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

NCT07584915 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-13

No results posted yet for this study

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

Interventions

PROCEDURE

Intra-articular Posteromedial Surgeon Administered (IPSA) Block with 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.

PROCEDURE

Local Infiltration Analgesia (LIA)

The local infiltration analgesia (LIA) procedure involves the administration of anesthesia with the use of several needle sticks to areas surrounding the knee joint.

DRUG

Bupivacaine liposome injectable suspension (IPSA block)

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.

DRUG

Bupivacaine liposome injectable suspension (LIA)

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).

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    collaborator INDUSTRY

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07584915 on ClinicalTrials.gov