Efeito da metadona intravenosa comparado ao da morfina na qualidade de recuperação anestésica após cirurgia de gastroplastia videolaparoscópica: ensaio clínico prospectivo, randomizado e controlado
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2021-08-16
Autores
Pontes, João Paulo Jordão
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Universidade Estadual Paulista (Unesp)
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Introdução e objetivos: a gastroplastia é a terapia mais eficaz para o tratamento da obesidade mórbida ou complicada e tem sido cada vez mais realizada. Entretanto, apesar da evolução da técnica cirúrgica, até 42% dos pacientes experimentam dor importante no pós-operatório o que é reconhecido como fator de risco para desenvolvimento de dor crônica. A estratégia de analgesia baseada em opioides de curta duração, como a morfina, proporciona níveis plasmáticos flutuantes que podem ser insuficientes ou excessivos a ponto de causar depressão respiratória. Neste contexto, a metadona aparece como alternativa atraente durante o período precoce de maior intensidade de dor, uma vez que garante concentração plasmática estável, meia-vida de até 36 horas e baixo risco de depressão respiratória. O objetivo desse ensaio clínico foi avaliar o efeito da metadona intravenosa intraoperatória sobre a qualidade de recuperação pós-operatória comparada à morfina em gastroplastia videolaparoscópica. Métodos: conduzimos estudo prospectivo, paralelo, randomizado, duplo-cego e controlado em pacientes obesos submetidos à gastroplastia videolaparoscópica sob anestesia geral. Cento e quarenta pacientes foram randomizados, dos quais 3 foram excluídos, e alocados em dois grupos: grupo Morfina (n=68) e grupo Metadona (n=69), os quais receberam no intraoperatório 0,1 mg/kg de morfina ou metadona a depender do grupo. O desfecho primário foi a qualidade de recuperação pós-operatória avaliada por meio do escore global do questionário Quality of Recovery-40 (QoR-40) 24 horas após a cirurgia, enquanto os desfechos secundários foram avaliados na sala de recuperação anestésica (SRPA), na noite da cirurgia (T1), manhã seguinte à cirurgia (T2) e noite seguinte à cirurgia (T3). Três meses após a cirurgia, os pacientes foram avaliados quanto à qualidade de vida relacionada à saúde por meio do questionário Short Form Health Survey – 36 (SF-36). Resultados: a mediana (IQR [amplitude]) do escore global do QoR-40 no grupo Metadona foi 194 (190-197[165-200]) sendo significativamente maior quando comparada à do grupo Morfina que foi de 181 (174-185,5 [121-200]) (p<0,0001). Na SRPA, a carga de dor foi menor no grupo Metadona totalizando 120 (15-255 [0-795]) quando comparada ao grupo Morfina que registrou 446,25 (315-592,5 [75-1222,5]) (p<0,0001), assim como a incidência de náuseas e vômitos, respectivamente 22% vs 33% (p=0,046) e 2,8% vs 14,7% (p=0,014), e o consumo cumulativo de opioide resgate 2(0-6 [0-14]) vs 10(6-12 [0-18]) (p<0,0001). Durante internação em enfermaria, o uso de opioides resgate foi menor no grupo metadona quando comparado ao grupo morfina em T1, 5,8% vs 54,4% (p<0,0001), e T2, 0% vs 20,1% (p<0,0001), da mesma forma que a incidência de náuseas também foi menor no grupo metadona 21,7% vs 41,2% (p=0,014). Observamos correlação inversa significativa entre o consumo cumulativo de opioide resgate e os escores globais do QoR-40 (rho = -0,64; p<0,0001). A avaliação de qualidade de vida 3 meses após a cirurgia não mostrou diferença significativa entre os grupos, apesar de análise secundária mostrar que os pacientes que tiveram melhores escores no subcomponente de dor do QoR-40, apresentaram maiores escores globais do SF-36. Conclusão: a metadona intravenosa intraoperatória melhora a qualidade de recuperação pós-operatória nos pacientes submetidos a cirurgia bariátrica laparoscópica comparada à morfina, além de reduzir a dor pós-operatória, o consumo de opioides e a incidência de eventos adversos.
