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

Stephen M Cohen, Jon D Vogel, Jorge E Marcet, Keith A Candiotti, Stephen M Cohen, Jon D Vogel, Jorge E Marcet, Keith A Candiotti

Abstract

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.

Keywords: analgesia; bupivacaine; gastrointestinal surgery; opioid analgesics; postoperative pain.

Figures

Figure 1
Figure 1
Mean per-patient postsurgical opioid consumption; amounts are expressed in morphine mg equivalents. Notes: Error bars represent SD; P<0.0001 for the between-group comparison. Abbreviations: IV, intravenous; PCA, patient-controlled analgesia; SD, standard deviation.
Figure 2
Figure 2
Median postsurgical LOS in days. Notes: Error bars represent 95% CIs for the median; P<0.0001 for the between-group comparison. Abbreviations: CIs, confidence intervals; IV, intravenous; LOS, length of stay; PCA, patient-controlled analgesia.
Figure 3
Figure 3
Geometric mean per-patient total cost of hospitalization (US$). Note:P=0.0109 for the between-group comparison. Abbreviations: IV, intravenous; PCA, patient-controlled analgesia.

References

    1. Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003;97(2):534–540.
    1. Gan TJ, Habib AS, White W, Miller T. Postoperative pain continues to be undermanaged [abstract]; Presented at: Annual Fall Pain Meeting and Workshops of the American Society of Regional Anesthesia and Pain Medicine; November 15–18, 2012; Miami Beach, FL.
    1. Warfield CA, Kahn CH. Acute pain management. Programs in US hospitals and experiences and attitudes among US adults. Anesthesiology. 1995;83(5):1090–1094.
    1. American Society of Anesthesiologists Task Force on Acute Pain Management Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012;116(2):248–273.
    1. Oderda GM, Said Q, Evans RS, et al. Opioid-related adverse drug events in surgical hospitalizations: impact on costs and length of stay. Ann Pharmacother. 2007;41(3):400–406.
    1. Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002;3(3):159–180.
    1. Kessler ER, Shah M, Gruschkus K, Raju A. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013;33(4):383–391.
    1. Oderda GM, Gan TJ, Johnson BH, Robinson SB. Effect of opioid-related adverse events on outcomes in selected surgical patients. J Pain Palliat Care Pharmacother. 2013;27(1):62–70.
    1. Wu CL, Raja SN. Treatment of acute postoperative pain. Lancet. 2011;377(9784):2215–2225.
    1. Senagore AJ. Pathogenesis and clinical and economic consequences of postoperative ileus. Am J Health Syst Pharm. 2007;64(20 Suppl 13):S3–S7.
    1. Barletta JF, Asgeirsson T, Senagore AJ. Influence of intravenous opioid dose on postoperative ileus. Ann Pharmacother. 2011;45(7–8):916–923.
    1. Artinyan A, Nunoo-Mensah JW, Balasubramaniam S, et al. Prolonged postoperative ileus-definition, risk factors, and predictors after surgery. World J Surg. 2008;32(7):1495–1500.
    1. Cali RL, Meade PG, Swanson MS, Freeman C. Effect of morphine and incision length on bowel function after colectomy. Dis Colon Rectum. 2000;43(2):163–168.
    1. Zhao SZ, Chung F, Hanna DB, Raymundo AL, Cheung RY, Chen C. Dose-response relationship between opioid use and adverse effects after ambulatory surgery. J Pain Symptom Manage. 2004;28(1):35–46.
    1. Exparel® (bupivacaine liposome injectable suspension) [prescribing information] Parsippany, NJ: Pacira Pharmaceuticals, Inc.; 2012.
    1. Cohen SM. Extended pain relief trial utilizing infiltration of Exparel®, a long-acting multivesicular liposome formulation of bupivacaine: a Phase IV health economic trial in adult patients undergoing open colectomy. J Pain Res. 2012;5:567–572.
    1. Vogel JD. 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. J Pain Res. 2013;6:605–610.
    1. Marcet JE, Nfonsam VN, Larach S. An extended paIn relief trial utilizing the infiltration of a long-acting Multivesicular liPosome foRmulation Of bupiVacaine, EXPAREL (IMPROVE): a Phase IV health economic trial in adult patients undergoing ileostomy reversal. J Pain Res. 2013;6:549–555.
    1. Candiotti KA, Sands LR, Lee E, et al. Liposome bupivacaine for postsurgical analgesia in adult patients undergoing laparoscopic colectomy: results from prospective phase IV sequential cohort studies assessing health economic outcomes. Curr Ther Res. 2014;76:1–6.
    1. Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107–116.
    1. Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012;28(10):1609–1615.
    1. Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011;54(12):1552–1559.
    1. Smoot JD, Bergese SD, Onel E, Williams HT, Hedden W. The efficacy and safety of DepoFoam bupivacaine in patients undergoing bilateral, cosmetic, submuscular augmentation mammoplasty: a randomized, double-blind, active-control study. Aesthet Surg J. 2012;32(1):69–76.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit