EXPAREL IPSA Block in Knee Arthroplasty

Phase 4

• Conditions: Pain, Postoperative; Osteo Arthritis Knee
• Interventions: Drug: Exparel

• Registration Number: NCT06619340
• Lead Sponsor: Campbell Clinic

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.

Study Timeline

• Study Start: 2024-05-20
• Study First Submitted: 2024-07-24
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-26
• Last Update Submitted: 2024-09-26
• Study First Posted: 2024-09-30
• Last Update Posted: 2024-09-30
• Primary Completion: 2025-05-20
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Group	Exparel	Patients will receive an EXPAREL IPSA block intraoperatively.

Primary Outcome Measures

Name	Time	Method
Pain Assessment - 24hr recall	Study Enrollment, Post-operative Day 1, Post-operative Day 2, Post-operative Day 3, Post-operative Day 14, Post-operative Day 42	On a 0-10 scale, record worst pain in the last 24 hours and average pain in the last 24 hours, with 0 being no pain at all and 10 being the worst pain possible.
Pain Assessment - current pain	Study Enrollment, On Admission to Surgery, on Post Anesthesia Care Unit (PACU) Admission, every 15 minutes from PACU admission to discharge home, 12 hours after surgery, Post-operative Day (POD) 1, POD 2, POD 3, POD 14, POD 42	On a 0-10 scale, record current pain level, with 0 being no pain at all and 10 being the worst pain possible.

Secondary Outcome Measures

Name	Time	Method
Breakthrough Pain Assessment	In PACU before administration of breakthrough pain medication	On a 0-10 scale, record current pain score before administration of breakthrough pain medication in PACU where 0 represents no pain at all and 10 represents worst pain possible.
Patient Satisfaction with Pain Management	12 hours after surgery, Post-operative Day 14, Post-operative Day 42	On a 0-10 scale, record patient's satisfaction with pain management where 0 represents not satisfied at all and 10 represents very satisfied.
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement	Enrollment, Post-operative Day 14, Post-operative Day 42	Patient reported outcome on overall knee health where 0 represents total knee disability and 100 represents perfect knee health.
Forgotten Joint Score	Post-operative Day 14, Post-operative Day 42	Patient reported outcome on patient's awareness of their artificial joint. The higher the score, the less aware the patient is about their joint during activities of daily living.

Trial Locations

Locations (1)

Campbell Clinic; 🇺🇸 Germantown, Tennessee, United States