None listed
Conditions
Brief summary
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.
Interventions
Name of intervention: Intraosseous ropivacaine
Patients undergoing primary anterior cruciate ligament reconstruction will be randomly assigned to one of two intervention groups.
Group 1: 1.5 mg/kg ropivacaine
Group 2: 2.0 mg/kg ropivacaine
Study medications for each group will be made up to 140ml aliquots and will be prepared by trained medical staff prior to administration. A tourniquet will be inflated on the upper thigh before the study medication is delivered by the operating surgeon int
Name of intervention: Intraosseous ropivacaine Patients undergoing primary anterior cruciate ligament reconstruction will be randomly assigned to one of two intervention groups. Group 1: 1.5 mg/kg ropivacaine Group 2: 2.0 mg/kg ropivacaine Study medications for each group will be made up to 140ml aliquots and will be prepared by trained medical staff prior to administration. A tourniquet will be inflated on the upper thigh before the study medication is delivered by the operating surgeon into bone via a proximal tibial cannula and immediately prior to skin incision. There is no need to assess or monitor patient fidelity as they will be under the effect of general anaesthesia when they receive the intervention.
Sponsors
Simon Young
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients undergoing anterior cruciate ligament (ACL) reconstruction would be eligible to participate in this prospective trial.
Exclusion criteria
Sensitivity or known allergy to ropivacaine Sensitivity or known allergy to intralipid Significant cardiac history Known epilepsy or history of seizures Precluded from having general anaesthesia Spinal anaesthesia or peripheral nerve block Severe hepatic disease Lower limbs not amenable to effective tourniquet use Hypertension (Systolic BP > 180mmHg)
Outcome results
None listed