TY - JOUR
T1 - Liposome Bupivacaine for Postsurgical Analgesia in Adult Patients Undergoing Laparoscopic Colectomy
T2 - Results from Prospective Phase IV Sequential Cohort Studies Assessing Health Economic Outcomes
AU - Candiotti, Keith A.
AU - Sands, Laurence R.
AU - Lee, Edward
AU - Bergese, Sergio D.
AU - Harzman, Alan E.
AU - Marcet, Jorge
AU - Kumar, Anjali S.
AU - Haas, Eric
N1 - Funding Information:
KC: Received research funding from Pacira Pharmaceuticals, Inc. LS: Received honorarium as a consultant from Pacira Pharmaceuticals, Inc. EL: Received a research grant from Pacira Pharmaceuticals, Inc. SB: No conflict of interest to disclose. AH: No conflict of interest to disclose. JM: Has no personal financial relationship to disclose; however, his employer, the University of South Florida, received a research grant for the Division of Sponsored Research from Pacira Pharmaceuticals, Inc. AK: No conflict of interest to disclose. EH: Served as a consultant for and received educational grants from Pacira Pharmaceuticals, Inc. This analysis was funded by Pacira Pharmaceuticals, Inc., which contributed to the study design, statistical analysis, manuscript preparation, and patient recruitment costs for the studies included in the analysis.
Funding Information:
This study is connected with US National Institutes of Health clinical trial identifiers NCT01460485, NCT01534988, NCT01509820, NCT01461122, NCT01461135, and NCT01963975. This analysis was funded by Pacira Pharmaceuticals, Inc. Editorial assistance was provided by Michael Morren, RPh, MBA, of Peloton Advantage, LLC, and was supported by Pacira Pharmaceuticals, Inc. The authors were fully responsible for the content, editorial decisions, and opinions expressed in the current article. All authors contributed equally. The authors did not receive an honorarium related to the development of this manuscript.
PY - 2014/12/1
Y1 - 2014/12/1
N2 - Background: Opioid-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. Methods: We 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. Results: Eighty-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. Conclusions: Compared 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.
AB - Background: Opioid-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. Methods: We 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. Results: Eighty-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. Conclusions: Compared 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.
KW - Hospitalization cost
KW - Laparoscopic colectomy
KW - Length of stay
KW - Multimodal analgesia
KW - Opioid-related adverse events
KW - Surgery
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U2 - 10.1016/j.curtheres.2013.12.001
DO - 10.1016/j.curtheres.2013.12.001
M3 - Article
AN - SCOPUS:84903271553
VL - 76
SP - 1
EP - 6
JO - Current Therapeutic Research
JF - Current Therapeutic Research
SN - 0011-393X
ER -