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临床试验/CTRI/2016/01/006569
CTRI/2016/01/006569已完成不适用

Total intravenous anaesthesia versus subarachnoid block in unilateral total knee arthroplasty: A comparison of recovery profile and time to readiness for discharge

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年1月20日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
1.Time to readiness for discharge as measured by the proportion of patients in each group meeting the discharge readiness criteria on subsequent postoperative days, with assessment starting from day 2 onwards

研究概览

简要总结

The ideal anaesthetic technique for total knee arthroplasty(TKA) remains controversial with previous studies showing varied results. Though the superiority of neuraxial anaesthesia over general anaesthesia in terms of postoperative recovery, morbidity and mortality has been demonstrated in several earlier studies, recent studies evaluating modern general anaesthetic techniques like target controlled infusion have shown faster and better recovery with GA, especially when used in conjunction with multi-modal analgesia and accelerated rehabilitative regimens. While neuraxial blockade is largely considered safe, it is not without risks – it is invasive and although rare, does have the potential for spinal haematoma, infection, abscess, and nerve damage. Neuraxial blockade has also been reported to be associated with adverse cardiovascular outcomes in patients who are already at high risk for increased cardiovascular morbidity. Patients’ preference for general anaesthesia when compared to regional techniques has been shown in a few studies. A systematic review by Macfarlane et al evaluating contemporary studies comparing regional and general anaesthesia failed to demonstrate clear cut benefits of neuraxial anaesthesia over general anaesthesia for the intraoperative management of TKA.

Thus, there is a lack of consensus regarding the best method of anaesthesia for patients undergoing TKA and further studies are required to investigate the different anaesthetic techniques, including total intravenous anaesthesia, for patients undergoing TKA. This study was initiated to compare the time to readiness for discharge and the postoperative recovery profile after total intravenous general anaesthesia or subarachnoid block for unilateral total knee arthroplasty.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients willing to undergo elective, primary, unilateral total knee arthroplasty under general or spinal anaesthesia, with age 18 – 85 years and belonging to American Society of Anesthesiologists Physical Status (ASA PS) I – III.

排除标准

  • 1.Patient’s refusal to take part in the study 2.Bilateral / Revision total knee arthroplasty 3.Morbid obesity (BMI ≥ 40 ) 4.History of allergy to the drugs used in the study 5.History of regular opioid use 6.Contraindications to spinal anesthesia 7.Inability to understand information regarding Visual Analogue Scale 8.Inability to understand the use of patient controlled analgesia device.

结局指标

主要结局

1.Time to readiness for discharge as measured by the proportion of patients in each group meeting the discharge readiness criteria on subsequent postoperative days, with assessment starting from day 2 onwards

时间窗: Everyday from postoperative day 2 onwards till discharge criteria is met

次要结局

  • postoperative opioid consumption and postoperative recovery profile - postoperative pain, urinary retention, nausea and vomiting(first 24 hours postoperatively)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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