EXPAREL IPSA Block in Knee Arthroplasty

NCT06619340 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 24-10012-XP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (2)

• Pain Assessment - 24hr recall

  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.

  Study Enrollment, Post-operative Day 1, Post-operative Day 2, Post-operative Day 3, Post-operative Day 14, Post-operative Day 42

• Pain Assessment - current pain

  On a 0-10 scale, record current pain level, with 0 being no pain at all and 10 being the worst pain possible.

  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 (4)

• Knee Injury and Osteoarthritis Outcome Score for Joint Replacement

  Enrollment, Post-operative Day 14, Post-operative Day 42

• Forgotten Joint Score

  Post-operative Day 14, Post-operative Day 42

• Breakthrough Pain Assessment

  In PACU before administration of breakthrough pain medication

• Patient Satisfaction with Pain Management

  12 hours after surgery, Post-operative Day 14, Post-operative Day 42

Other Outcomes (7)

• Temperature

  Before study medication administration, upon arrival in PACU, 12 hours after surgery

• Resting heart rate

  Before study medication administration, upon arrival in PACU, 12 hours after surgery

• Blood pressure

  Before study medication administration, upon arrival in PACU, 12 hours after surgery

Study Arms (1)

Experimental Group

EXPERIMENTAL

Patients will receive an EXPAREL IPSA block intraoperatively.

Drug: Exparel

Interventions

Exparel 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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Campbell Clinic: lead

Study Sites (1)

Campbell Clinic

Germantown, Tennessee, 38138, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• William Mihalko, MD, PhD

  Campbell Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Orthopaedic Surgery and Biomechanical Engineering

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: October 1, 2024
• Study Start: May 20, 2024
• Primary Completion: May 20, 2025
• Study Completion: December 31, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)