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
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pain Assessment - 24hr recall
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Able to provide informed consent, adhere to study schedule, and complete all study assessments.
- •Body Mass Index (BMI) > 18 and < 40 kg/m2.
排除标准
- •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.
研究组 & 干预措施
Experimental Group
Patients will receive an EXPAREL IPSA block intraoperatively.
干预措施: Exparel (Drug)
结局指标
主要结局
Pain Assessment - 24hr recall
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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)
研究者
William M. Mihalko
Professor, Department of Orthopaedic Surgery and Biomechanical Engineering
Campbell Clinic