• Afif Hadj, Andrew Hadj, Anthony Hadj, Frank Rosenfeldt, Douglas Nicholson, John Moodie, Richard Turner, Richard Watts, Ian Fletcher, Nacer Abrouk, and Dmitri Lissin.
• Department of Surgery, Maroondah Hospital, Melbourne, Australia. afifhadj@gmail.com
• ANZ J Surg. 2012 Apr 1;82(4):251-7.

BackgroundPain relief remains a major problem in hernia surgery. SABER-Bupivacaine is an investigational extended-release formulation of bupivacaine in a resorbable matrix, which may provide up to 72 h of local pain relief.MethodsA double-blinded, randomized controlled trial was undertaken to evaluate the safety and efficacy of SABER-Bupivacaine. Consented patients (n = 124) undergoing open inguinal hernia repair at five sites in Australia and New Zealand were randomized to receive either 2.5 (330 mg) or 5.0 mL (660 mg) of SABER-Bupivacaine or SABER-Placebo administered to the surgical wound at the end of the procedure. Analgesic efficacy and safety was evaluated.ResultsSABER-Bupivacaine appeared safe with no difference in the incidence of side effects compared with SABER-Placebo. The 5.0 mL dose of SABER-Bupivacaine reduced the mean area under the curve of pain intensity on movement compared with SABER-Placebo (2.47 versus 3.60; P = 0.0033) and decreased the number of patients requiring supplemental opioids by 26% (although not statistically significant; P = 0.0909). Normal wound healing was reported throughout the trial and at 3- and 6-month follow-up in every treatment group.ConclusionAfter open inguinal hernia repair, SABER-Bupivacaine administered at the surgical site was safe and provided pain relief, reduced the need for supplemental (oral and parenteral) analgesia and did not impair wound healing.© 2011 The Authors. ANZ Journal of Surgery © 2011 Royal Australasian College of Surgeons.

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