Bupivacaine

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Bupivacaine

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Bupivacaine can only be used by doctors who have experience with local anesthesia or under their supervision. To achieve the desired degree of anesthesia, you must enter the lowest possible dose.

Under no circumstances should accidental intravascular administration of the drug be allowed. Before and during the introduction of the drug is recommended to carry out an aspiration test. The drug must be administered slowly, at a rate of 25–50 mg / min or fractionally, maintaining continuous verbal contact with the patient and controlling the heart rate. During epidural administration, a dose of 3-5 ml of bupivacaine with epinephrine is pre-administered. In the case of accidental intravascular injection, a short-term increase in the heart rate occurs, and in case of accidental intrathecal administration, a spinal block arises. In the event of toxic signs, administration is stopped immediately.

Below are the approximate doses that need to be adjusted depending on the depth of anesthesia and the patient's condition.

Infiltration anesthesia: 5–60 ml of the drug at a concentration of 2.5 mg / ml (12.5–150 mg of bupivacaine) or 5–30 ml of the drug at a concentration of 5 mg / ml (25–150 mg of bupivacaine).

Diagnostic and therapeutic blockade: 1–40 ml of the drug in a concentration of 2.5 mg / ml (2.5–100 mg of bupivacaine), for example, the trigeminal nerve blockade 1–5 ml (2.5–12.5 mg) and the cervico-thoracic sympathetic trunk node 10–20 ml (25–50 mg).

Intercostal blockade: 2-3 ml of the drug at a concentration of 5 mg / ml (10-15 mg of bupivacaine) per nerve, not exceeding the total number - 10 nerves.

Large blockade (for example, epidural blockade, blockade of the sacral or brachial plexus): 15–30 ml of the drug at a concentration of 5 mg / ml, (75–150 mg of bupivacaine).

Anesthesia in obstetrics (for example, epidural and caudal anesthesia during vaginal delivery): 6–10 ml of the drug at a concentration of 2.5 mg / ml (15–25 mg of bupivacaine) or 6–10 ml of the drug at a concentration of 5 mg / ml (30–50 mg of bupivacaine ).

Every 2-3 hours repeated administration of the drug in the initial dose is allowed.

Epidural anesthesia for caesarean section: 15–30 ml of 5 mg / ml (75–150 mg of bupivacaine).

Epidural analgesia in the form of intermittent bolus: Initially, 20 ml of the drug is administered at a concentration of 2.5 mg / ml (50 mg of bupivacaine), then every 4–6 hours, depending on the number of damaged segments and the patient’s age, 6–16 ml of the drug at a concentration of 2.5 mg / ml ( 15–40 mg of bupivacaine).

Epidural analgesia as a continuous infusion (for example, postoperative pain):

	Concentration	Volume	Dose
Epidural (lumbar): Bolus1 Infusion	2.5 mg / ml 2.5 mg / ml	5–10 ml 5–7.5 ml / h	12.5-25 mg 12.5-18.75 mg2
Epidural (thoracic level): Bolus1 Infusion	2.5 mg / ml 2.5 mg / ml	5–10 ml 2.5–5 ml / h	12.5-25 mg 6.25–12.5 mg
Epidural (natural childbirth): Bolus1 Infusion	2.5 mg / ml 2.5 mg / ml	6–10 ml 2–5 ml / h	15-25 mg 5–12.5 mg

¹ If during the previous hour the drug was not injected bolus.

² Do not exceed the maximum recommended daily dose (see below).

During the course of surgery, additional administration of the drug is possible.

With simultaneous use of narcotic analgesics, the dose of bupivacaine should be reduced.

With prolonged administration of the drug in a patient, it is necessary to regularly monitor blood pressure, heart rate and other signs of potential toxicity. If toxic effects appear, the drug should be immediately discontinued.

Maximum recommended doses

The maximum recommended single dose, calculated at the rate of 2 mg / kg body weight, is 150 mg for adults for four hours. This is equivalent to 60 ml of the drug at a concentration of 2.5 mg / ml (150 mg of bupivacaine) and 30 ml of the drug at a concentration of 5 mg / ml (150 mg of bupivacaine).

The maximum recommended daily dose is 400 mg. However, when calculating the total daily dose, it is necessary to take into account the patient’s age, physique and other significant conditions.

Children aged 1–12 years

Regional anesthesia should be performed by a doctor who has experience in working with children and is familiar with the appropriate injection technique.

Doses in children listed in the table are indicative. Variability is possible. In children with high body weight, as a rule, it is necessary to reduce the dose, based on the ideal body weight. In determining the methods of anesthesia and taking into account the individual characteristics of patients should use the generally accepted guidelines for anesthesia.

The minimum dose needed to achieve sufficient anesthesia should be administered.

	Conc., Mg / ml	Volume ml / kg	Dose, mg / kg	Onset of action, min	Duration of action, min
Acute pain
Caudal epidural anesthesia	2,5	0,6–0,8	1,5–2	20–30	2–6
Lumbar Epidural Anesthesia	2,5	0,6–0,8	1,5–2	20–30	2–6
Thoracic epidural anesthesiab)	2,5	0,6–0,8	1,5–2	20–30	2–6

b) during thoracic epidural anesthesia, the drug is administered in increasing doses until the desired level of anesthesia is achieved.

