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ENROLLING BY INVITATION

NCT06619340

PHASE4

EXPAREL IPSA Block in Knee Arthroplasty

Sponsor: Campbell Clinic

View on ClinicalTrials.gov

Summary

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.

Official title: A Case Series Assessing the Clinical Utility of EXPAREL As an Intra-articular Posteromedial Surgeon Administered (IPSA) Block in Patients Undergoing Primary Unilateral Total Knee Arthroplasty

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-05-20

Completion Date

2025-12-31

Last Updated

2024-10-01

Healthy Volunteers

Conditions

Pain, Postoperative Osteo Arthritis Knee

Interventions

DRUG

Exparel

20 milliliter (mL) EXPAREL with 20mL bupivacaine hydrochloride (HCL) 0.5% will be expanded. An 18-gauge bevel needle will be introduced through the capsular pocket at 1 to 2cm proximal to the adductor tubercle at the proximal border of the posteromedial femoral condyle. The needle will be angled proximally and posteriorly, and then advanced to contact the posteromedial capsule. A 20mL bolus of the study drug admixture will be administered. The remaining 20mL of the study drug admixture will be administered to the anterior and lateral knee structures with approximately 1 to 1.5mL administered with each stick to the intended area.

Inclusion Criteria: 1. Indicated to undergo primary unilateral total knee arthroplasty under spinal anesthesia. 2. Primary indication for TKA is degenerative osteoarthritis of the knee. 3. American Society of Anesthesiologists physical status 1, 2, or 3. 4. Able to provide informed consent, adhere to study schedule, and complete all study assessments. 5. Body Mass Index (BMI) \> 18 and \< 40 kg/m2. Exclusion Criteria: 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, non-steroidal anti-inflammatory drugs (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. Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted. 6. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. 7. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance. 8. Currently pregnant, nursing, or planning to become pregnant during the study. 9. 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. 10. Chronic opioid use (average ≥30 oral morphine equivalents/day) within 30 days prior to surgery.

Locations (1)

Campbell Clinic

Germantown, Tennessee, United States