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Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis.

ABSTRACT: UNLABELLED:Postsurgical pain management remains a significant challenge. Liposome bupivacaine, as part of a multimodal analgesic regimen, has been shown to significantly reduce postsurgical opioid consumption, hospital length of stay (LOS), and hospitalization costs in gastrointestinal (GI) surgery, compared with intravenous (IV) opioid-based patient-controlled analgesia (PCA). Pooled results from open-label studies comparing a liposome bupivacaine-based multimodal analgesic regimen with IV opioid PCA were analyzed. Patients (n=191) who underwent planned surgery and received study drug (IV opioid PCA, n=105; multimodal analgesia, n=86) were included. Liposome bupivacaine-based multimodal analgesia compared with IV opioid PCA significantly reduced mean (standard deviation [SD]) postsurgical opioid consumption (38 [55] mg versus [vs] 96 [85] mg; P<0.0001), postsurgical LOS (median 2.9 vs 4.3 days; P<0.0001), and mean hospitalization costs (US$8,271 vs US$10,726; P=0.0109). The multimodal analgesia group reported significantly fewer patients with opioid-related adverse events (AEs) than the IV opioid PCA group (P=0.0027); there were no significant between-group differences in patient satisfaction scores at 30 days. A liposome bupivacaine-based multimodal analgesic regimen was associated with significantly less opioid consumption, opioid-related AEs, and better health economic outcomes compared with an IV opioid PCA-based regimen in patients undergoing GI surgery. STUDY REGISTRATION:This pooled analysis is based on data from Phase IV clinical trials registered on the US National Institutes of Health www.ClinicalTrials.gov database under study identifiers NCT01460485, NCT01507220, NCT01507233, NCT01509638, NCT01509807, NCT01509820, NCT01461122, NCT01461135, NCT01534988, and NCT01507246.

SUBMITTER: Cohen SM

PROVIDER: S-EPMC4075953 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis.

Cohen Stephen M SM Vogel Jon D JD Marcet Jorge E JE Candiotti Keith A KA

Journal of pain research 20140624

<h4>Unlabelled</h4>Postsurgical pain management remains a significant challenge. Liposome bupivacaine, as part of a multimodal analgesic regimen, has been shown to significantly reduce postsurgical opioid consumption, hospital length of stay (LOS), and hospitalization costs in gastrointestinal (GI) surgery, compared with intravenous (IV) opioid-based patient-controlled analgesia (PCA). Pooled results from open-label studies comparing a liposome bupivacaine-based multimodal analgesic regimen with ...[more]

PMID: 25018650

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Project description:BackgroundOpioid-based postsurgical analgesia exposes patients undergoing laparoscopic colectomy to elevated risk for gastrointestinal motility problems and other opioid-related adverse events (ORAEs). The purpose of our research was to investigate postsurgical outcomes, including opioid consumption, hospital length of stay, and ORAE risk associated with a multimodal analgesia regimen, employing a single administration of liposome bupivacaine as well as other analgesics that act by different mechanisms.MethodsWe analyzed combined results from 6 Phase IV, prospective, single-center studies in which patients undergoing laparoscopic colectomy received opioid-based intravenous patient-controlled analgesia (PCA) or multimodal analgesia incorporating intraoperative administration of liposome bupivacaine. As-needed rescue therapy was available to all patients. Primary outcome measures were postsurgical opioid consumption, hospital length of stay, and hospitalization costs. Secondary measures included time to first rescue opioid use, patient satisfaction with analgesia (assessed using a 5-point Likert scale), and ORAEs.ResultsEighty-two patients underwent laparoscopic colectomy and did not meet intraoperative exclusion criteria (PCA n = 56; multimodal analgesia n = 26). Compared with the PCA group, the multimodal analgesia group had significantly lower mean total postsurgical opioid consumption (96 vs 32 mg, respectively; P < 0.0001) and shorter median postsurgical hospital length of stay (3.0 vs 4.0 days; P = 0.0019). Geometric mean costs were $11,234 and $13,018 in the multimodal analgesia and PCA groups, respectively (P = 0.2612). Median time to first rescue opioid use was longer in the multimodal analgesia group versus PCA group (1.1 hours vs 0.6 hours, respectively; P=0.0003). ORAEs were experienced by 41% of patients receiving intravenous opioid PCA and 8% of patients receiving multimodal analgesia (P = 0.0019). Study limitations included use of an open-label, nonrandomized design; small population size; and the inability to isolate treatment-related effects specifically attributable to liposome bupivacaine.ConclusionsCompared with intravenous opioid PCA, a liposome bupivacaine-based multimodal analgesia regimen reduced postsurgical opioid use, hospital length of stay, and ORAEs, and may lead to improved postsurgical outcomes following laparoscopic colectomy.

Project description:BackgroundThe 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.MethodsIn 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.ResultsThirty-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).ConclusionThis 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.

Dataset Information

Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis.

Publications

Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis.

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