Safety of liposome extended-release bupivacaine for postoperative pain control

Juan Portillo, Nawal Kamar, Somayah Melibary, Eduardo Quevedo, Sergio Bergese, Juan Portillo, Nawal Kamar, Somayah Melibary, Eduardo Quevedo, Sergio Bergese

Abstract

Background: Ideal postoperative pain management requires a multidisciplinary approach in combination with a variety of dosage regimens. Approximately 21-30% of patients experience moderate to severe pain in the postoperative period, which may have a significant impact on recovery rate, standard of living, psychological health, and postoperative complications.

Objective: Analysis of the incidence and characterization of reported adverse effects with DepoFoam bupivacaine compared to conventional bupivacaine or placebo.

Methods: A systematic review of prospective studies on the use of DepoFoam versus bupivacaine or placebo was performed in order to answer the clinically relevant question: is DepoFoam a safer formulation in place of bupivacaine single injection or continuous local infusion techniques for postoperative pain management? Inclusion criteria required randomized, controlled, double-blind trials in patients 18 years old or older, single dose used for postoperative pain control, and a primary procedure performed.

Results: Six studies fitted the inclusion criteria for analysis, DepoFoam bupivacaine used in therapeutic doses was well-tolerated, had a higher safety margin, and showed a favorable safety profile compared to bupivacaine and control groups.

Conclusion: Extended drug delivery system DepoFoam bupivacaine is a promising drug formulation that may significantly improve postoperative care and pain control in surgical patients.

Keywords: bupivacaine; bupivacaine HCl; depofoam; exparel; liposome bupivacaine.

Figures

FIGURE 1
FIGURE 1
Most common adverse effects reported (incidence above 5.0%).

