Data Presented at the Annual Meeting of the American Academy of Orthopaedic Surgeons
PARSIPPANY, N.J., March 13, 2019 (GLOBE NEWSWIRE) -- Pacira Pharmaceuticals, Inc. (PCRX) today announced new data showing that a patient-optimizing, opioid-sparing enhanced recovery after surgery (ERAS) pathway, which includes intraoperative infiltration with EXPAREL® (bupivacaine liposome injectable suspension), results in high rates of early discharge and patient satisfaction among Medicare-insured patients undergoing total knee or hip arthroplasty (TKA or THA). Findings also demonstrate that the vast majority of patients do not require more than a 7-day opioid prescription following discharge. The research was detailed during a podium presentation at the American Academy of Orthopaedic Surgeons (AAOS) 2019 Annual Meeting in Las Vegas.
Retrospective chart review data were captured for 645 consecutive Medicare patients who underwent primary inpatient TKA (337 patients) or THA (308 patients) between June 1, 2015, and November 16, 2017. All patients followed a procedure-specific ERAS protocol; key findings included:
• 84% of patients were same-day discharged to home, without home services, following their joint replacement
• 84.2% did not require any additional opioid prescriptions beyond the initial 7-day prescription provided at discharge
- Nationally, 38% of knee replacement patients are still taking opioids 2 months after surgery
• Patients reported high satisfaction with their perioperative experience
- 98.9% of patients reported they would recommend the surgical facility “very much” or “a good amount”
- 98.3% were “very much” or “a good amount” satisfied with their pain management
- >97% were “very much” or “a good amount” satisfied with the education and communication they received
• Comparable or lower complication rates to nationally reported rates
“Our findings suggest that potential exists for Medicare-insured patients to undergo safe and successful TKA or THA procedures as outpatient surgery with same-day discharge to home. Since the completion of our study, more than ninety percent of patients safely and comfortably go home the day of surgery,” said Orthopedic Surgeon James Van Horne, of Paragon Orthopedic Center in Grants Pass, OR, who performed all 645 surgeries and authored this analysis. “This ERAS protocol, which was developed over the last ten years to maximize the number of Medicare patients who could safely and reproducibly undergo outpatient joint replacement, suggests an important advance in our ability to offer these patients quality care that meets the ‘Triple Aim’ of healthcare by improving the patient experience and population health while reducing healthcare costs.”
All patients received a procedure-specific ERAS protocol that included:
• Presurgical physical, medical, and social optimization: including assistance with stabilization of medical issues/modifiable risk factors; postsurgical rehabilitation training; and development of a social support network
• Individualized multimodal pain management: including a non-opioid pain management regimen started one week preoperatively; spinal anesthesia, awake sedation and local infiltration with EXPAREL and bupivacaine HCl intraoperatively; and a non-opioid pain management regimen alongside a 7-day supply of opioids as needed postoperatively
• Patient and caregiver education before and after surgery: including setting realistic expectations for pain; opioid risks and tapering instructions; and wound care information
“Dr. Van Horne’s analysis is particularly timely, given that outpatient TKA and THA are rapidly growing in volume, and are estimated to be performed in the outpatient setting more than 50% of the time within the next decade1,” said Dave Stack, chief executive officer and chairman of Pacira. “These data demonstrate the significant patient, clinical, and economic outcomes that are attainable for our Medicare patients in the outpatient setting when a thoughtful, thorough patient-optimizing, opioid-sparing ERAS protocol is employed.”
Dr. Van Horne’s podium presentation, entitled Enhanced Recovery After Surgery Pathway for Total Knee and Hip Arthroplasty in a Medicare Population: Implications for a Transition to Ambulatory Surgery Centers, was Paper 151 at AAOS. It was presented from the podium on Tuesday, March 12 at 1:30 pm PT.
Pacira Pharmaceuticals, Inc. (PCRX) is a specialty pharmaceutical company dedicated to advancing and improving postsurgical outcomes for acute care practitioners and their patients. The company’s flagship product, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.
EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. Adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via interscalene brachial plexus nerve block were nausea, pyrexia, and constipation. If EXPAREL and other non-bupivacaine local anesthetics, including lidocaine, are administered at the same site, there may be an immediate release of bupivacaine from EXPAREL. Therefore, EXPAREL may be administered to the same site 20 minutes after injecting lidocaine. 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. Warnings and Precautions Specific to EXPAREL: Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, or intravascular or intra-articular use. The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials. 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 paresthesia. 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. Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use. Full Prescribing Information is available at www.EXPAREL.com.
Pacira Pharmaceuticals, Inc.
Susan Mesco, 973-451-4030
Coyne Public Relations
Alyssa Schneider, 973-588-2270
1. Bert JM, Hooper J, Moen S. Outpatient total joint arthroplasty. Curr Rev Musculoskelet Med 2017;10:567-74.