title: An extended paIn relief trial utilizing the infiltration of a long-acting Multivesicular liPosome foRmulation Of bupiVacaine, EXPAREL (IMPROVE): a Phase IV health economic trial in adult patients undergoing ileostomy reversal.
abstract: BACKGROUND
  Opioid analgesics are effective for postsurgical pain but are associated with opioid-related adverse events, creating a significant clinical and economic burden. Gastrointestinal surgery patients are at high risk for opioid-related adverse events. We conducted a study to assess the impact of an opioid-sparing multimodal analgesia regimen with liposome bupivacaine, compared with the standard of care (intravenous [IV] opioid-based, patient-controlled analgesia [PCA]) on postsurgical opioid use and health economic outcomes in patients undergoing ileostomy reversal.
  
  
  METHODS
  In this open-label, multicenter study, sequential cohorts of patients undergoing ileostomy reversal received IV opioid PCA (first cohort); or multimodal analgesia including a single intraoperative administration of liposome bupivacaine (second cohort). Rescue analgesia was available to all patients. Primary outcome measures were postsurgical opioid use, hospital length of stay, and hospitalization costs. Incidence of opioid-related adverse events was also assessed.
  
  
  RESULTS
  Twenty-seven patients were enrolled, underwent the planned surgery, and did not meet any intraoperative exclusion criteria; 16 received liposome bupivacaine-based multimodal analgesia and eleven received the standard IV opioid PCA regimen. The multimodal regimen was associated with significant reductions in opioid use compared with the IV opioid PCA regimen (mean, 20 mg versus 112 mg; median, 6 mg versus 48 mg, respectively; P < 0.01), postsurgical length of stay (median, 3.0 days versus 5.1 days, respectively; P < 0.001), and hospitalization costs (geometric mean, $6482 versus $9282, respectively; P = 0.01).
  
  
  CONCLUSIONS
  A liposome bupivacaine-based multimodal analgesic regimen resulted in statistically significant and clinically meaningful reductions in opioid consumption, shorter length of stay, and lower inpatient costs than an IV opioid-based analgesic regimen.
authors.affiliation: Department of Surgery, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.
authors.forename: Jorge E
authors.initials: JE
authors.lastname: Marcet
authors.forename: Valentine N
authors.initials: VN
authors.lastname: Nfonsam
authors.forename: Sergio
authors.initials: S
authors.lastname: Larach
keywords: hospitalization cost; ileostomy; length of stay; multimodal analgesia; opioid-related adverse events; surgery
references.citation: Dis Colon Rectum. 2006 Oct;49(10):1539-45
references.pmid: 16897328
references.citation: Ann R Coll Surg Engl. 2010 Jan;92(1):51-5
references.pmid: 20056062
references.citation: Arch Surg. 2011 Oct;146(10):1191-6
references.pmid: 22006879
references.citation: J Pain Symptom Manage. 2003 Mar;25(3):276-83
references.pmid: 12614962
references.citation: J Gastrointest Surg. 2008 Mar;12(3):437-41
references.pmid: 18095033
references.citation: Colorectal Dis. 2009 Oct;11(8):866-71
references.pmid: 19175627
references.citation: Int J Colorectal Dis. 2009 Jun;24(6):711-23
references.pmid: 19221766
references.citation: J Pain Res. 2012;5:567-72
references.pmid: 23204866
references.citation: Dis Colon Rectum. 2000 Feb;43(2):163-8
references.pmid: 10696888
references.citation: Pharmacoepidemiol Drug Saf. 2007 Jun;16(6):668-74
references.pmid: 17072916
references.citation: Ann Pharmacother. 2011 Jul;45(7-8):916-23
references.pmid: 21730280
references.citation: World J Surg. 2008 Sep;32(9):2101-6
references.pmid: 18563482
references.citation: J Pain. 2002 Jun;3(3):159-80
references.pmid: 14622770
references.citation: J Pain Res. 2012;5:107-16
references.pmid: 22570563
references.citation: Aust N Z J Surg. 1991 Jul;61(7):493-6
references.pmid: 1859308
references.citation: Am J Health Syst Pharm. 2007 Oct 15;64(20 Suppl 13):S3-7
references.pmid: 17909274
references.citation: Curr Med Res Opin. 2012 Oct;28(10):1609-15
references.pmid: 22900785
references.citation: Colorectal Dis. 2008 Jun;10(5):460-4
references.pmid: 17953706
references.citation: Dis Colon Rectum. 2008 Dec;51(12):1786-9
references.pmid: 18575937
references.citation: Clin J Pain. 2014 Feb;30(2):102-10
references.pmid: 23446090
references.citation: Am J Surg. 1999 Jun;177(6):463-6
references.pmid: 10414694
references.citation: Clin Ther. 2013 Mar;35(3):312-320.e5
references.pmid: 23453403
references.citation: J Clin Anesth. 2012 Aug;24(5):373-7
references.pmid: 22595759
references.citation: Ann Pharmacother. 2007 Mar;41(3):400-6
references.pmid: 17341537