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

Corresponding Author:  Keith A. Candiotti

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.

Source: Current Therapeutic Research, Volume 76, December 2014, Pages 1–6

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Further Comments

This paper reports results from a prospective, multicenter, open-label study of liposome bupivacaine (known as the IMPROVE or Extended PaIn Relief Trial Utilizing the Infiltration of a Long-Acting Multivesicular LiPosome FoRmulation Of BupiVacaine, Exparel  trial) that evaluated opioid burden and health economic outcomes in patients undergoing laparoscopic colectomy who were treated with either a multimodal analgesic regimen that included a single intraoperative administration of liposome bupivacaine 266 mg (n=26) or a standard of care, opioid-based analgesic regimen (n=56). The mean total amount of opioids consumed (morphine equivalents) after surgery was 32 mg in the liposome bupivacaine-based multimodal analgesia group versus 96 mg in the IV opioid/PCA group (P less than 0.0001). Median durations of hospital stay were 3.0 days versus 4.0 days (P=0.002) in the multimodal and IV opioid PCA groups, respectively; total cost of hospitalization was $11,234 and $13,018 (P=0.26), respectively. Opioid-related adverse events were experienced by 2 (8%) patients in the multimodal analgesia group versus 23 (41%; P=0.002) in the IV opioid PCA group. These results equate to a statistically-significant 67% reduction in mean total amount of opioids consumed after surgery, a median postsurgical length of hospital stay that was shorter by 1 day, and an 80% reduction in the proportion of patients experiencing opioid-related adverse events.