The dose in children is calculated based on 2 mg / kg of body volume.

In order to prevent the drug from entering the bloodstream, an aspiration test should be carried out before and during the administration of the main dose. The drug should be administered slowly, dividing the total dose into several injections, especially with lumbar and thoracic epidural anesthesia, continuously monitoring the indicators of vital organs.

Peritonsillar infiltration anesthesia in children from 2 years: at a dose of 7.5 mg and 12.5 mg per tonsil at a bupivacaine concentration of 2.5 mg / ml.

Iliac / inguinal / ileal nerve blockade in children from 1 year: 0.1–0.5 ml / kg with a bupivacaine concentration of 2.5 mg / ml, which is equivalent to 0.25–1.25 mg / kg. Children aged 5 years and older may be given the drug at a concentration of 5 mg / ml at a dose of 1.25–2 mg / kg.

Blockade of the penis: 0.2–0.5 ml / kg at a concentration of 5 mg / ml, which corresponds to 1.25–2 mg / kg.

Data on epidural anesthesia in children (bolus or continuous administration) is limited.

Cooking method

If it is necessary to obtain a solution with a concentration of 2.5 mg / ml, the drug with a concentration of 5 mg / ml is diluted with water for injection in a 1: 1 ratio.

With intrathecal administration

Bupivacaine can only be used by doctors who have experience with local anesthesia or under their supervision. To achieve the desired degree of anesthesia, you must enter the lowest possible dose.

The doses listed below are adults. Selection of the dose is carried out individually.

Elderly patients and patients in late pregnancy dose should be reduced.

Indications for use	Dose, ml	Dose mg	Start of action	Duration of action
Surgery on the lower limbs, including operations on the hip joint	2–4 ml	10–20 mg	5–8 min	1.5–4 h

The recommended injection site is at L3 level.

There is no clinical experience with doses exceeding 20 mg. Intravenous access must be provided prior to the administration of the drug.

The introduction is carried out only after confirmation of the ingress into the subarachnoid space (the discharge of a clear cerebrospinal fluid from the needle or during aspiration). If an attempt is unsuccessful, only one additional attempt should be made at a different level and on a smaller scale. One of the reasons for the lack of effect can be a poor distribution of the drug in the subarachnoid space, which can be corrected by changing the position of the patient.

Children with body weight less than 40 kg

Bupivacaine, injection, 5 mg / ml, is allowed in children.

The main difference between adults and children is that in newborns and infants the volume of cerebrospinal fluid is larger, which requires a relatively higher dose per kg of body weight compared with adults to achieve the same degree of blockade.

Regional anesthesia should be performed by a doctor who has experience in working with children and is familiar with the appropriate injection technique.

Doses in children listed in the table are indicative. Variability is possible.In determining the methods of anesthesia and taking into account the individual characteristics of patients should use the generally accepted guidelines for anesthesia. The minimum dose needed to achieve sufficient anesthesia should be administered.

Body weight, kg	Dose, mg / kg
	0.4–0.5 mg / kg
5–15	0.3–0.4 mg / kg
15–40	0.25–0.3 mg / kg

With paracervical blockade in obstetrics, bupivacaine can cause severe cardiovascular disorders in the fetus. The use of bupivacaine as a means for paracervical blockade is contraindicated.

Use of the drug for the stated indications for use is possible if the expected benefit to the mother exceeds the possible risk to the fetus.

Bupivacaine penetrates into breast milk, but when used in therapeutic doses, the effect on the baby is insignificant.

With intrathecal administration

No data on adverse effects on pregnancy are available. When used in pregnant animals in high doses, a decrease in the survival of the offspring in rats and embryological effects in rabbits were found.In this regard, bupivacaine should not be used in early pregnancy, unless the benefits do not exceed the risks.

In late pregnancy should reduce the dose. Bupivacaine penetrates into breast milk, but when used in therapeutic doses, the effect on the baby is insignificant.

The introduction of local anesthetics should be carried out in the immediate vicinity of resuscitation equipment. Before the start of large blockades, it is necessary to ensure venous access.

There are reports of cardiac arrest or death during the use of bupivacaine for epidural anesthesia or peripheral blockade. In some cases, resuscitation was difficult or impossible, despite adequate treatment.

The blockade of the main peripheral nerves may require the introduction of large amounts of local anesthetics in well-circulating areas of the body, often near large blood vessels. In such situations, the risk of intravascular bupivacaine or systemic absorption increases, which can lead to high concentrations of local anesthetic in the blood.

Like other local anesthetics, bupivacaine can cause acute toxic reactions from the central nervous and cardiovascular systems, if during the procedure of local anesthesia its high concentration in the blood occurs. This is most often manifested in the case of inadvertent intravascular injection or with good blood supply to the site of administration.

