Liposome Bupivacaine for Postsurgical Analgesia in Adult Patients Undergoing Laparoscopic Colectomy: Results from Prospective Phase IV Sequential Cohort Studies Assessing Health Economic Outcomes

Abstract

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.

Keywords: hospitalization cost; laparoscopic colectomy; length of stay; multimodal analgesia; opioid-related adverse events; surgery.

Figures

Fig. 1

(A) Front view of infiltration path for administration of liposome bupivacaine into subcutaneous and dermal regions. About 4 mL study drug solution was administered on each side of the surgical site following the paths shown. (B) Axial view of infiltration depth into subcutaneous and dermal regions. The dotted line shows depth of liposome bupivacaine administration. Reprinted with permission from Best Infiltration Practices: Local Analgesic Infiltration Techniques for Abdominal Surgery PocketGuide. Copyright © 2012 International Guidelines Center. www.GuidelineCentral.com. All rights reserved.

Fig. 2

(A) Front view of infiltration path for administration of liposome bupivacaine into perifascial regions. About 1 mL study drug solution was administered to deep tissue on each side of the surgical site following the paths shown. (B) Axial view of infiltration depth into perifascial (deep tissue) regions. The dotted line shows depth of liposome bupivacaine administration. Reprinted with permission from Best Infiltration Practices: Local Analgesic Infiltration Techniques for Abdominal Surgery PocketGuide. Copyright © 2012 International Guidelines Center. www.GuidelineCentral.com. All rights reserved.

Fig. 3

(A) Front view of anticipated trocar sites. About 10 mL study drug solution was divided and administered across trocar sites. The dotted arrows show locations for trocar placement. (B) Axial view of liposome bupivacaine infiltration into the trocar tract. Reprinted with permission from Best Infiltration Practices: Local Analgesic Infiltration Techniques for Abdominal Surgery PocketGuide. Copyright © 2012 International Guidelines Center. www.GuidelineCentral.com. All rights reserved.