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Chirocaine for local or regional anesthesia

Brand Name: Chirocaine
Active Ingredient: levobupivacaine
Indication: Chirocaine induces local or regional anesthesia for surgery and obstetrics. It is also indicated for post-operative pain management.
Company Name: Purdue Pharma L.P.
Availability: Approved for marketing in the US on 5 August 1999

ChirocaineIntroduction

The active ingredient in Chirocaine (levobupivacaine) is an enantiomer of buvipacaine, a long-acting anesthetic. Currently, buvipacaine is the most commonly used local anesthetic in obstetrics; however, it is associated with potentially fatal cardiotoxicity. Clinical studies have shown that the risk of cardiotoxicity is not as great with Chirocaine. Chirocaine (levobupivacaine) is indicated for local or regional anesthesia in surgery and for post-operative pain management. More specifically, Chirocaine is to be used as surgical anesthesia for epidurals, peripheral neural blockades, and local infiltration. Chirocaine (levobupivacaine) can be used to manage pain by continuous epidural infusion or intermittent epidural blockage, continuous or intermittent peripheral neural blockage, and local infiltration.

How It Works

Chirocaine (levobupivacaine) blocks the generation and conduction of nerve impulses through a mechanism shared with most local anesthetics. Chirocaine produces an anesthetic effect by increasing the threshold for electrical excitation in the nerve. This can be achieved by slowing the propagation of the nerve impulse and by reducing the rate of rise of the action potential.

Chirocaine for local or regional anesthesiaChirocaine (levobupivacaine): Clinical Study Results

Chirocaine (levobupivacaine) was studied as a local anesthetic in adults, as an epidural block in surgical patients, in peripheral neural blockade, and for post-operative pain control. Most of the published clinical data involved the use of Chirocaine as an epidural block for surgical patients. Two clinical studies examined Chirocaine (levobupivacaine) administered epidurally in patients undergoing cesarean section. A randomized, double-blind trial compared Chirocaine and bupivacaine, 0.50%, in 62 patients. The mean time to sensory block measured at T4 to T6 was 10 +/- 8 minutes and 6 +/- 4 minutes for Chirocaine and bupivacaine, respectively. The mean duration of sensory and motor block was 8 +/- 1 hours and 4 +/- 1 hours for Chirocaine and 7 +/- 1 and 4 +/- 1 hours for bupivacaine. Blocks adequate for surgery were attained in 94% of Chirocaine patients and 100% of bupivacaine patients. The second trial was bupivacaine-controlled and included 62 patients undergoing cesarean section. The mean time to onset of T4 to T6 sensory block was 10 +/- 7 minutes for Chirocaine (levobupivacaine) and 9 +/- 7 minutes for bupivacaine. Bilateral blocks adequate for surgery were achieved in 94% and 91% of Chirocaine and bupivacaine patients, respectively.

The epidural administration of Chirocaine (levobupivacaine) during labor and delivery was compared to bupivacaine in a randomized, double-blind trial. Intermittent injections of Chirocaine 0.25% or bupivacaine 0.25% via an epidural catheter were administered to 68 patients. The median duration of pain relief was 49 minutes for Chirocaine patients and 51 minutes for bupivacaine patients. Following the first top-up injections, 91% of Chirocaine patients and 90% of bupivacaine patients received relief from pain.

Epidural administration of Chirocaine (levobupivacaine) was examined in 85 patients undergoing lower limb or major abdominal surgery. This randomized, double-blind study compared Chirocaine 0.5% and 0.75% to bupivacaine. The mean time to onset of sensory block was 14 +/- 6 minutes for Chirocaine and 14 +/- 10 minutes for bupivacaine in abdominal surgery patients. The time to complete regression of the block was 551 +/- 88 minutes for Chirocaine patients and 506 +/- 71 minutes for bupivacaine patients.

What the Patient Should Know

Adverse events that occurred in patients treated with Chirocaine (levobupivacaine) were no different from those associated with other amide-type local anesthetics. The majority of these adverse events due to this class of drugs are related to excessive plasma drug levels as a result of overdose, unintentional intravascular injection, or slow metabolic breakdown. The most common adverse events were hypotension, nausea, fever, and vomiting. As with other anesthetics, the patient may experience transient loss of sensation and motor activity in the anesthetized part of the body after proper administration of regional anesthesia. Nursing mothers should be cautious, since most local anesthetics are distribute into human milk. Although the presence of Chirocaine in human milk has not been well studied, small amounts of Chirocaine (levobupivacaine) were detected in the pups of rats after the drug was administered to the nursing mother.

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