Pilot Study on EXPAREL as an Intra-articular Posteromedial Surgeon Administered (IPSA) Block vs. Local Infiltration Analgesia in Knee Replacement Surgery

Официальное название

A Prospective, Single-Center, Randomized, Pilot Study to Assess the Clinical Effectiveness of EXPAREL as an Intra-articular Posteromedial Surgeon Administered (IPSA) Block Compared to Local Infiltration Analgesia in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty

Обзор

The study aims to test the safety and effectiveness of two different surgeon-administered methods of the anesthesia medication EXPAREL during knee replacement surgery. This study will not determine whether one method is better than the other, but will instead help the study investigator decide if both methods can provide an equal amount of pain relief. The main question this study aims to answer is: Will EXPAREL provide an equal amount of pain relief for patients who receive EXPAREL via Intra-articular Posteromedial Surgeon Administered (IPSA) Block and patients that receive EXPAREL via Local Infiltration Analgesia (LIA)? Following their surgery, participants will be asked to report their pain level on their treated knee using a numerical rating scale (NRS) between 0 to 10. In addition to their pain level, participants will report any medications used for pain relief and will mark specific regions on an image to indicate where they experience pain.

Вмешательства

• Процедура Intra-articular Posteromedial Surgeon Administered (IPSA) Block with LIA
  The IPSA block is a specific surgeon technique which involves providing an injection of EXPAREL to the back of the knee, reaching into the joint space to provide pain relief. This arm will also receive the LIA procedure.
• Процедура Local Infiltration Analgesia (LIA)
  The local infiltration analgesia (LIA) procedure involves the administration of anesthesia with the use of several needle sticks to areas surrounding the knee joint.
• Препарат Bupivacaine liposome injectable suspension (IPSA block)
  Group 1 will be given an IPSA block using 10 mL of EXPAREL mixed with 10 mL of bupivacaine HCl 0.5%. An injection around the knee joint will be given as well utilizing a cocktail of: 10 mL of EXPAREL, 10 mL of bupivacaine HCl 0.5%, and 40 mL normal saline.
• Препарат Bupivacaine liposome injectable suspension (LIA)
  Group 2 will be given LIA with EXPAREL 20 mL (266 mg) mixed with 20 mL bupivacaine HCL 0.5% and 80 mL normal saline (total volume of 120 mL).

Первичные конечные точки

• Post-Operative Pain Scores [Срок оценки: Study participants will report Numerical Rating Scale (NRS) pain intensity scores throughout various timepoints between 0 to 72 hours post-surgery.]

Критерии участия

Критерии включения

• 18 years of age or older
• Scheduled to undergo total knee arthroplasty (TKA) under spinal anesthesia
• Primary indication for TKA is degenerative osteoarthritis of the knee
• Able to provide informed consent, adhere to the 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, NSAIDs)
• Planned concurrent surgical procedure
• Undergoing knee surgery for a single area of the knee or a revision surgery
• History of knee replacement surgery within the past 6 months
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
• Previous participation in an EXPAREL study
• 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
• Any individual who, per standard of care, is excluded from the surgery due to possibility of pregnancy.
• Male participant in a sexually active relation with pregnant or breastfeeding partner
• Clinically significant medical disease that, in the opinion of the Investigator, would make participation in a clinical study inappropriate.
• Any use of marijuana \[including Tetrahydrocannabinol (THC) and Cannabidiol (CBD)\] within 30 days prior to randomization, or planned use during the course of the study
• Chronic opioid use 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

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Cedars-Sinai Medical Center — Los Angeles

Публикации

• Piuzzi NS, Spitzer AI, Mussell J, Pasqualini I, Dysart S, Gonzales J, Mont MA, Lonner JH, Mihalko W. Validation of a Novel Landmark-guided Intra-articular Postero-medial Surgeon-administered Injection Technique. Arthroplast Today. 2025 Jan 25;31:101619. doi: 10.1016/j.artd.2025.101619. eCollection 2025 Feb. PMID 39927121
• Dysart SH, Barrington JW, Del Gaizo DJ, Sodhi N, Mont MA. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Early Outcomes After Total Knee Arthroplasty: 24-Hour Data From the PILLAR Study. J Arthroplasty. 2019 May;34(5):882-886.e1. doi: 10.1016/j.arth.2018.12.026. Epub 2018 Dec 25. PMID 30799269
• Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ. Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J Arthroplasty. 2018 Jan;33(1):90-96. doi: 10.1016/j.arth.2017.07.024. Epub 2017 Jul 25. PMID 28802777
• Dysart S, Snyder MA, Mont MA. A Randomized, Multicenter, Double-Blind Study of Local Infiltration Analgesia with Liposomal Bupivacaine for Postsurgical Pain Following Total Knee Arthroplasty: Rationale and Design of the Pillar Trial. Surg Technol Int. 2016 Nov 11;30:261-267. PMID 27824434

Идентификаторы

NCT: NCT07584915 · Pro00003735

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