Levobupivacaína versus bupivacaína em anestesia peridural para cesarianas: estudo comparativo  <span class="so-article-trans-title" dir="auto"> Translated title: Levobupivacaine versus bupivacaine in epidural anesthesia for cesarean section: comparative study </span> <span class="so-article-trans-title" dir="auto"> Translated title: Levobupivacaína versus bupivacaína en anestesia peridural para cesáreas: estudio comparativo </span>

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Abstract

JUSTIFICATIVA E OBJETIVOS: O anestésico local bupivacaína é encontrado na forma de dois enantiômeros: levobupivacaína - S (-) e dextrobupivacaína - R (+). Baseado em estudos que demonstram que a cardiotoxicidade é menor com o enantiômero S(-), foi difundido o uso deste agente na prática clínica. Este estudo teve por objetivo comparar a eficácia e a efetividade do uso de bupivacaína racêmica com levobupivacaína em anestesia peridural de pacientes submetidas à cesariana eletiva. MÉTODO: Ensaio clínico aleatório, duplamente encoberto, com gestantes estado físico ASA I e II. As pacientes foram alocadas para receber 20 mL de bupivacaína a 0,5% racêmica ou 20 mL de levobupivacaína a 0,5%, ambas com 10 µg de sufentanil e vasoconstritor. RESULTADOS: Participaram do estudo 47 pacientes, 24 no grupo da levobupivacaína e 23 no grupo da bupivacaína. Os grupos eram comparáveis entre si quanto às características materno-fetais. Decorridos 15 minutos após o término da punção peridural, 62,5% das pacientes do grupo da levobupivacaína tinham Bromage 2 ou 3 versus 72,7% no grupo da bupivacaína (p = 0,83). Aos 20 minutos, 66,7% das pacientes do grupo da levobupivacaína tinham Bromage 2 ou 3 versus 86,3% do grupo da bupivacaína (p = 0,21). A complicação mais freqüente foi a hipotensão arterial, encontrada em 16 (66,7%) pacientes do grupo da levobupivacaína e em 10 (43,5%) pacientes do grupo da bupivacaína (p = 0,11). CONCLUSÕES: A levobupivacaína e a bupivacaína foram igualmente efetivas no bloqueio peridural de pacientes submetidas à cesariana.

Translated abstract

BACKGROUND AND OBJECTIVES: Local anesthetic bupivacaine is found in two different enantiomers: levobupivacaine - S (-) and dextrobupivacaine - R (+). Based on studies showing that S(-) enantiomers are less cardiotoxic, their use has been increasing in clinical practice. This study aimed at comparing racemic bupivacaine and levobupivacaine in epidural anesthesia for elective cesarean section. METHODS: Randomized, double blind clinical trial enrolling physical status ASA I and II parturients. Patients were assigned to receive either 20 mL of 0.5% racemic bupivacaine or 20 mL of 0.5% levobupivacaine, both with 10 µg sufentanil and epinephrine 1:200,000. RESULTS: Participated in this study 47 patients being 24 in the levobupivacaine group and 23 in the bupivacaine group. Both groups were comparable regarding maternal-fetal characteristics. Fifteen minutes after epidural anesthesia, 62.5% of levobupivacaine group patients experienced Bromage 2 or 3 motor block, whereas the same event was documented in 72.7% of bupivacaine group patients (p = 0.83). After 20 minutes, 66.7% of levobupivacaine group patients experienced Bromage 2 or 3 motor block versus 86.3% of bupivacaine group patients (p = 0.21). Most common complication was hypotension, detected in 16 (66.7%) levobupivacaine group patients and in 10 (43.5%) bupivacaine group patients (p = 0.11). CONCLUSIONS: Levobupivacaine and bupivacaine were equally effective for epidural block in patients undergoing cesarean section.

Translated abstract

JUSTIFICATIVA Y OBJETIVOS: El anestésico local bupivacaína es encontrado en la forma de dos enantiómeros: levobupivacaína - S (-) y dextrobupivacaína - R (+). Basado en estudios que demuestran que la cardiotoxicidad es menor con el enantiómero S(-), fue difundido el uso de este agente en la práctica clínica. El objetivo de este estudio es comparar la eficacia y la efectividad del uso de bupivacaína racémica con levobupivacaína en anestesia peridural de pacientes sometidas a cesárea electiva. MÉTODO: Ensayo clínico eventual, doblemente encubierto, con gestantes estado físico ASA I y II. Las pacientes fueron distribuidas para recibir 20 mL de bupivacaína a 0,5% racémica ó 20 mL de levobupivacaína a 0,5%, ambas con 10 µg de sufentanil y vasoconstrictor. RESULTADOS: Participaron del estudio 47 pacientes, 24 en el grupo de la levobupivacaína y 23 en el grupo de la bupivacaína. Los grupos eran comparables entre sí en lo que se refiere a las características materno-fetales. Transcurridos 15 minutos después del término de la punción peridural, 62,5% de las pacientes del grupo de la levobupivacaína tenían Bromage 2 ó 3 contra 72,7% en el grupo de la bupivacaína (p = 0,83). Transcurridos veinte minutos, 66,7% de las pacientes del grupo de la levobupivacaína tenían Bromage 2 ó 3 contra 86,3% del grupo de la bupivacaína (p = 0,21). La complicación más frecuente fue la hipotensión arterial, encontrada en 16 (66,7%) pacientes del grupo de la levobupivacaína y en 10 (43,5%) pacientes del grupo de la bupivacaína (p = 0,11). CONCLUSIONES: La levobupivacaína y la bupivacaína fueron igualmente efectivas en el bloqueo peridural de pacientes sometidas a cesárea.

