Safety and efficacy of extended-release bupivacaine local anaesthetic in open hernia repair: a randomized controlled trial

Background: Pain 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. Methods: A 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. Results: SABER‐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. Conclusion: After 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.