927121 BACKGROUND

• Dysart SH, Barrington JW, Del Gaizo DJ, Sodhi N, Mont MA. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Early Outcomes After Total Knee Arthroplasty: 24-Hour Data From the PILLAR Study. J Arthroplasty. 2019 May;34(5):882-886.e1. doi: 10.1016/j.arth.2018.12.026. Epub 2018 Dec 25.

  PMID: 30799269 BACKGROUND

• Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25.

  PMID: 28802777 BACKGROUND

• Dysart S, Snyder MA, Mont MA. A Randomized, Multicenter, Double-Blind Study of Local Infiltration Analgesia with Liposomal Bupivacaine for Postsurgical Pain Following Total Knee Arthroplasty: Rationale and Design of the Pillar Trial. Surg Technol Int. 2016 Nov 11;30:261-267.

  PMID: 27824434 BACKGROUND

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Andrew I Spitzer, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Both treatment groups will receive the same anesthesia medication (EXPAREL), but each group will receive the medication in a different way. Each group will be assigned a different surgeon-administered anesthesia technique.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be available between April 1, 2026 until the end of the study.
• Access Criteria: Access to individual participant data will be limited to collaborators (ie, Pacira) collaborating as defined in the collaborative agreement. De-identified or coded data will be shared solely for analyses related to the objectives of the study. Data will not be made publicly available or shared with external third parties.

Locations

US (1)