Ropivacaine

Applies to adults and children above 12 years of age. The smallest dose required to produce an effective block should be used. FULL §4.2 TABLE (concentration 2.0 mg/ml throughout): lumbar epidural bolus 10-20 ml (20-40 mg), onset 10-15 min, duration 0.5-1.5 h; intermittent top-up injections (e.g. labour pain management) 10-15 ml (20-30 mg) with a minimum interval of 30 minutes; continuous infusion for labour pain 6-10 ml/h (12-20 mg/h); continuous infusion for postoperative pain management 6-14 ml/h (12-28 mg/h); thoracic epidural continuous infusion for postoperative pain management 6-14 ml/h (12-28 mg/h); field block (e.g. minor nerve blocks and infiltration) 1-100 ml (2.0-200 mg), onset 1-5 min, duration 2-6 h; peripheral nerve block (femoral or interscalene) continuous infusion or intermittent injections 5-10 ml/h (10-20 mg/h). TEST DOSE: when a large dose is to be injected, a test dose of 3-5 ml lidocaine 2% with adrenaline 1:200,000 is recommended; inadvertent intravascular injection may be recognised by a temporary increase in heart rate and accidental intrathecal injection by signs of a spinal block. If toxic symptoms occur the infusion should be stopped immediately. RECOMMENDED POST-OPERATIVE TECHNIQUE (verbatim in substance): unless preoperatively instituted, an epidural block with ropivacaine 7.5 mg/ml is induced via an epidural catheter and analgesia is then maintained with ropivacaine 2 mg/ml infusion at 6-14 ml (12-28 mg) per hour. In clinical studies, an epidural infusion of ropivacaine 2 mg/ml alone or mixed with fentanyl 1-4 micrograms/ml was given for postoperative pain management for up to 72 hours (the combination improved pain relief but caused opioid side effects, and was investigated only with ropivacaine 2 mg/ml). For peripheral nerve blocks in clinical studies, femoral nerve block was established with 300 mg of ropivacaine 7.5 mg/ml and interscalene block with 225 mg of ropivacaine 7.5 mg/ml before surgery, with analgesia then maintained with ropivacaine 2 mg/ml at 10-20 mg per hour for 48 hours. IMPORTANT SOURCE LIMITATION: the fetched SPC is for the 2 mg/ml (0.2%) SOLUTION FOR INFUSION. It does not contain the full surgical-anaesthesia dose tables for the more concentrated ropivacaine strengths (7.5 mg/ml and 10 mg/ml), which appear only as passing references above — re-source the relevant SPC if surgical anaesthesia dosing is required. Ropivacaine should only be used by, or under the supervision of, clinicians experienced in regional anaesthesia. PROVENANCE NOTE: the interactions listed come from the UK SPC §4.4 (class III antiarrhythmics, cross-referenced to §4.5) plus the US label section 7 (openFDA), because no UK SPC §4.5 was present in the fetched bundle.

SPC §4.2 paediatric table (0 up to and including 12 years of age; all figures at a concentration of 2.0 mg/ml). SINGLE CAUDAL EPIDURAL BLOCK, blocks below T12 in children with a body weight up to 25 kg: 1 ml/kg = 2 mg/kg. CONTINUOUS EPIDURAL INFUSION in children with a body weight up to 25 kg — 0 up to 6 months: bolus 0.5-1 ml/kg (1-2 mg/kg) then infusion up to 72 hours at 0.1 ml/kg/h (0.2 mg/kg/HOUR); 6 up to 12 months: bolus 0.5-1 ml/kg (1-2 mg/kg) then infusion up to 72 hours at 0.2 ml/kg/h (0.4 mg/kg/HOUR); 1 to 12 years: bolus 1 ml/kg (2 mg/kg, recommended for lumbar epidural blocks) then infusion up to 72 hours at 0.2 ml/kg/h (0.4 mg/kg/HOUR). Doses at the low end of the bolus intervals are recommended for thoracic epidural blocks and doses at the high end for lumbar or caudal epidural blocks; it is good practice to reduce the bolus dose for thoracic epidural analgesia. PERIPHERAL NERVE BLOCK, infants and children aged 1-12 years: single injections (e.g. ilioinguinal nerve block, brachial plexus block) should NOT exceed 2.5-3.0 mg/kg; continuous infusion is recommended at 0.2-0.6 mg/kg/h (0.1-0.3 ml/kg/h) up to 72 hours. In children with a high body weight a gradual reduction of the dosage is often necessary and should be based on ideal body weight. In children above 4 years of age, doses up to 3 mg/kg of a 3 mg/ml concentration have been studied, but this concentration is associated with a higher incidence of motor block. Fractionation of the calculated local anaesthetic dose is recommended, whatever the route of administration. More conservative doses and close monitoring are recommended for children with severe disease. The use of ropivacaine in premature children has not been documented. Verify all under-18 dosing against a children's formulary before administration.