Inkk Trial – Intraoperative ketamine for perioperative pain management following total knee endoprosthetic replacement in oncology: a double-blinded randomized trial
Inkk Trial – Cetamina intraoperatória para controle da dor perioperatória após substituição total da endoprótese do joelho em oncologia: um estudo randomizado duplo-cego
V. Susan Paulin; Sumitra Bakshi; Prateek C. Hegde; Akansha Rathod; Ashish Gulia; Ajeeta M. Kulkarni; Vincent S. Paramanandam
Abstract
Background
There has been a growing interest in the use of ketamine following orthopedic surgeries. We hypothesized that low dose intravenous ketamine during surgery would help in mobilization following total knee replacement (TKR) in oncology patients as assessed by the timed to up and go (TUG) test at 72 hours post-surgery. Our secondary objectives were to compare the opioid requirement at end of 72 hours, pain scores, satisfaction with pain management, adverse effects, range of joint movement achieved in the post-operative period and the functional recovery at the end of 1 month.
Methods
After ethics approval, registration of the trial with CTRI, and informed consent, this double-blinded trial was conducted. Using computer generated randomization charts, an independent team randomized the patients into ketamine group which received at induction, a ketamine bolus dose of 0.5 mg.kg-1 before the incision followed by 10 µg.kg-1. min-1 infusion which was maintained intraoperatively till skin closure and the saline group received an equivalent volume of saline. Postoperatively, patient controlled morphine pumps were given and the pain score with morphine usage were recorded for 72 hours. The TUG tests and range of motion were asessed by the physiotherapists until 72 hours.
Results
Fifty-two patients were enrolled in the trial. Demographics were comparable. No significant intraoperative hemodynamic changes and post-operative adverse were noted between the groups. A decrease in the TUG test, along with decreased opioid usage with a better range of movements, was noted in the ketamine group, but this was not statistically significant. Day of discharge, patient satisfaction score, and functional recovery assessed by Oxford Knee Score (OKS) were comparable between the groups.
Conclusion
In conclusion, low dose intraoperative ketamine infusion does not provide clinical benefit in perioperative pain management and postoperative rehabilitation following total knee endoprosthetic replacement in oncology.
Keywords
Resumo
Introdução
Houve um interesse crescente no uso de cetamina após cirurgias ortopédicas. Nossa hipótese foi de que a cetamina intravenosa baixa da dose durante a cirurgia ajudaria na mobilização após a artroplastia total do joelho (ATJ) em pacientes com oncologia, conforme avaliado pelo teste Timed Up and Go (TUG) às 72 horas após a cirurgia. Nossos objetivos secundários eram comparar o requisito de opioides no final de 72 horas, pontuações da dor, satisfação com o manejo da dor, efeitos adversos, faixa de movimento articular alcançado no período pós-operatório e a recuperação funcional no final de 1 mês.
Métodos
Após a aprovação da ética, o registro do estudo junto ao CTRI e o consentimento informado, este estudo duplo-cego foi realizado. Usando gráficos de randomização gerados por computador, uma equipe independente randomizou os pacientes no grupo de cetamina que receberam em indução, uma dose de bolo de cetamina de 0,5 mg.kg-1 antes da incisão seguida por infusão de 10 µg.kg-1.min-1 que foi mantida no intraoperatório até o fechamento da pele e o grupo salino recebeu um volume de solução salina equivalente. No pós -operatório, foram administradas bombas de morfina controladas pelo paciente e o escore de dor com uso de morfina foi registrado por 72 horas. Os testes de TUG e a amplitude de movimento foram avaliados pelos fisioterapeutas até 72 horas.
Resultados
Cinquenta e dois pacientes foram incluídos no estudo. Os dados demográficos eram comparáveis. Não foram observadas alterações hemodinâmicas intraoperatórias significativas e adverso pós-operatório entre os grupos. Uma diminuição no teste de rebocador, juntamente com a diminuição do uso de opioides com uma melhor gama de movimentos, foi observada no grupo cetamina, mas isso não foi estatisticamente significativo. O dia da alta, a pontuação da satisfação do paciente e a recuperação funcional avaliada pela Oxford Knee Score (OKS) foram comparáveis entre os grupos.
Conclusão
Em conclusão, a infusão de cetamina intraoperatória de baixa dose não fornece benefícios clínicos no manejo perioperatório da dor e na reabilitação pós -operatória após a substituição endoprotética total do joelho em oncologia.
Palavras-chave
References
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