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2017-08-11
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Administration Case Report With EXPAREL This case report represents the individual experience of Dr Stan Dysart and is intended to demonstrate his methodology for using EXPAREL in a specific orthopedic procedure. Pacira Pharmaceuticals, Inc., recognizes that there are alternative methodologies for administering local anesthetics, as well as individual patient considerations, when selecting the dose for a specific procedure. EXPAREL is indicated for administration into the surgical site to produce postsurgical analgesia. CASE INFORMATION Physician Name Stan Dysart, MD Affiliation Pinnacle Orthopaedics/Wellstar Health System Surgical Case Performed Total knee arthroplasty (TKA) Inpatient or Outpatient Procedure Inpatient PATIENT CHARACTERISTICS Gender Male Age 81 years Patient History and Characteristics Patient previously underwent a successful left TKA Pathology Patient has right knee osteoarthritis and is now undergoing a right TKA with an ERAS protocol PROCEDURAL DETAILS Incision Size 15 cm Preoperative Analgesics Used AC block—20 mL of 0.25% bupivacaine with epinephrine Intraoperative Analgesics Used TIVA general—150-200 mcg/kg/min propofol titrated based on surgical needs; 50-100 mcg fentanyl as needed Periarticular injection with 20 mL EXPAREL and 50 mL 0.25% bupivacaine Dose of EXPAREL and Total Volume Used 20 mL EXPAREL + 50 mL Bupivacaine 0.25% + 50 mL Normal Saline = 120 mL Total AC, adductor canal; ERAS, enhanced recovery after surgery; TIVA, total intravenous anesthesia. T he recommended dose of EXPAREL is based on the size of the surgical site, the volume required to cover the area, and individual patient factors that may impact the safety of an amide local anesthetic. The maximum dose of EXPAREL should not exceed 266 mg. EXPAREL can be administered undiluted (20 mL) or diluted to increase volume up to a total of 300 mL (final concentration of 0.89 mg/mL [ie, 1:14 dilution by volume]) with normal (0.9%) saline or lactated Ringer’s solution. Bupivacaine HCl may be administered immediately before EXPAREL or admixed in the same syringe, as long as the ratio of the milligram dose of bupivacaine HCl to EXPAREL does not exceed 1:2. Admixing may impact the pharmacokinetic and/or physiochemical properties of EXPAREL, and this effect is concentration dependent. The toxic effects of these drugs are additive and their administration should be used with caution, including monitoring for neurological and cardiovascular effects related to toxicity. Other than with bupivacaine, EXPAREL should not be admixed with other drugs prior to administration. lease see Important Safety Information on the last page and refer to the accompanying full Prescribing Information for P complete Dosage and Administration information before using EXPAREL. INFILTRATION NOTES INFILTRATION NOTES (cont) ASSESSED THE SIZE OF THE SURGICAL SITE AND DEPTH OF TISSUE, THEN PREPARED INJECTION MATERIALS ACCORDINGLY In this procedure, Dr Dysart determined that a total volume of approximately 120 mL would be needed to cover the surgical site. He expanded 20 mL of EXPAREL with 50 mL of normal saline and admixed this solution with 50 mL of 0.25% bupivacaine. Dr Dysart added bupivacaine to provide short-term local analgesia in the postanesthesia care unit that overlapped with the long-term local analgesia provided by EXPAREL. DIVIDED INJECTATE INTO SYRINGES WITH NEEDLE GAUGES APPROPRIATE FOR INFILTRATION (20- TO 25-GAUGE) AND PLANNED WHICH AREAS TO INFILTRATE WITH EACH INJECTION # S yringe #2: Medial and lateral infiltration of femoral periosteal/synovial tissues and of suprapatellar tissue with 20 needle sticks of 1 mL to 1.5 mL per injection Inject until a noticeable bubble forms. It is normal for there to be more dramatic swelling in this thick, fibrous layer than when soft tissue is infiltrated. FIGURE 2. Femoral periosteal/synovial and suprapatellar tissues For this procedure, Dr Dysart divided the injectate evenly into six 20-mL syringes using a 21-gauge needle and infiltrated as follows: # # 6 # 5 # # 2 3 6 ■ Syringe #1: Posterior capsule S yringe #3: Injection of fat pad, pes anserinus, MCL, and medial gutter, saturating the area ■ Syringe #2: Femur FIGURE 3. Fat pad, pes anserinus, MCL, and medial gutter ■ Syringe #3: Tibia, pes anserinus, 2 #5 # # # PRIOR TO CEMENTATION 1 medial collateral ligament (MCL), gutter ■ Syringe #4: Circumferential periosteum AFTER CEMENTATION ■ Syringe #5: Quadriceps tendon, retinaculum, medial gutter 4 S yringe #4: Medial and lateral infiltration of the circumferential periosteum of the tibia using 15 to 20 needle sticks ■ Syringe #6: Lateral gutter, FIGURE 4. Circumferential periosteum of tibia subcutaneous tissue # 3 # 3 Adapted with permission; International Guidelines Center (guidelinecentral.com)—Erin Daniel, illustrator. S yringe #5: INFILTRATED AFTER THE BONY CUTS WERE PERFORMED After completing the bony cuts, Dr Dysart inserted a laminar spreader between the cut femur and tibia, exposing the posterior capsule of the knee. He then proceeded with infiltrating the injectate as follows: Injection of the synovial tissue beneath the quadriceps tendon and the retinacular tissue medially from the femur to the tibia S yringe #1: FIGURE 5. Synovial tissue (quadriceps) and medial retinacular tissue (femur to tibia) Medial and lateral infiltration of the posterior capsule • Medial infiltration of posterior capsule with approximately 10 needle sticks to create a field block S yringe #6: • Lateral infiltration of posterior capsule with approximately 10 needle sticks FIGURE 1. Posterior capsule Before each injection, be sure to aspirate to minimize the risk of intravascular injection. Be sure not to inject too far laterally, and monitor the volume injected because of the proximity of the peroneal nerve. Injection of the lateral gutter and the lateral retinacular tissue from the femur to the tibia. Residual volume is used in the subcutaneous tissue medially and laterally. There will likely be swelling of the tissue from fluid volume When infiltrating, stay in the tissue to reduce the amount of extravasation. FIGURE 6. Lateral gutter and retinacular tissue (femur to tibia) lease see Important Safety Information on the last page and refer to the accompanying full Prescribing Information for P complete Dosage and Administration information before using EXPAREL. INFILTRATION NOTES (cont) PROPER TECHNIQUE IS CRUCIAL FOR ANALGESIC COVERAGE EXPAREL Bupivacaine When infiltrating EXPAREL, Dr Dysart makes sure to infiltrate below the fascia, above the fascia, and into the subcutaneous tissue using a moving needle technique. With a moving needle technique, the injections are spread in a rapid and precise fan-like pattern to maximize the number of injection areas. The tissues are infiltrated as the needle is advanced and withdrawn to maximize the coverage area. This technique should be systematically and meticulously repeated with each subsequent injection site, and the next site should overlap with the prior infiltrated area to maximize effect. W atch Dr Dysart infiltrate with EXPAREL at www.EXPAREL.com Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. EXPAREL is not recommended to be used in the following patient population: patients <18 years old and/or pregnant patients. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. Warnings and Precautions Specific to EXPAREL EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks, or intravascular or intra-articular use. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Formulations of bupivacaine other than EXPAREL should not be administered within 96 hours following administration of EXPAREL. Warnings and Precautions for Bupivacaine-Containing Products Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesias. CNS reactions are characterized by excitation and/or depression. Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability which may lead to dysrhythmias sometimes leading to death. Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients. Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use. Disclosure: Dr Dysart is a paid consultant for Pacira Pharmaceuticals, Inc. ©2017 Pacira Pharmaceuticals, Inc., Parsippany, NJ 07054 PP-EX-US-2065 01/17
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