EXPAREL IPSA Block in Knee Arthroplasty

NCT ID: NCT06619340

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-20
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

EXPAREL is approved by the Food and Drug Administration (FDA) for use in adults to produce postsurgical regional analgesia via an adductor canal block. The purpose of this study is to evaluate the clinical utility of a surgeon administered EXPAREL adductor canal block intraoperatively in patients undergoing primary unilateral total knee arthroplasty (TKA).

Patients will not be randomized - all patients will receive an EXPAREL IPSA block intraoperatively. Visual Analog Scale, patient reported outcomes, and patient's satisfaction with pain management will be recorded. Adverse events will be monitored.

Conditions

Pain, Postoperative; Osteo Arthritis Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

Patients will receive an EXPAREL IPSA block intraoperatively.

Group Type: EXPERIMENTAL

Exparel

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Campbell Clinic

OTHER

Sponsor Role: lead

Responsible Party

William M. Mihalko

Professor, Department of Orthopaedic Surgery and Biomechanical Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Mihalko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Campbell Clinic

Locations

Campbell Clinic

Germantown, Tennessee, United States

Countries

United States

Other Identifiers

24-10012-XP

Identifier Type: -

Identifier Source: org_study_id