EXPAREL IPSA Block in Knee Arthroplasty

Enrolling by invitation · Phase 4

Conditions studied: Pain, Postoperative, Osteo Arthritis Knee

In brief

This is a case series to assess the clinical utility of an Intra-articular Posteromedial Surgeon Administered (IPSA) Block in patients undergoing primary unilateral total knee arthroplasty.

Key facts

Study ID

NCT06619340

Run by

Campbell Clinic

People needed

10

Starts

2024-05-20

Expected to finish

2025-12-31

Last updated by the study team

2024-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Indicated to undergo primary unilateral total knee arthroplasty under spinal anesthesia.
• Primary indication for TKA is degenerative osteoarthritis of the knee.
• American Society of Anesthesiologists physical status 1, 2, or 3.
• Able to provide informed consent, adhere to 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, non-steroidal anti-inflammatory drugs (NSAIDs)).
• Planned concurrent surgical procedure (e.g., bilateral TKA).
• Undergoing unicompartmental TKA or revision TKA.
• 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.
• Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted.
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• 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.
• 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.
• Chronic opioid use (average ≥30 oral morphine equivalents/day) within 30 days prior to surgery.

Where it is running

• Campbell Clinic — Germantown, Tennessee, United States

Full record on ClinicalTrials.gov

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