Certain types of local anesthesia, regardless of the local anesthetic used, may cause the development of serious adverse reactions, for example:

· Epidural anesthesia, especially against the background of hypovolemia, can lead to inhibition of the cardiovascular system. Care must be taken in patients with diseases of the cardiovascular system.

· In case of retrobulbar administration, the drug can occasionally penetrate into the cranial subarachnoid space, causing temporary blindness, apnea, convulsions, collapse and other undesirable reactions. The reduction of these reactions must be carried out immediately.

· When retrobulbar and peribulbar injection of local anesthetics, there is a certain risk of persistent dysfunction of the eye muscles. The main causes are trauma and (or) local toxic effects on muscles and (or) nerves.

· With an unintended intravascular injection in the head and neck, even at low doses, it can cause cerebral symptoms.

The severity of the undesirable reactions described above depends on the size of the injury, the concentration of the local anesthetic and the duration of its effect on the tissue. Therefore, as with other local anesthetics, it is necessary to administer the lowest effective dose of bupivacaine.

Caution should be exercised in patients with AV-blockade grade II or III, since local anesthetics may interfere with intracardiac conduction. Care must be taken when administering the drug to the elderly and patients with severe liver disease, severe renal insufficiency, or a generally unsatisfactory condition.

It is necessary to carry out careful observation and continuous ECG monitoring in patients receiving class III antiarrhythmic drugs (eg, amiodarone), since their cardiovascular toxic effects can be summed with those of bupivacaine.

When conducting epidural anesthesia, a decrease in blood pressure and bradycardia may occur. It is possible to reduce the likelihood of such complications by pre-injection of crystalloid and colloid solutions. With a decrease in blood pressure, immediate intravenous administration of sympathomimetics (for example, 5-10 mg ephedrine) is indicated; if necessary, their introduction is repeated.

According to the post-registration observation, in some patients who, after a long-term operation, were administered local anesthetics into the articular cavity, chondrolysis occurred. In most cases, chondrolysis of the shoulder joint. The causal relationship with the introduction of bupivacaine is not fully confirmed, perhaps, chondrolysis is due to several factors. The literature describes conflicting data on the mechanism of the occurrence of this state. Prolonged intraarticular administration is not an approved indication for bupivacaine.

The solution does not contain preservatives, so it must be immediately introduced after opening the bottle. The remains of the solution to be destroyed.

Children

The safety and efficacy of bupivacaine in children under 1 year of age have not been studied, only limited data are available.

Data on the intra-articular blockade of bupivacaine in children 1–12 years old are not available.

Data on the blockade of bupivacaine major nerves in children 1–12 years old are not available.

With epidural anesthesia, the drug should be administered slowly, guided by age and body weight, since especially with epidural anesthesia at the chest level severe hypotension and respiratory failure can occur.

With intrathecal administration

Spinal anesthesia can cause severe blockade and paralysis of the intercostal muscles and diaphragm, especially in pregnant women.

Elderly patients and patients in late pregnancy have an increased risk of high or complete spinal block, leading to inhibition of blood circulation and respiration. In these patients, reduce the dose.

Spinal anesthesia can lead to lower blood pressure and bradycardia. This risk can be reduced by the introduction of crystalloid solutions. With a decrease in blood pressure, it should be stopped immediately, for example, by intravenous administration of 5-15 mg ephedrine.

In patients with hypovolemia, regardless of its cause, a sudden severe decrease in blood pressure may develop during intrathecal anesthesia.

Spinal anesthesia can cause intercostal paralysis, and therefore, patients with pleural effusion may experience respiratory failure. Septicemia may increase the risk of intraspinal abscess formation in the postoperative period.

Neurological complications are a rare consequence of spinal anesthesia and can lead to paresthesia, anesthesia, muscle weakness and paralysis. In some cases, these complications are permanent.

Before treatment, the benefits and risks for the patient should be correlated.

Influence on ability to drive vehicles and work with mechanisms

Depending on the dose and route of administration, local anesthetics may have a transient effect on motor function and coordination of movements.

Acute systemic toxicity

Symptoms

Toxic reactions are manifested mainly by the central nervous and cardiovascular systems. They occur due to the high concentration of local anesthetic in the blood, which may be due to accidental intravascular administration, overdose, or extremely rapid absorption from highly vascularized tissues (see the section "Special Instructions").

The signs of CNS damage for all local amide-type anesthetics are similar to each other, whereas the symptoms of the cardiovascular system are different, both qualitatively and quantitatively.

Inadvertent intravascular administration of a local anesthetic can lead to immediate systemic toxic reactions (within a few seconds to a few minutes). Signs of systemic toxicity in overdose appear later (15–60 min after administration), as the concentration of local anesthetic in the blood increases slowly.

CNS intoxication appears gradually, the severity of the symptoms of which increases gradually. The initial signs are usually dizziness, paresthesias around the mouth, numbness of the tongue, hyperacusis, tinnitus and visual disturbances. More serious manifestations are dysarthria and myofasciculations, which may precede the onset of generalized diseases.