Regional 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 optimal condition and have an i.v. line inserted before the blocking procedure. The clinician responsible should take the necessary precautions to avoid intravascular injection (see Dosage & Administration) and be appropriately trained and familiar with diagnosis and treatment of side effects, systemic toxicity and other complications. (See Overdosage.)
Major peripheral nerve blocks may imply the administration of a large volume of local anaesthetic in highly vascularized areas, often close to large vessels where there is an increased risk of intravascular injection and/or rapid systemic absorption, which can lead to high plasma concentrations.
Certain local anaesthetic procedures such as injections in the head and neck regions may be associated with a higher frequency of serious adverse reactions, regardless of the local anaesthetic used.
Patients in poor general condition due to aging or other compromising factors such as partial or complete heart conduction block, advanced liver disease or severe renal dysfunction require special attention, although regional anaesthesia is frequently the optimal anaesthetic technique in these patients. Patients treated with anti-arrhythmic drugs class III (e.g. amiodarone) should be under close surveillance and consider ECG monitoring, since cardiac effects may be additive.
There have been rare reports of cardiac arrest during the use of Naropin for epidural anaesthesia or peripheral nerve blockade, especially after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease. In some instances, resuscitation has been difficult. Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the possibility of a successful outcome.
Ropivacaine is metabolised in the liver. It should therefore be used with caution in patients with severe liver disease and repeated doses may need to be reduced due to delayed elimination. Normally, there is no need to modify the dose in patients with impaired renal function when used for single dose or short-term treatment. Acidosis and reduced plasma protein concentration, frequently seen in patients with chronic renal failure may increase the risk of systemic toxicity.
Epidural anaesthesia may lead to hypotension and bradycardia. The risk of such effects can be reduced e.g. by preloading the circulation or by injecting a vasopressor. Hypotension should be treated promptly with for example ephedrine 5-10 mg intravenously, repeated as necessary.
Prolonged administration of ropivacaine should be avoided in patients treated with strong inhibitors of CYP1A2 such as fluvoxamine and enoxacin (see Interactions).
Naropin solution for injection and infusion is possibly with acute porphyria where no safer alternative is available. Appropriate precautions should be taken in the case of the vulnerable patients.
There have been post-marketing reports of chondrolysis in patients receiving post-operative intra-articular continuous infusion or local anesthetics. 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, casuality has not been established. Intra-articular continous infusion is not an approved indication for Naropin.
Effects on ability to drive and use machines: Besides the direct anaesthetic effect, local anaesthetics may have a very mild effect on mental function and coordination even in the absence of overt CNS toxicity and may temporarily impair locomotion and alertness.