L-Ascain Special Precautions



Dexa Medica


Averroes Pharma
Full Prescribing Info
Special Precautions
In performing levobupivacaine blocks, unintended intravenous injection is possible and may result in cardiac arrest (some cases fatal). Despite rapid detection and appropriate treatment, prolonged resuscitation may be required. The resuscitability relative to bupivacaine is unknown at this point in time as it has not been studied. As with all local anesthetics of the amide-type, levobupivacaine should be administered in incremental doses. Cases of severe bradycardia, hypotension, and respiratory compromise with cardiac arrest (some of them fatal), have been reported in conjunction with local anesthetics, including levobupivacaine. Since levobupivacaine should not be injected rapidly in large doses, it is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary.
Historically, pregnant patients were reported to have a high risk for cardiac arrhythmias, cardiac/circulatory arrest and death when bupivacaine was inadvertently rapidly injected intravenously. For Caesarean section, the 5 mg/ml (0.5%) levobupivacaine solution in doses up to 150 mg is recommended.
Local anesthetics should only be administered by clinicians who are well versed in the diagnosis and management of drug-related toxicity and other acute emergencies which might arise from the block being administered. The immediate availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies must be ensured. Delay in proper management of drug-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest, and possibly death.
When contemplating a peripheral nerve block, where large volumes of local anesthetic are needed, caution should be exercised when using the higher mg/ml concentrations of levobupivacaine.
The safe and effective use of local anesthetics depends on proper dosage, correct technique, adequate precautions, and readiness for emergencies.
Resuscitative equipment, oxygen, and resuscitative drugs should be available for immediate use (see Adverse Reactions). The lowest dosage that results in effective anesthesia should be used to avoid high plasma or dermatomal levels and serious adverse effects. Injections should be made slowly and incrementally, with frequent aspirations before and during the injection to avoid intravascular injection. When a continuous catheter technique is used, syringe aspirations should also be performed before and during each supplemental injection. During the administration of epidural anesthesia, it is recommended that a test dose of a local anesthetic with a fast onset be administered initially and that the patient be monitored for central nervous system and cardiovascular toxicity, as well as for signs of unintended intrathecal administration before proceeding. When clinical conditions permit, consideration should be given to employing local anesthetic solutions that contain epinephrine for the test dose because circulatory changes compatible with epinephrine may also serve as a warning sign of unintended intravascular injection. An intravascular injection is still possible even if aspirations for blood are negative.
Systemic adverse reactions following overdose for accidental intravascular injection reported with long acting local anesthetic agents involve both CNS and cardiovascular effects.
Levobupivacaine should be used with caution in conditions associated with impaired cardiovascular functions.
Injection of repeated doses of local anesthetics may cause significant increases in plasma levels with each repeated dose due to slow accumulation of the drug or its metabolites or to slow metabolic degradation. Tolerance to elevated blood levels varies with the physical condition of the patient. Local anesthetics should also be used with caution in patients with hypotension, hypovolemia, or impaired cardiovascular function, especially heart block.
Careful and constant monitoring of cardiovascular and respiratory vital signs (adequacy of ventilation) and the patient's state of consciousness should be performed after each local anesthectic injection. The clinician must be aware that restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early signs of central nervous system toxicity.
Amide-type local anesthetics, such as levobupivacaine, are metabolized by the liver, therefore, these drugs especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk for developingtoxic plasma concentrations. Local anesthetics should also be used with caution in patients with impaired cardiovascular function as they may be less able to compensate for functional changes associated with prolonged A-V conduction caused by these drugs.
Many drugs used during the conduct of anesthesia are considered potential triggering agents for malignant hyperthermia. Amide-type local anesthetics are not known to trigger this reaction.
Epidural anesthesia: During epidural anesthesia, levobupivacaine should be administered in incremental volumes of three to five milliliters (3 to 5 ml), with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Syringe aspirations should also be performed before and during each supplemental injection in continuous catheter techniques. An intravascular injection is still possible even if aspirations are negative. During the administration of epidural anesthesia, it is recommended that a test dose is administered initially and the effects monitored before the full dose is given. A test dose of a short-acting amide anesthetic, such as three milliliters (3 ml) of lidocaine, is recommended to detect unintentional intrathecal administration. This will be manifested within a few minutes by signs of a subarachnoid block (e.g., decreased sensation of the buttocks, paresis of the legs or, in the sedated patient, absent knee jerk). Unintentional intrathecal injection of local anesthetics can lead to very high spinal anesthesia, possibly apnea, severe hypotension and loss of consciousness. An intravascular or intrathecal injection is still possible, even if the results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, extensive subarachnoid block, or cardiovascular effects.
Epidural analgesia: There have been postmarketing reports of cauda equina syndrome and events indicative of neurotoxicity temporally associated with the use of levobupivacaine for greater than or equal to 24 hours for epidural analgesia. These events were more severe and, in some cases, led to permanent sequelae when levobupivacaine was administered for greater than 24 hours. Therefore, the use of levobupivacaine is not recommended for more than 24 hours.
It is essential that aspiration for blood or cerebrospinal fluid (where applicable) be done prior to injecting any local anesthetic, both before the original dose and all subsequent doses, to avoid intravascular or intrathecal injection. However, a negative aspiration does not ensure against intravascular or intrathecal injection. Levobupivacaine should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive.
Use in head and neck area: Small doses of local anesthetics injected into the head and neck area may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. The injection procedures require the utmost care. Confusion, convulsions, respiratory depression, and/or respiratory arrest and cardiovascular stimulation or depression have been reported. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their respirations and circulation monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded.
Information for the patient: When appropriate, patients should be informed in advance that they may experience temporary loss of sensation and motor activity in the anesthetized part of the body following correct administration of the regional anesthesia. Also, when appropriate, the physician should discuss other information including adverse reactions in the levobupivacaine package insert.
Effects on Ability to Drive and Use Machines: Levobupivacaine can have a major influence on the ability to drive or use machines. Patients should be warned not to drive or operate machinery until all the effects of the anesthesia and the immediate effects of surgery are passed.
Use in the Elderly: No overall differences in safety and effectiveness between geriatric patients and younger patients. Greater sensitivity of some older individuals cannot be rulled out.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in