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Inkk试验:肿瘤患者全膝关节置换术后围手术期疼痛管理中术中使用氯胺酮的双盲随机试验。

Inkk Trial .Çô Intraoperative ketamine for perioperative pain management following total knee endoprosthetic replacement in oncology: a double-blinded randomized trial.

作者信息

Paulin V Susan, Bakshi Sumitra G, Hegde Prateek C, Rathod Akanksha, Gulia Ashish, Kulkarni Ajeeta M, Paramanandam Vincent S

机构信息

Tata Memorial Hospital and Homi Bhabha National Institute, Department of Anaesthesia, Critical Care and Pain, Mumbai, India.

Tata Memorial Hospital and Homi Bhabha National Institute, Department of Anaesthesia, Critical Care and Pain, Mumbai, India.

出版信息

Braz J Anesthesiol. 2023 Jan-Feb;73(1):78-84. doi: 10.1016/j.bjane.2021.07.014. Epub 2021 Jul 28.

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.áhours post-surgery. Our secondary objectives were to compare the opioid requirement at the end of 72.áhours, 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 the ethics commitee approval, registration of the trial with the Clinical Trial Registry - India (CTRI), and informed consent, this double-blinded trial was conducted. Using computer generated randomization chart, an independent team randomized the patients into ketamine group which received at induction, a ketamine bolus dose of 0.5.ámg.kg before the incision followed by 10.á..g.kgmin infusion which was maintained intraoperatively till skin closure and the saline group received an equivalent volume of saline. Postoperatively, patient controlled morphine pumps were attached and the pain score with morphine usage were recorded for 72.áhours. The TUG tests and range of motion were assessed by the physiotherapists until 72.áhours.

RESULTS

Fifty-two patients were enrolled in the trial. Demographics were comparable. No significant intraoperative hemodynamic changes and post-operative adverse events 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.

摘要

背景

骨科手术后氯胺酮的应用越来越受到关注。我们假设,在手术过程中使用低剂量静脉注射氯胺酮,将有助于肿瘤患者全膝关节置换术(TKR)后的活动能力恢复,这通过术后72小时的起身行走时间(TUG)测试来评估。我们的次要目标是比较术后72小时结束时的阿片类药物需求量、疼痛评分、对疼痛管理的满意度、不良反应、术后关节活动范围以及术后1个月结束时的功能恢复情况。

方法

在获得伦理委员会批准、在印度临床试验注册中心(CTRI)注册该试验并取得知情同意后,进行了这项双盲试验。使用计算机生成的随机分组表,一个独立的团队将患者随机分为氯胺酮组和生理盐水组。氯胺酮组在诱导时,于切口前给予0.5mg/kg的氯胺酮推注剂量,随后以10μg/kg·min的速度持续输注,术中维持至皮肤缝合;生理盐水组接受等量的生理盐水。术后,连接患者自控吗啡泵,并记录72小时内的疼痛评分和吗啡使用情况。物理治疗师评估TUG测试和活动范围,直至术后72小时。

结果

52名患者纳入该试验。人口统计学特征具有可比性。两组之间未观察到显著的术中血流动力学变化和术后不良事件。氯胺酮组的TUG测试结果有所下降,同时阿片类药物使用量减少,关节活动范围改善,但差异无统计学意义。两组之间的出院日期、患者满意度评分以及通过牛津膝关节评分(OKS)评估的功能恢复情况相当。

结论

总之,低剂量术中输注氯胺酮在肿瘤患者全膝关节假体置换术后的围手术期疼痛管理和术后康复中未显示出临床益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cdb7/9801218/f329a1806736/gr1.jpg

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