Clinical trial NCT06619340: EXPAREL IPSA Block in 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Pain, Postoperative
Osteo Arthritis Knee
Lead sponsor: Campbell Clinic
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain Assessment - 24hr recall
timeFrame: Study Enrollment, Post-operative Day 1, Post-operative Day 2, Post-operative Day 3, Post-operative Day 14, Post-operative Day 42
measure: Pain Assessment - current pain
timeFrame: 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
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
timeFrame: Enrollment, Post-operative Day 14, Post-operative Day 42
measure: Forgotten Joint Score
timeFrame: Post-operative Day 14, Post-operative Day 42
measure: Breakthrough Pain Assessment
timeFrame: In PACU before administration of breakthrough pain medication
measure: Patient Satisfaction with Pain Management
timeFrame: 12 hours after surgery, Post-operative Day 14, Post-operative Day 42
Other outcomes:
measure: Temperature
timeFrame: Before study medication administration, upon arrival in PACU, 12 hours after surgery
measure: Resting heart rate
timeFrame: Before study medication administration, upon arrival in PACU, 12 hours after surgery
measure: Blood pressure
timeFrame: Before study medication administration, upon arrival in PACU, 12 hours after surgery
measure: Respiratory rate
timeFrame: Before study medication administration, upon arrival in PACU, 12 hours after surgery
measure: Oxygen saturation
timeFrame: Before study medication administration, upon arrival in PACU, 12 hours after surgery
measure: Concomitant medication use
timeFrame: From signing informed consent form through 72 hours post-surgery.
measure: Adverse Event
timeFrame: From day of surgery to postoperative day 42
Locations:
city: Germantown
country: United States
facility: Campbell Clinic
state: Tennessee
Study officials:
affiliation: Campbell Clinic
name: William Mihalko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: