BUPIVACAINE

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BUPIVACAINE
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MEDICAL INFORMATIONS

INDICATIONS

  • Epidural anesthesia: Epidural anesthesia, whether by caudal or lumbar route, is effective in the neonate. Typical doses of bupivacaine 0.125% to 0.25% are 1.25 mg/kg to 2.5 mg/kg for caudal epidural anesthesia , 2 mg/kg up to a maximum of 2.5 mg/kg for epidural anesthesia (other than caudal route) , and 0.2 mg/kg/hr up to a maximum of 0.25 mg/kg/hr for continuous epidural infusion for a maximum duration of 24 to 36 hours . Data are lacking in premature infants. Although, one study used 3.125 mg/kg of 0.5% bupivacaine by the caudal route as an adjunct to general anesthesia in 20 premature infants (0 to 60 days; 520 to 2750 grams). No neonate experienced elevated heart rate or blood pressure at the time of incision . In a retrospective analysis of 750 children (2 days to 16 years of age), bupivacaine 0.25% provided longer postoperative pain relief (up to 5 hours) than lidocaine 0.5% or 1.5% when administered caudally
  • Peripheral nerve block:
  • For neonatal circumcision a dorsal nerve block with a local anesthetic is recommended . A penile nerve block is appropriate for urethral dilation and hypospadias repair. Solutions containing epinephrine should NOT be used near end-artery areas (eg, digits, nose, external ear, penis) or areas of compromised blood supply . Efficacy data are lacking in neonates; however, in 2 pharmacokinetic studies bupivacaine nerve blocks were used in neonates without associated toxic concentrations or observed adverse events. Doses of bupivacaine were 2 mg/kg for interpleural nerve block in 8 very low birthweight infants (700 g to 1022 g) and 1.5 mg/kg for intercostal block in 11 full-term neonates (1 to 27 days of age).
  • Spinal Anesthesia: The use of spinal anesthesia is common in neonates, even preterm infants. In comparison to adults, the dose is greater in neonates . Dose range is 0.5 to 1 mg/kg with usual doses of 0.6 mg/kg of 0.75% hyperbaric bupivacaine in 8.25% dextrose and 0.8 mg/kg of 0.5% isobaric bupivacaine . The duration of effective spinal blockade (lack of hip flexion) was 84+/-16 minutes in 11 infants (range: 0.1 to 7 months of age; 2.8 to 9.3 kg) who received 0.75% bupivacaine 0.6 mg/kg in 8.25% dextrose solution with 0.02 mL of 1:1000 epinephrine . Efficacy data are lacking in premature infants.

FDA APPROVED INDICATION

Indicated for the production of local or regional anesthesia or analgesia for surgical procedures, dental and oral surgery procedures, and diagnostic and therapeutic procedures. Use is not recommended in pediatric patients younger than 12 years. Marcaine™ Spinal: Indicated for production of subarachnoid block (spinal anesthesia). Use in patients younger than 18 years is not recommended.

INDICATIONS

  • Arrhythmias (eg, complete heart block) which severely restrict cardiac output (spinal injection)
  • Hypersensitivity to bupivacaine, to other amide-type anesthetics, or to any component of the product
  • Local infection at the site of proposed lumbar puncture (spinal injection)
  • Obstetrical paracervical block anesthesia
  • Septicemia (spinal injection)
  • Severe hemorrhage (spinal injection)
  • Severe hypotension (spinal injection)
  • Shock (spinal injection)

PRECAUTIONS

  • Administration:
    • Avoid intravascular injection; use proper technique (spinal injection).
    • Do not use solutions containing antimicrobial preservatives (eg, multipledose vials) for epidural or caudal anesthesia.
    • Risk of significant increase in plasma concentrations with repeated local administration.
    • Head and neck area administration has been associated with events that occur with systemic toxicity (convulsion, confusion, respiratory depression and/or respiratory arrest, and cardiovascular stimulation or depression); monitoring recommended.
    • Upper airway obstruction, requiring intubation; pulmonary edema; and tachydysrhythmia may occur with inadvertent vagal blockade in patients undergoing glossopharyngeal nerve block with bupivacaine for pain relief after tonsillectomy. Vocal cord paralysis is a potential complication when bupivacaine is infiltrated in the peritonsillar region.
  • Cardiovascular:
    • Cardiac arrest and death have been reported when used for IV regional anesthesia (Bier Block); not recommended.
    • Cardiac arrest, death, and other dose-related toxicity and acute emergencies may occur; proper medical management required (spinal injection).
    • Serious dose-related arrhythmias may occur with use of bupivacaine in combination with vasoconstrictors such as epinephrine during or after use of potent inhalation anesthetics.
    • Use caution in patients with a history of cardiac rhythm disturbances, shock, heart block, or hypotension.
    • Risk of reduced ability to compensate for functional changes associated with AV conduction prolongation in patients with cardiovascular impairment.
    • Blood-flow restriction in end-artery areas (eg, digits, nose, external ear, penis) or areas of compromised blood supply may occur when bupivacaine is used in combination with vasoconstrictors; increased risk in patients with a history of hypertensive vascular disease due to an exaggerated vasoconstrictor response; ischemic injury or necrosis may occur.
  • Concomitant Use:
    • Concomitant use of monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants should be avoided; if concomitant use is required, administer with extreme caution; may increase risk of severe prolonged hypertension when bupivacaine is in combination with epinephrine or other vasopressors.
    • Concomitant use of ergot-type oxytocic agents should be avoided when bupivacaine is in combination with epinephrine or other vasopressors.
    • Mixing or the prior or concurrent use of any other local anesthetic is not recommended (spinal injection).
  • Endocrine & Metabolic:
    • Familial malignant hyperthermia may be triggered by anesthetics.
  • Hematologic:
    • Methemoglobinemia has been reported with use of local anesthetics; increased risk in patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites and other drugs associated with methemoglobinemia; if use is required in at-risk patients monitoring is recommended; medical management and discontinuation of therapy is required.
  • Hepatic:
    • Increased risk of developing toxic plasma concentrations in patients with severe hepatic disease, especially with repeat doses.
  • Immunologic:
    • Some bupivacaine with epinephrine solutions contain sodium metabisulfite; patients with sulfite sensitivity may experience allergic-type reactions including anaphylaxis.
  • Muskuloskeletal:
    • Chondrolysis has been reported with postoperative intra-articular infusions of local anesthetics (unapproved use).
  • Renal:
    • Impairment of renal function may increase risk of toxic reactions; monitoring recommended.
  • Reproductive:
    • Spinal anesthetics should not used during uterine contractions (spinal injection).
  • Respiratory:
    • Acidosis, death, and other dose-related toxicity and acute emergencies may occur; proper medical management required (spinal injection).
  • Special Population:
    • Debilitated and acutely ill patients may have lower tolerance to elevated blood levels; dose adjustment recommended

