Comparison of the effect of adding midazolam versus fentanyl to intrathecal levobupivacaine in patients undergoing cesarean section: double-blind, randomized clinical trial
Comparação do efeito da adição de midazolam versus fentanil à levobupivacaína intratecal em pacientes submetidas a cesariana: ensaio clínico randomizado, duplo-cego
Marwa Mahmoud Abdelrady, Golnar Mohammed Fathy, Mohamed Abdelrady Mohamed Abdallah, Wesam Nashat Ali
Abstract
Background: Many adjuvants are added to prolong the effects of spinal analgesia. We investigated the postoperative analgesic efficacy of the addition of midazolam or fentanyl to intrathecal levobupivacaine in women undergoing cesarean delivery.
Methods: Eighty patients were randomly assigned to two groups (n = 40). Group M received 10 mg of 0.5% levobupivacaine plus 2 mg of midazolam. Group F received 10 mg of 0.5% levobupivacaine plus 25 μg of fentanyl. Assessments included motor and sensory block, APGAR score, time to first request for analgesia, postoperative pain score, total consumption of rescue analgesics, and adverse effects.
Results: Sensory blockade was prolonged in Group M compared with Group F (215.58 ± 27.94 vs. 199.43 ± 19.77 min; p = 0.004), with no differences in other characteristics of the spinal block in intraoperative hemodynamics or APGAR score. The mean time to first request for rescue analgesia was longer in Group M (351.45 ± 11.05 min) than in Group F (268.83 ± 10.35 min; p = 0.000). The median total consumption of rescue analgesics in the first 24 hours postoperatively was 30 mg in Group M vs. 60 mg in Group F (p = 0.003). The median Visual Analog Scale (VAS) scores were lower in Group Ethan in Group F from the 8th to the 12th hour postoperatively, with no differences between the groups at other time points. The incidence of adverse effects was higher in Group F than in Group M.
Conclusion: Intrathecal midazolam (2 mg) was superior to intrathecal fentanyl (25 μg) in increasing the duration of the sensory blockade and postoperative analgesia with lower postoperative pain scores and decreasing the incidence of adverse effects.
Keywords
Resumo
Introdução
Muitos adjuvantes são adicionados para prolongar os efeitos da analgesia espinhal. Nós investigamos a eficácia analgésica pós-operatória da adição de midazolam ou fentanil à levobupivacaína intratecal em mulheres submetidas a parto cesáreo.
Métodos
Oitenta pacientes foram distribuídas aleatoriamente em dois grupos (n = 40). O Grupo M recebeu 10 mg de levobupivacaína a 0,5% mais 2 mg de midazolam. O Grupo F recebeu 10 mg de levobupivacaína a 0,5% mais 25 μg de fentanil. As avaliações incluíram bloqueio motor e sensorial, índice de APGAR, tempo até a primeira solicitação de analgesia, índice de dor pós-operatória, consumo total de analgésicos de resgate e efeitos adversos.
Resultados
O bloqueio sensorial foi prolongado no Grupo M em comparação ao Grupo F (215,58 ± 27,94 vs. 199,43 ± 19,77 min; p = 0,004), sem diferenças em outras características da raquianestesia na hemodinâmica intraoperatória ou no escore APGAR. O tempo médio até a primeira solicitação de analgesia de resgate foi maior no Grupo M (351,45 ± 11,05 min) do que no Grupo F (268,83 ± 10,35 min; p = 0,000). A mediana do consumo total de analgésicos de resgate nas primeiras 24 horas de pós-operatório foi de 30 mg no Grupo M vs. 60 mg no Grupo F (p = 0,003). As medianas dos escores da Escala Visual Analógica (EVA) foram menores no Grupo Ethan e no Grupo F da 8ª à 12ª hora de pós-operatório, sem diferenças entre os grupos nos demais momentos. A incidência de efeitos adversos foi maior no Grupo F do que no Grupo M.
Conclusão
O midazolam intratecal (2 mg) foi superior ao fentanil intratecal (25 μg) no aumento da duração do bloqueio sensorial e da analgesia pós-operatória, com menores escores de dor pós-operatória e na diminuição da incidência de efeitos adversos.
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References
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Submitted date:
11/10/2020
Accepted date:
06/01/2022
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