Background and objectives: gastroplasty is the most effective therapy for the treatment of morbid or complicated obesity and has been increasingly performed. However, despite the evolution of the surgical technique, up to 42% of patients experience significant pain in the postoperative period, which is recognized as a risk factor for the development of chronic pain. The analgesia strategy based on short-acting opioids, such as morphine, provides fluctuating plasma levels that may be insufficient or excessive to the point of causing respiratory depression. In this context, methadone appears as an attractive alternative during the early period when pain intensity is the greatest, as it guarantees stable plasma concentration, a half-life of up to 36 hours and a low risk of respiratory depression. The objective of this clinical trial was to evaluate the effect of intraoperative intravenous methadone on the quality of postoperative recovery compared to morphine in videolaparoscopic gastroplasty. Methods: we conducted a prospective, parallel, randomized, double-blinded, controlled study in obese patients undergoing videolaparoscopic gastroplasty under general anaesthesia. One hundred and forty patients were randomized, of which 3 were excluded, and allocated into two groups: morphine group (n=68) and methadone group (n=69), who received intraoperatively 0.1 mg/kg of morphine or methadone depending on the group. The primary outcome was the quality of postoperative recovery assessed using the global score of the Quality of Recovery-40 (QoR-40) questionnaire 24 hours after surgery, while the secondary outcomes were assessed in the post-anaesthesia care unit (PACU) on the night of surgery (T1), morning after surgery (T2) and night after surgery (T3). Three months after surgery, patients were assessed for health-related quality of life using the Short Form Health Survey – 36 (SF-36). Results: The median (IQR [range]) total QoR-40 score of 194 (190-197 [165-200]) was higher (p<0.0001) in the methadone group compared to the score of 181 (174-185.5 [121-200]) in the morphine group. In the PACU, the pain burden was lower in the Methadone group, totalling 120 (15-255 [0-795]) when compared to the Morphine group, which recorded 446.25 (315-592.5 [75-1222.5]) (p <0.0001), as well as the incidence of nausea and vomiting, respectively 22% vs 33% (p=0.046) and 2.8% vs 14.7% (p=0.014), and the cumulative consumption of rescue opioid 2 (0-6 [0-14]) vs 10(6-12 [0-18]) (p<0.0001). During hospitalization in the ward, the use of rescue opioids was lower in the methadone group when compared to the morphine group at T1, 5.8% vs 54.4% (p<0.0001), and T2, 0% vs 20.1% (p<0.0001), just as the incidence of nausea was also lower in the methadone group 21.7% vs 41.2% (p=0.014). We observed a significant inverse correlation between cumulative rescue opioid consumption and global QoR-40 scores (rho= -0.64; p<0.0001). Quality of life assessment 3 months after surgery showed no significant difference between groups, although secondary analysis showed that patients who had better scores in the QoR-40 pain subcomponent had higher SF-36 global scores. Conclusion: intra-operative intravenous methadone improved quality of recovery in patients who underwent laparoscopic gastroplasty, compared to intra-operative morphine. Methadone also reduced: postoperative pain; postoperative opioid consumption; and the incidence of opioid-related adverse events.
Background and objectives: gastroplasty is the most effective therapy for the treatment of morbid or complicated obesity and has been increasingly performed. However, despite the evolution of the surgical technique, up to 42% of patients experience significant pain in the postoperative period, which is recognized as a risk factor for the development of chronic pain. The analgesia strategy based on short-acting opioids, such as morphine, provides fluctuating plasma levels that may be insufficient or excessive to the point of causing respiratory depression. In this context, methadone appears as an attractive alternative during the early period when pain intensity is the greatest, as it guarantees stable plasma concentration, a half-life of up to 36 hours and a low risk of respiratory depression. The objective of this clinical trial was to evaluate the effect of intraoperative intravenous methadone on the quality of postoperative recovery compared to morphine in videolaparoscopic gastroplasty. Methods: we conducted a prospective, parallel, randomized, double-blinded, controlled study in obese patients undergoing videolaparoscopic gastroplasty under general anaesthesia. One hundred and forty patients were randomized, of which 3 were excluded, and allocated into two groups: morphine group (n=68) and methadone group (n=69), who received intraoperatively 0.1 mg/kg of morphine or methadone depending on the group. The primary outcome was the quality of postoperative recovery assessed using the global score of the Quality of Recovery-40 (QoR-40) questionnaire 24 hours after surgery, while the secondary outcomes were assessed in the post-anaesthesia care unit (PACU) on the night of surgery (T1), morning after surgery (T2) and night after surgery (T3). Three months after surgery, patients were assessed for health-related quality of life using the Short Form Health Survey – 36 (SF-36). Results: The median (IQR [range]) total QoR-40 score of 194 (190-197 [165-200]) was higher (p<0.0001) in the methadone group compared to the score of 181 (174-185.5 [121-200]) in the morphine group. In the PACU, the pain burden was lower in the Methadone group, totalling 120 (15-255 [0-795]) when compared to the Morphine group, which recorded 446.25 (315-592.5 [75-1222.5]) (p <0.0001), as well as the incidence of nausea and vomiting, respectively 22% vs 33% (p=0.046) and 2.8% vs 14.7% (p=0.014), and the cumulative consumption of rescue opioid 2 (0-6 [0-14]) vs 10(6-12 [0-18]) (p<0.0001). During hospitalization in the ward, the use of rescue opioids was lower in the methadone group when compared to the morphine group at T1, 5.8% vs 54.4% (p<0.0001), and T2, 0% vs 20.1% (p<0.0001), just as the incidence of nausea was also lower in the methadone group 21.7% vs 41.2% (p=0.014). We observed a significant inverse correlation between cumulative rescue opioid consumption and global QoR-40 scores (rho= -0.64; p<0.0001). Quality of life assessment 3 months after surgery showed no significant difference between groups, although secondary analysis showed that patients who had better scores in the QoR-40 pain subcomponent had higher SF-36 global scores. Conclusion: intra-operative intravenous methadone improved quality of recovery in patients who underwent laparoscopic gastroplasty, compared to intra-operative morphine. Methadone also reduced: postoperative pain; postoperative opioid consumption; and the incidence of opioid-related adverse events.
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Palavras-chave
Gastroplastia, Obesidade mórbida, Metadona, Morfina, Medidas de Resultados Relatados pelo Paciente, Gastroplasty, Methadone, Morphine, Morbid obesity, patient reported outcome measures