title: Safety and efficacy of extended-release bupivacaine local anaesthetic in open hernia repair: a randomized controlled trial.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Surgery, Maroondah Hospital, Melbourne, Australia. afifhadj@gmail.com
authors.forename: Afif
authors.initials: A
authors.lastname: Hadj
authors.forename: Andrew
authors.initials: A
authors.lastname: Hadj
authors.forename: Anthony
authors.initials: A
authors.lastname: Hadj
authors.forename: Frank
authors.initials: F
authors.lastname: Rosenfeldt
authors.forename: Douglas
authors.initials: D
authors.lastname: Nicholson
authors.forename: John
authors.initials: J
authors.lastname: Moodie
authors.forename: Richard
authors.initials: R
authors.lastname: Turner
authors.forename: Richard
authors.initials: R
authors.lastname: Watts
authors.forename: Ian
authors.initials: I
authors.lastname: Fletcher
authors.forename: Nacer
authors.initials: N
authors.lastname: Abrouk
authors.forename: Dmitri
authors.initials: D
authors.lastname: Lissin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000768:Anesthesia, General; D000779:Anesthetics, Local / Q000008:administration & dosage* / Q000009:adverse effects; D002045:Bupivacaine / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006552:Hernia, Inguinal / Q000601:surgery*; D059685:Herniorrhaphy / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000517:prevention & control; D055815:Young Adult
chemical_list: D000779:Anesthetics, Local; D003692:Delayed-Action Preparations; D002045:Bupivacaine