Safety and Efficacy of IntraOsseous Ropivacaine in Lower Extremity (SORE) Study

The aim of the study is to evaluate delivery of intraosseous (IO) regional ropivacaine in lower limb surgery (anterior cruciate ligament reconstruction) and, determine the safety (and efficacy) of two different doses in reducing perioperative pain. Compared to high volume local anaesthesia (HVLA) or peripheral nerve blocks which can sometimes be incomplete and lack the necessary coverage of the extremity, a Bier’s block procedure of the lower limb is a reliable and predictable means for intraoperative analgesia during ACL reconstruction surgery. The use of intraosseous ropivacaine with an inflated tourniquet may reduce intraoperative analgesia and result in prolonged immediate postoperative analgesia. During the time of tourniquet inflation, local anaesthesia disperses into the surrounding soft tissue (from IO to IV then subsequent soft tissue). Greater concentrations of anaesthesia achieved in the soft tissue at tourniquet deflation means longer times until complete clearance of the medication and therefore prolonged anaesthesia. This reduces the unexpected need for rescue analgesia including opioids whose side effect profile can impair patient recovery through nausea and vomiting, sedation, constipation and respiratory depression.