Surgeon-administered Exparel for pain control during total knee replacement

A Single-Center, Randomized, Pilot Study to Assess the Clinical Effectiveness of EXPAREL as an Intra-articular Posteromedial Surgeon Administered (IPSA) Block in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty

This study will test whether a surgeon‑administered Exparel IPSA block with local infiltration provides similar or better pain relief than an anesthesiologist‑administered adductor canal block for adults having a primary unilateral total knee replacement.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06946368 on ClinicalTrials.gov

What this trial studies

This single-center, randomized pilot study will enroll up to 60 adults undergoing primary unilateral total knee arthroplasty and randomize them 1:1:1 to receive surgeon‑administered IPSA block plus local infiltration analgesia (LIA), an anesthesiologist‑administered adductor canal block (ACB) with LIA, or LIA alone, using Exparel (liposomal bupivacaine) and bupivacaine HCl as appropriate. Treatments are given on the day of surgery under spinal anesthesia and participants are followed for pain, analgesic use, and satisfaction with pain management through 14‑ and 90‑day follow‑up calls, with overall involvement lasting about 123 days. The primary comparisons focus on postoperative pain control and opioid consumption, with safety and patient satisfaction also tracked. The protocol is conducted at Cleveland Clinic Lutheran Hospital and is sponsored by the Cleveland Clinic with Pacira Pharmaceuticals as a collaborator.

Who should consider this trial

Good fit: Adults age 18 or older scheduled for primary unilateral total knee arthroplasty for degenerative osteoarthritis under spinal anesthesia, with ASA physical status 1–3 and BMI between 18 and 40 kg/m2 who can consent and complete follow‑up are eligible.

Not a fit: Patients with allergy or contraindication to local anesthetics or study medications, those having concurrent or bilateral procedures, or those outside the BMI or ASA ranges are unlikely to benefit or to be eligible for this study.

Why it matters

Potential benefit: If successful, the surgeon‑administered IPSA approach could offer similar or improved postoperative pain control and comparable recovery while simplifying perioperative workflows.

How similar studies have performed: Adductor canal blocks and local infiltration analgesia are well established for knee replacement, while surgeon‑administered intra‑articular IPSA using Exparel is relatively novel and has limited direct comparative evidence.

Eligibility criteria

Inclusion Criteria: Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation:

1\. Subjects ages 18 or older at screening 2. Indicated to undergo primary unilateral total knee arthroplasty under spinal anesthesia 3. Primary indication for TKA is degenerative osteoarthritis of the knee 4. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3 (see Appendix 6) 5. Able to provide informed consent, adhere to the study schedule, and complete all study assessments 6. Body Mass Index (BMI) ≥18 and \<40 kg/m2

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Exclusion Criteria:

* Subjects who meet any of the following exclusion criteria will not be eligible for participation in this study:

  1. 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)
  2. Planned concurrent surgical procedure (e.g., bilateral TKA)
  3. Undergoing unicompartmental TKA or revision TKA
  4. Concurrent painful physical condition (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the knee surgery and which, in the Investigator's opinion, may confound the post dosing assessments
  5. Inadequate sensory function below the knee as assessed by the Investigator
  6. History of contralateral TKA within 1 year
  7. Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted
  8. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
  9. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
  10. Previous participation in an EXPAREL study
  11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance
  12. Currently pregnant, nursing, or planning to become pregnant during the study
  13. Clinically significant medical disease that, in the opinion of the Investigator, would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction or other conditions that would constitute a contraindication to participation in the study.
  14. 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
  15. Chronic opioid use (average ≥30 oral morphine equivalents/day) within 30 days prior to surgery

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic Lutheran Hospital — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Matthew Deren, MD — Associate Staff Orthopaedic Surgery
• Study coordinator: Sanalkumar Krishnan, PhD

Conditions Total Knee Arthroplasty; Exparel; Primary Unilateral Total Knee Arthroplasty; IPSA block