Extended pain relief trial utilizing infiltration of Exparel®, a long-acting multivesicular liposome formulation of bupivacaine: a Phase IV health economic trial in adult patients undergoing open colectomy

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Open Access Full Text Article Extended pain relief trial utilizing infiltration of Exparel®, a long-acting multivesicular liposome formulation of bupivacaine: a Phase IV health economic trial in adult patients undergoing open colectomy This article was published in the following Dove Press journal: Journal of Pain Research 19 November 2012 Number of times this article has been viewed Stephen M Cohen Atlanta Colon and Rectal Surgery, PA, Atlanta, GA, USA Correspondence: Stephen M Cohen Atlanta Colon and Rectal Surgery, PA, 33 Upper Riverdale Rd, #127, Riverdale, GA 30274, USA Tel +1 770 997 1975 Fax +1 770 997 1966 Email submit your manuscript | www.dovepress.com Dovepress http://dx.doi.org/10.2147/JPR.S38621 Powered by TCPDF (www.tcpdf.org) Background: The majority of surgical patients experience significant levels of pain after a procedure. While opioid analgesics have been a mainstay of postsurgical analgesic regimens, recent evidence has supported the use of multimodal therapy as a way to decrease opioid usage with its concomitant opioid-related adverse events. The goal of multimodal therapy is to minimize the negative effects of these events on clinical and economic outcomes. The purpose of this study was to assess the opioid burden and health economic outcomes in patients undergoing open colectomy who received a liposomal bupivacaine-based multimodal analgesic regimen as compared with a standard opioid-based regimen for postsurgical pain. Methods: In this open-label, single-center, sequential-cohort study, adults undergoing open colectomy were assigned to treatment via patient-controlled analgesia with opioids (first cohort) or multimodal analgesia therapy including a single administration of liposomal bupivacaine (second cohort). Both treatment groups were offered rescue analgesia as needed. The main outcome measures were total mg amount of opioids consumed after surgery, total hospital costs, and length of hospital stay. Adverse events, including opioid-related adverse events, were recorded. Results: Thirty-nine patients were enrolled, 18 in the opioid-based analgesia group and 21 in the multimodal analgesia group. Mean total amount of postsurgical opioids consumed was significantly less in the multimodal analgesia group (57 mg) compared with the opioid analgesia group (115 mg; P = 0.025). The average total cost of hospitalization in the multimodal group was $8766 versus $11,850 in the opioid group (P = 0.027), and the median length of hospital stay was 2.0 days versus 4.9 days, respectively (P = 0.004). Conclusion: This study confirmed that a liposomal bupivacaine–based multimodal analgesic regimen resulted in less opioid consumption, lower hospital costs, and a shorter length of stay than a standard opioid-based analgesic regimen for postsurgical pain in patients undergoing open colectomy. Keywords: surgery, multimodal analgesia, opioid consumption, cost, length of stay Introduction During the past two decades, there has been heightened awareness about the importance of perioperative pain management, and several clinical guidelines have been published with a focus on the treatment of perioperative pain.1–4 However, a large proportion of patients continue to experience significant pain following both inpatient and Journal of Pain Research 2012:5 567–572 © 2012 Cohen, publisher and licensee Dove Medical Press Ltd. This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited. 567 Dovepress Journal of Pain Research downloaded from https://www.dovepress.com/ by 210.91.111.167 on 23-May-2020 For personal use only. Cohen outpatient surgeries.5–8 Balancing the need for adequate postsurgical pain relief while minimizing treatment-related adverse effects is a key factor for timely patient recovery and ambulation, as well as patient satisfaction after surgery.4,9–12 While opioids are effective analgesics and continue to be a mainstay of postsurgical pain management regimens, opioidrelated adverse events are common and the clinical and economic burden associated with these events is significant.11 Data from previous studies suggest a reduction in opioidrelated adverse events may result in shorter length of hospital stay and lower hospital costs.11 Liposomal bupivacaine (Exparel®, Pacira Pharmaceuticals Inc, Parsippany, NJ) is an extended-release formulation of bupivacaine designed to allow drug diffusion to occur for up to 72 hours following a single administration at the end of surgery. It is indicated for single-dose administration into the surgical site to produce postsurgical analgesia.13 The objective of this study was to assess total opioid burden and health economic outcomes in adult patients undergoing open colectomy with general anesthesia who received a multimodal regimen that included liposomal bupivacaine for postsurgical pain compared with those who received patient-controlled analgesia (PCA) with opioids. Materials and methods This single-center, Phase IV, prospective, open-label, sequential study evaluated the pharmacoeconomic outcomes associated with a multimodal analgesia regimen including a single administration of liposomal bupivacaine 266 mg given via wound infiltration at the end of surgery, compared with an analgesia regimen including PCA with intravenous morphine or hydromorphone. The study was conducted by the author at Southern Regional Medical Center, Riverdale, GA, from December 2011 to June 2012 (US National Institutes of Health Clinical Trials Identifier NCT01207246). The protocol was approved by a central institutional review board, and the study was conducted in accordance with the International Conference on Harmonisation Good Clinical Practice guidelines.14 Written informed consent was obtained from all patients before any study procedures were conducted. Patients Adults $ 18 years of age undergoing open segmental colectomy with anastomosis (cecectomy, right or left hemicolectomy, resection of transverse colon, or sigmoidectomy) were included in the study. Patients were excluded from participation in the study if they were pregnant, had a history of drug/ alcohol abuse, or had severe hepatic impairment or any other 568 Powered by TCPDF (www.tcpdf.org) submit your manuscript | www.dovepress.com Dovepress concomitant condition that, in the opinion of the investigator, could make the patient an inappropriate candidate for the study. Those who required unplanned multiple resections of the large intestine or unplanned colostomies placed during surgery were excluded, as well as those who required administration of intraoperative analgesics (other than fentanyl), nonsteroidal anti-inflammatory drugs, local anesthetics (other than liposo (...truncated)