Effectiveness of Exparel Anesthetic Administered by the Surgeon During Knee Surgery

Launched by THE CLEVELAND CLINIC · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to manage pain for patients undergoing total knee replacement surgery, specifically looking at an anesthetic called Exparel. The trial will compare three different methods of pain relief: one method where the surgeon injects the anesthetic directly into the knee joint (IPSA block), another method where the anesthetic is given near a nerve in the thigh (Adductor Canal Block), and a third method that uses only injections around the knee (Local Infiltration Analgesia). The goal is to find out which method works best for reducing pain after surgery, how much additional pain medication might be needed, and how satisfied patients are with their pain management.

To participate, individuals must be 18 years or older and scheduled for knee replacement surgery due to arthritis. They should be in generally good health, as determined by a doctor. However, there are some conditions that would exclude someone from participating, like allergies to the medications used, certain medical issues, or a history of substance abuse. Participants will be randomly assigned to one of the three treatment groups and will receive careful monitoring to assess their pain relief and overall recovery experience.

Gender

ALL

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
• • -
• 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