Liposome bupivacaine (EXPAREL®) for extended pain relief in patients undergoing ileostomy reversal at a single institution with a fast-track discharge protocol: an IMPROVE Phase IV health economics trial

Abstract

Background: Postoperative opioid use following ileostomy reversal procedures contributes to postoperative ileus. We assessed the impact of a liposome bupivacaine-based, opioid-sparing multimodal analgesia regimen versus a standard opioid-based analgesia regimen on postsurgical opioid use. We also assessed health economic outcomes in patients undergoing ileostomy reversal at our institution, which employs an enhanced recovery discharge protocol.

Methods: In this single-center, open-label study, patients undergoing ileostomy reversal received postsurgical pain therapy via multimodal analgesia that included a single intraoperative administration of liposome bupivacaine or opioid-based patient-controlled analgesia (PCA) with intravenous morphine or hydromorphone. Rescue analgesia (intravenous [IV] opioids and/or oral opioid + acetaminophen) was available to all patients. Primary efficacy measures included postsurgical opioid use, hospital length of stay (LOS), and hospitalization costs. Secondary measures included: time to first rescue opioid use; patient satisfaction with analgesia; additional medical intervention; and opioid-related adverse events.

Results: Forty-three patients were enrolled and met eligibility criteria (IV opioid PCA group = 20; liposome bupivacaine-based multimodal analgesia group = 23). Postsurgical opioid use was significantly less in the multimodal analgesia group compared with the IV opioid PCA group (mean [standard deviation]: 38 mg [46 mg] versus 68 mg [47 mg]; P = 0.004). Postsurgical LOS between-group differences (median: 3.0 days versus 3.8 days) and geometric mean hospitalization costs (US $6,611 versus US$6,790) favored the multimodal analgesic group but did not achieve statistical significance. Median time to first opioid use was 1.1 hours versus 0.7 hours in the multimodal analgesia and IV opioid PCA groups, respectively; P = 0.035. Two patients in the multimodal analgesia group and one in the IV opioid PCA group experienced opioid-related adverse events.

Conclusion: A liposome bupivacaine-based multimodal analgesic regimen reduced postoperative opioid consumption in patients undergoing ileostomy reversal under a fast-track discharge protocol. A reduction of 21% in LOS (0.8 days) was noted which, although not statistically significant, may be considered clinically meaningful given the already aggressive fast-track discharge program.

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

Figures

Figure 1

Postsurgical opioid use. Notes: Mean total amount (morphine equivalent mg) of postsurgical opioids consumed per patient; error bars represent standard deviation. P = 0.004 for the between-group comparison. Abbreviations: IV, intravenous; PCA, patient-controlled analgesia; SD, standard deviation.

Figure 2

Postsurgical length of stay. Notes: Median postsurgical length of hospital stay (days). Error bars represent the range for 95% of values around the median. Postsurgical length of stay ranged from 2.0 days to 6.9 days in the opioid analgesia group and from 1.4 days to 14.6 days in the multimodal analgesia group. P = 0.854 for the between-group comparison. Abbreviations: IV, intravenous; PCA, patient-controlled analgesia.

Figure 3

Total cost of hospitalization. Notes: Geometric least-squares mean per-patient hospitalization costs (US$). P = 0.8 for the between-group comparison. Abbreviations: IV, intravenous; PCA, patient-controlled analgesia.