Back to Search
Start Over
Safety and efficacy of extended-release bupivacaine local anaesthetic in open hernia repair: a randomized controlled trial.
- Source :
-
ANZ Journal of Surgery . Apr2012, Vol. 82 Issue 4, p251-257. 7p. - Publication Year :
- 2012
-
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. 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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 14451433
- Volume :
- 82
- Issue :
- 4
- Database :
- Academic Search Index
- Journal :
- ANZ Journal of Surgery
- Publication Type :
- Academic Journal
- Accession number :
- 73554053
- Full Text :
- https://doi.org/10.1111/j.1445-2197.2011.05754.x