References

    1. About DepoFoam. (2011). Pacira Pharmaceuticals, Inc., Parsipanny, NJ, USA. Available at: [accessed July 16, 2012].
    1. Apfelbaum J. L., Chen C., Mehta S. S., Gan T. J. (2003). Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth. Analg. 97 534–540 10.1213/01.ANE.0000068822.10113.9E
    1. Beilin Y., Halpern S. (2010). Ropivacaine versus bupivacaine for epidural labor analgesia. Anesth. Analg. 111 482–487 10.1213/ANE.0b013e3181e3a08e
    1. Bergese S. D., Onel E., Morren M., Morganroth J. (2012). Bupivacaine extended-release liposome injection exhibits a favorable cardiac safety profile. Reg. Anesth. Pain Med. 37 145–151 10.1097/AAP.0b013e31823d0a80
    1. Bergese S., Onel E., Portillo J. (2011). Evaluation of DepoFoam bupivacaine for the treatment of postsurgical pain. Pain Manag. 1 539–547 10.2217/pmt.11.62
    1. Borgeat A., Dollenkopf A., Ekatodramis G., Nagy L. (2003). Evaluation of the lateral modified approach for continuous interscalene block after shoulder surgery. Anesthesiology 99 436–442
    1. Bramlett K., Onel E., Viscusi E. R., Jones K. (2012). A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee 19 530–536 10.1016/j.knee.2011.12.004
    1. Chahar P, Cummings K. C., III (2012). Liposomal bupivacaine: a review of a new bupivacaine formulation. J. Pain Res. 5 257–264 10.2147/JPR.S27894
    1. Cullen K. A., Hall M. J., Golosinskiy A. (2009). Ambulatory surgery in the United States, 2006. Natl. Health Stat. Report. 11 1–25
    1. Ersayli D. T., Gurbet A., Bekar A., Uckunkaya N., Bilgin H. (2006). Effects of perioperatively administered bupivacaine and bupivacaine-methylprednisolone on pain after lumbar discectomy. Spine 31 2221–2226 10.1097/01.brs.0000232801.19965.a0
    1. Golf M., Daniels S. E., Onel E. (2011). A phase 3, randomized, placebo-controlled trial of DepoFoam® bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv. Ther. 28 776–788 10.1007/s12325-011-0052-y
    1. Gorfine S. R., Erol O., Patou G., Krivokapic Z. V. (2011). Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, dobule-blind, placebo-controlled trial. Dis. Colon Rectum 54 1552–1559 10.1097/DCR.0b013e318232d4c1
    1. Hall M. J., DeFrances C. J., Williams S. N., Golosinskiy A., Schwartzman A. (2010). National hospital discharge survey: 2007 summary. Natl. Health Stat. Report. 29:1–20 10.3886/ICPSR28162.v1
    1. Kehlet H., Dahl J. B. (2003). Anaesthesia, surgery, and challenges in postoperative recovery. Lancet 362 1921–1928 10.1016/S0140-6736(03)14966-5
    1. Kiuchi M. G., Zapata-Sudo G., Trachez M. M., Ririe D., Sudo R. T. (2011). The influence of age on bupivacaine cardiotoxicity. Anesth. Analg. 112 574–580 10.1213/ANE.0b013e31820a9178
    1. Kuthiala G., Chaudhary G. (2011). Ropivacaine: a review of its pharmacology and clinical use. Indian J. Anaesth. 55 104–110 10.4103/0019-5049.79875
    1. Lai J., Porreca F., Hunter J. C., Gold M. S. (2004). Voltage-gated sodium channels and hyperalgesia. Annu. Rev. Pharmacol. Toxicol. 44 371–397 10.1146/annurev.pharmtox.44.101802.121627
    1. Minkowitz S. H., Onel E., Patronella K. C., Smoot D. J. (2012). A two-year observational study assessing the safety of DepoFoam bupivacaine after augmentation mammaplasty. Aesthet. Surg. J. 32 186–193 10.1177/1090820X11434524
    1. Naseem A., Harada T., Wang D., Arezina R., Lorch U., Onel E., et al. (2012). Bupivacaine extended release liposome injection does not prolong QTc interval in a thorough QT/QTc study in healthy volunteers. J. Clin. Pharmacol. 52 1441–1447 10.1177/0091270011419853
    1. Nigam A. K., Taylor D. M., Valeyeva Z. (2011). Non-invasive interactive neurostimulation (InterXTM) reduces acute pain in patients following total knee treplacement surgery: a randomised, controlled trial. J. Orthop. Surg. Res. 6 45 10.1186/1749-799X-6-45
    1. Oda Y., Ikeda Y. (2013). Effect of lipid emulsion on the central nervous system and cardiac toxicity of bupivacaine and levobupivacaine in awake rats. J. Anesth. 27 500–504 10.1007/s00540-013-1581-0
    1. Pacella E., Collini S., Pacella F., Piraino D. C., Santamaria V, De Blasi R. A. (2010). Levobupivacaine vs. racemic bupivacaine in peribulbar anaesthesia: a randomized double blind study in ophthalmic surgery. Eur. Rev. Med. Pharmacol. Sci. 14 539–544
    1. Richard B. M., Rickert D. E., Newton P. E., Ott L. R., Haan D., Brubaker A. N., et al. (2011). Nelson. safety evaluation of EXPAREL (DepoFoam Bupivacaine) administered by repeated subcutaneous injection in rabbits and dogs: species comparison. J. Drug Deliv. 2011 1–14 10.1155/2011/467429
    1. Sakai N., Inoue T., Kunugiza Y., Tomita T., Mashimo T. (2013). Continuous femoral versus epidural block for attainment of 120° knee flexion after total knee arthroplasty: a randomized controlled trial. J. Arthroplasty 28 807–814 10.1016/j.arth.2012.09.013
    1. Smoot D. J., Sergio D. B., Onel R., Williams T. H., Hedden W. (2012). The efficacy and safety of DepoFoam bupivacaine in patients undergoing bilateral, cosmetic, submuscular, augmentation mammaplasty: a randomized, double-bind, active-control study. Aesthet. Surg. J. 32 69–76 10.1177/1090820X11430831
    1. Srinvivasa V., Gerner P., Haderer A., Abdi S., Jarolim P., Wang K. G. (2003). The relative toxicity of amitriptyline, bupivacaine, and levobupivacaine administered as rapid infusions in rats. Anesth. Analg. 97 91–95 10.1213/01.ANE.0000065600.15574.AB
    1. White P. F., Kehlet H. (2010). Improving postoperative pain management: What are the unresolved issues? Anesthesiology 112 220–225 10.1097/ALN.0b013e3181c6316e
    1. Yang S., Abrahams M. S., Hurn P. D., Grafe M. R., Kirsch J. R. (2011). Local anesthetic Schwann cell toxicity is time and concentration dependent. Reg. Anesth. Pain Med. 36 444–451 10.1097/AAP.0b013e318228c835

Source: PubMed

3
Subskrybuj