Sergivell Plain/Sergivell Iso Special Precautions

Like all local anesthetics, bupivacaine may cause acute toxicity effects on the central nervous and cardiovascular systems if utilized for local anesthetic 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.
Adequate resuscitation equipment should be available whenever local or general anesthesia is administered. The clinician responsible should take the necessary precautions to avoid intravascular injection. Before any nerve block is attempted, intravenous access for resuscitation purposes should be established. Clinicians should have received adequate and appropriate training in the procedure to be performed and should be familiar with the diagnosis and treatment of side effects, systemic toxicity, or other complications.
Patients treated with anti-arrhythmic agents class III (e.g. amiodarone) should be under close surveillance and ECG monitoring, since cardiac effects may be additive.
The physiological effects generated by a central neural blockade are more pronounced in the presence of hypotension. Patients with hypovolemia due to any cause can develop sudden and severe hypotension during epidural anesthesia.
Effects on ability to drive and use machines: Bupivacaine hydrochloride has a minor influence on the ability to drive and use machines. Besides the direct anesthetic effect, local anesthetics 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.
Sergivell Plain: Intrathecal anaesthesia should only be undertaken by clinicians with the necessary knowledge and experience.
Should cardiac arrest occur, a successful outcome may require prolonged resuscitative efforts. High systemic concentrations are not expected with doses normally used for intrathecal anesthesia.
There is an increased risk of high or total spinal blockade, resulting in cardiovascular and respiratory depression, in the elderly and in patients in the late stages of pregnancy. The dose should therefore be reduced in these patients.
Intrathecal anaesthesia with any local anaesthetic can cause hypotension and bradycardia which should be anticipated and appropriate precautions taken. These may include preloading the circulation with crystalloid or colloid solution. If hypotension develops it should be treated with a vasopressor such as ephedrine 10-15 mg intravenously. Severe hypotension may result from hypovolaemia due to haemorrhage or dehydration, or aorto-caval occlusion in patients with massive ascites, large abdominal tumours or late pregnancy. Marked hypotension should be avoided in patients with cardiac decompensation.
Patients with hypovolaemia due to any cause can develop sudden and severe hypotension during intrathecal anaesthesia.
Intrathecal anaesthesia can cause intercostal paralysis and patients with pleural effusions may suffer respiratory embarrassment. Septicaemia can increase the risk of intraspinal abscess formation in the postoperative period.
Neurological injury is a rare consequence of intrathecal anaesthesia and may result in paraesthesia, anaesthesia, motor weakness and paralysis. Occasionally these are permanent.
Before treatment is instituted, consideration should be taken if the benefits outweigh the possible risks for the patient.
Patients in poor general condition due to ageing or other compromising factors such as partial or complete heart conduction block, advanced liver or renal dysfunction require special attention, although regional anaesthesia may be the optimal choice for surgery in these patients.
Sergivell Iso: There have been reports of cardiac arrest or death during the use of bupivacaine for epidural anesthesia or peripheral nerve blockade, we despite apparently adequate preparation and appropriate management.
Major peripheral nerve blocks may require the administration of a large volume of local anesthetic in highly vascularised areas and/or areas with a higher risk of systemic absorption which may lead to increased plasma concentration of the medicine.
Overdosage or accidental intravenous injection may give rise to toxic reactions.
Injection of repeated doses of bupivacaine hydrochloride may cause significant increases in blood levels with each repeated dose due to the slow accumulation of the drug. Tolerance varies with the status of the patient. Although regional anesthesia is frequently considered an optimal anesthetic technique, some patients require special attention in order to reduce the risk of serious side effects: The elderly and patients in poor general condition should be given reduced doses commensurate with their physical status.
Patients with partial or complete heart block due to the fact that local anesthetics may depress myocardial conduction.
Patients with advanced liver disease and severe renal dysfunction.
Patients in the late stages of pregnancy.
Patients allergic to ester-type local anesthetic drugs (procaine, tetracaine, benzocaine, etc.) have not shown cross-sensitivity to agents of the amide type such as bupivacaine.
Certain local anesthetic procedures may be associated with serious adverse reactions, regardless of the local anesthetics used.
Local anesthetics should be used with caution for epidural anesthesia in patients with impaired cardiovascular function since they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs.
Epidural anesthesia should therefore be avoided or used with caution in patients with untreated hypovolemia or significantly impaired venous return. Retrobulbar injections may very rarely the cranial subarachnoid space causing temporary blindness, cardiovascular collapse, apnoea, convulsions, etc.
Retro-and perbulbar injections of local anesthetic may cause 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 issue reaction is related to the degree of trauma, the concentration of the local anesthetic, and the duration of exposure of the tissue to the local anesthetic. For this reason, as with all local anesthetics, the lowest effective concentration and dose of local anesthetic should be used.
Vasoconstrictors may aggravate tissue reactions and should be used only when indicated.
Small doses of local anesthetics injected into the head and neck, including retrobulbar dental and stellate ganglion blocks, may produce systemic toxicity due to inadvertent intra-arterial injection.
Paracervical block may have a greater adverse effect on the fetus than other nerve blocks used in obstetrics. Due to the systemic toxicity of bupivacaine special care should be taken when using bupivacaine for paracervical block.
There have been post-marketing reports of chondrolysis in patients receiving post-operative intraarticular continuous infusion of 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 the mechanism of this action, causality has not been established. Intraarticular continuous infusion is not an approved indication for Bupivacaine hydrochloride (Sergivell iso).
Epidural anesthesia with any local anesthetic can cause hypotension and bradycardia which should be anticipated and appropriate precautions are taken. The risk of such effects can be reduced, e.g. by injection of vasopressor agents.
Hypotension should be managed urgently by intravenous administration of sympathomimetic, repeated as necessary Severe hypotension may result from hypovolemia due to hemorrhage or dehydration, or aortocaval occlusion in patients with massive ascites, large abdominal tumors, or late pregnancy. Marked hypotension should be avoided in patients with cardiac decompensation.
Patients with hypovolaemia due to any cause can develop sudden and severe hypotension during epidural anesthesia.
Epidural anesthesia can cause intercostal paralysis and patients with pleural effusions may suffer respiratory embarrassment. Septicemia can increase the risk of intraspinal abscess formation in the postoperative period.
When bupivacaine is administered as an intraarticular injection, caution is advised when recent major intra-articular trauma is suspected or extensive raw surfaces within the joint have been created by the surgical procedure, as that may accelerate the absorption and result in higher plasma concentrations of the anesthetic.
Use in Children: Safety and efficacy of this medicine in children aged up to 1 year have not been established. Only limited data are available.
The use of bupivacaine for intraarticular block in children 1 to 12 years of age has not been documented.
The use of bupivacaine for major nerve blocks in children 1 to 12 years of age has not been documented.
Epidural anesthesia in children should be given by gradual doses corresponding with their age and body weight as especially epidural anesthesia at the thoracic route may result in severe hypotension and respiratory impairment.