ADVERSE EFFECTS

As with other amide-type local anesthetics, adverse effects are related to excessive concentrations due to overdosage, inadvertent intravascular injection, or slow metabolism of bupivacaine. These adverse events are serious, typically dose-related, and generally affect the central nervous and cardiovascular system. Central nervous system reactions include restlessness, anxiety, dizziness, tinnitus, blurred vision, tremors, convulsions, drowsiness leading to unconsciousness and respiratory depression, nausea, vomiting, chills, and miosis. Cardiovascular reactions include depression of myocardium, decreased cardiac output, heartblock, hypotension, bradycardia, ventricular arrhythmias (ventricular tachycardia and ventricular fibrillation), and cardiac arrest. Rare allergic reactions may occur. Risks with epidural and spinal anesthesia or nerve blocks near the vertebral column include underventilation or apnea with inadvertent subarachnoid injection; and hypotension secondary to loss of sympathetic tone and respiratory paralysis or underventilation when motor blockade extends cephaladly. Other risks of epidural and spinal anesthesia include urinary retention, fecal and urinary incontinence, loss of perineal sensation, persistent anesthesia, paraesthesia, weakness, paralysis of the lower extremities and loss of sphincter control, headache, backache, septic meningitis, meningismus, and cranial nerve palsies due to traction on nerves from loss of cerebrospinal fluid. Risk of other routes of anesthesia include persistent anesthesia, paresthesia, weakness, paralysis, all of which may have slow, incomplete, or no recovery . In pharmacokinetic studies, no adverse events were reported in 11 neonates following intercostal nerve block with bupivacaine , 8 very low birthweight infants following interpleural nerve block with bupivacaine , or 20 newborns (including 18 premature neonates) administered spinal anesthesia with bupivacaine.

BLACK BOX WARNING

The 0.75% concentration of bupivacaine injection is not recommended for obstetrical anesthesia. Cardiac arrest with difficult resuscitation or death during use of bupivacaine for epidural anesthesia in obstetrical patients has been reported. In most cases, this has followed use of the 0.75% concentration. Cardiac arrest has occurred after convulsions resulting from systemic toxicity, presumably following unintentional intravascular injection. The 0.75% concentration should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary.

ADMINISTRATION

Bupivacaine is NOT recommended for intravenous regional anesthesia (Bier Block).

  • Epidural anesthesia: Use only single-dose ampules and single-dose vials for caudal or epidural anesthesia as multiple dose vials contain a preservative. Administer slowly in 3- to 5- mL incremental doses with sufficient time between doses to detect signs/symptoms of unintentional intravascular or intrathecal injection. Perform syringe aspirations before and during each supplemental injection in continuous (intermittent) catheter techniques. Administer a test dose, which contains epinephrine, and monitor the effects prior to the full dose and with all subsequent doses when a catheter is in place. The use of a local anesthetic in the test dose is probably unwarranted and may lead to toxicity. Avoid rapid injection of large volumes of anesthetic solutions. When possible, use fractional (incremental) doses.
  • Local infiltration and peripheral nerve blocks: Check aspiration for blood or cerebrospinal fluid (when applicable) prior to injecting any local anesthetic, both initial and subsequent doses. Avoid rapid injection of large volumes of anesthetic solutions. When possible, use fractional (incremental) doses.

MONITORING

Carefully monitor cardiovascular (including circulation) and respiratory vital signs and neurological status continuously during and after each injection, including during retrobulbar, dental, and stellate ganglion blocks. Continuously monitor for level of pain control, using an appropriate pain assessment tool. Monitor for signs and symptoms of methemoglobinemia. In general, monitoring bupivacaine concentrations is not warranted; however, when there is a concern for accumulation then it may be appropriate. Consider monitoring concentrations when a local anesthesia is administered by continuous infusion at doses greater than 0.5 mg/kg/hr.

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