There have been reports of cardiac arrest or death during use of bupivacaine for epidural anaesthesia or peripheral nerve blockade. In some instances, resuscitation has been difficult or impossible despite apparently adequate preparation and management.
Like all local anaesthetic drugs, bupivacaine may cause acute toxicity effects on the central nervous and cardiovascular systems, if utilised for local anaesthetic procedures resulting in high blood concentrations of the drug. This is especially the case after unintentional intravascular administration or injection into highly vascular areas. Ventricular arrhythmia, ventricular fibrillation, sudden cardiovascular collapse and death have been reported in connection with high systemic concentrations of bupivacaine.
Regional or local anaesthetic procedures should always be performed in a properly equipped and staffed area. Equipment and drugs necessary for monitoring and emergency resuscitation should be immediately available.
Patients receiving major blocks, should be in an optimal condition and have an i.v. line inserted before the blocking procedure. The clinician responsible should take the necessary precautions to avoid overdose or intravascular injection, always including careful aspiration (See Dosage & Administration), and be appropriately trained and familiar with the diagnosis and treatment of side effects, systemic toxicity and other complications such as marked restlessness, twitching or convulsions followed by coma with apnoea and cardiovascular collapse (See Adverse Reactions & Overdosage).
Major peripheral nerve blocks may imply the administration of a large volume of local anaesthetic in areas of high vascularity, often close to large vessels where there is an increased risk of intravascular injection and/or systemic absorption which can lead to high plasma concentrations.
Although regional anaesthesia is frequently the optimal anaesthetic technique, some patients require special attention in order to reduce the risk of dangerous side effects: The elderly and patients in poor general condition.
Patients with partial or complete heart block - due to the fact that local anaesthetics may depress myocardial conduction.
Patients with advanced liver disease or severe renal dysfunction.
Patients in late stages of pregnancy.
Patients treated with anti-arrhythmic drugs class III (e.g. amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive.
Certain local anaesthetic procedures may be associated with serious adverse reactions, regardless of the local anaesthetic drug used.
Central nerve blocks may cause cardiovascular depression, especially in the presence of hypovolaemia and therefore epidural anaesthesia should be used with caution in patients with impaired cardiovascular function.
Retrobulbar injections may very occasionally reach the cranial subarachnoid space causing temporary blindness, cardiovascular collapse, apnoea, convulsions etc.
Retro- and peribulbar injections of local anaesthetics carry a low risk of persistent ocular muscle dysfunction. The primary causes include trauma and/or local toxic effects on muscles and/or nerves.
The severity of such tissue reactions is related to the degree of trauma, the concentration of the local anaesthetic and the duration of exposure of the tissue to the local anaesthetic. For this reason, as with all local anaesthetics, the lowest effective concentration and dose of local anaesthetic should be used. Vasoconstrictors may aggravate tissue reactions and should be used only when indicated. Injections in the head and neck regions may be made inadvertently into an artery may cause immediate cerebral symptoms even at low doses.
Paracervical block can sometimes cause foetal bradycardia/tachycardia, and careful monitoring of the foetal heart rate is necessary.
There have been reports of chondrolysis in patients receiving post-operative intra-articular continuous infusion of local anaesthetics. The majority of reported cases of chondrolysis have involved the shoulder joint. Due to multiple contributing factors and inconsistency in the scientific literature regarding mechanism of action, causality has not been established. Intra-articular continuous infusion is not an approved indication for Marcain.
Epidural anaesthesia may lead to hypotension and bradycardia. The risk of such effects can be reduced, e.g. by injecting a vasopressor. Hypotension should be treated promptly with a sympathomimetic intravenously, repeated as necessary.
The lowest dose that produces effective anaesthesia should be used. Injection of repeated doses of bupivacaine hydrochloride may cause significant increases in blood levels with each repeated dose due to slow accumulation of the drug. Tolerance varies with the status of the patient. Debilitated, elderly or acutely ill patients should be given reduced doses commensurate with their physical status. The continuous or repeated administration of this product may give rise to cumulative toxicity and tachyphylaxis (See Adverse Reactions).
Bupivacaine hydrochloride should be used with caution in patients with epilepsy, impaired cardiac conduction or in those with hepatic or renal damage.
Marcain solutions should be used with caution in persons with known drug sensitivities. Patients allergic to ester-type local anaesthetic drugs (procaine, tetracaine, benzocaine, etc) have not shown cross-sensitivity to agents of the amide type such as bupivacaine.
Since bupivacaine is metabolised in the liver, it should be used cautiously in patients with liver disease or with reduced liver blood flow (e.g. in severe shock).
Effects on ability to drive and use machines: Depending on dosage, local anaesthetics may have a very mild effect on mental function and may temporarily impair locomotion and co-ordination. Patients should not drive or use machinery until complete recovery from these effects has occurred.