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Most cited references 28

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Levobupivacaine: a review of its pharmacology and use as a local anaesthetic.

Kevin R. Foster, A. Catherine Markham (2000)

Based on findings that the cardiotoxicity infrequently observed with racemic bupivacaine shows enantioselectivity, i.e. it is more pronounced with the R(+)-enantiomer, the S(-)-enantiomer (levobupivacaine) has been developed for clinical use as a long acting local anaesthetic. The majority of in vitro, in vivo and human pharmacodynamic studies of nerve block indicate that levobupivacaine has similar potency to bupivacaine. However, levobupivacaine had a lower risk of cardiovascular and CNS toxicity than bupivacaine in animal studies. In human volunteers, levobupivacaine had less of a negative inotropic effect and, at intravenous doses >75 mg, produced less prolongation of the QTc interval than bupivacaine. Fewer changes indicative of CNS depression on EEG were evident with levobupivacaine. Levobupivacaine is long acting with a dose-dependent duration of anaesthesia. The onset of action is < or = 15 minutes with various anaesthetic techniques. In studies of surgical anaesthesia in adults, levobupivacaine provided sensory block for up to 9 hours after epidural administration of < or = 202.5 mg, 6.5 hours after intrathecal 15 mg, and 17 hours after brachial plexus block with 2 mg/kg. Randomised, double-blind clinical studies established that the anaesthetic and/or analgesic effects of levobupivacaine were largely similar to those of bupivacaine at the same dose. Sensory block tended to be longer with levobupivacaine than bupivacaine, amounting to a difference of 23 to 45 minutes with epidural administration and approximately 2 hours with peripheral nerve block. With epidural administration, levobupivacaine produced less prolonged motor block than sensory block. This differential was not seen with peripheral nerve block. Conditions satisfactory for surgery and good pain management were achieved by use of local infiltration or peribulbar administration of levobupivacaine. Levobupivacaine was generally as effective as bupivacaine for pain management during labour, and was effective for the management of postoperative pain, especially when combined with clonidine, morphine or fentanyl. The tolerability profiles of levobupivacaine and bupivacaine were very similar in clinical trials. No clinically significant ECG abnormalities or serious CNS events occurred with the doses used. The most common adverse event associated with levobupivacaine treatment was hypotension (31%). Levobupivacaine is a long acting local anaesthetic with a clinical profile closely resembling that of bupivacaine. However, current preclinical safety and toxicity data show an advantage for levobupivacaine over bupivacaine. Clinical data comparing levobupivacaine with ropivacaine are needed before the role of the drug can be fully established. Excluding pharmacoeconomic considerations, levobupivacaine is an appropriate choice for use in place of bupivacaine.

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Comparison of the effects of intrathecal ropivacaine, levobupivacaine, and bupivacaine for Caesarean section.

P Gautier, B Vanderick, Martha M Kock … (2003)

This study aimed to detect if intrathecal (i.t.) ropivacaine and levobupivacaine provided anaesthesia (satisfactory analgesia and muscular relaxation) and postoperative analgesia of similar quality to bupivacaine in patients undergoing Caesarean section. Ninety parturients were enrolled. A combined spinal-epidural technique was used. Patients were randomly assigned to receive one of the following isobaric i.t. solutions: bupivacaine 8 mg (n=30), levobupivacaine 8 mg (n=30), or ropivacaine 12 mg (n=30), all combined with sufentanil 2.5 microg. An i.t. solution was considered effective if an upper sensory level to pinprick of T4 or above was achieved and if intraoperative epidural supplementation was not required. Sensory changes and motor changes were recorded. Anaesthesia was effective in 97, 80, and 87% of patients in the bupivacaine 8 mg, levobupivacaine 8 mg, and ropivacaine 12 mg groups, respectively. Bupivacaine 8 mg was associated with a significantly superior success rate to that observed in the levobupivacaine group (P<0.05). It also provided a longer duration of analgesia and motor block (P<0.05 vs levobupivacaine and ropivacaine). The racemic mixture of bupivacaine combined with sufentanil remains an appropriate choice when performing Caesarean sections under spinal anaesthesia.