EXPAREL IPSA Block in Knee Arthroplasty

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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 a

Первичные конечные точки

• Pain Assessment - 24hr recall [Срок оценки: 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 [Срок оценки: 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]

Вторичные конечные точки (4)

• Knee Injury and Osteoarthritis Outcome Score for Joint Replacement [Срок оценки: Enrollment, Post-operative Day 14, Post-operative Day 42]
• Forgotten Joint Score [Срок оценки: Post-operative Day 14, Post-operative Day 42]
• Breakthrough Pain Assessment [Срок оценки: In PACU before administration of breakthrough pain medication]
• Patient Satisfaction with Pain Management [Срок оценки: 12 hours after surgery, Post-operative Day 14, Post-operative Day 42]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Campbell Clinic — Germantown

Идентификаторы

NCT: NCT06619340 · 24-10012-XP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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