ISRCTN08382589已完成不适用

Evaluation of a new device (patent publication GB 2366729) for identification of the epidural space

Record Provided by the NHSTCT Register - 2006 Update - Department of Health0 个研究点目标入组 400 人开始时间: 2006年9月29日最近更新: 2015年1月13日

适应症

试验速览

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•We have estimated that 400 patients (200 Epidrums) will be required for this study. This was estimated for the required significance of difference at a p value of less than 0.05 and for the average failure rate quoted above, number of attempts at epidural needle insertion and ease of its use scale, and the expected differences in learning curves. We estimated that the power of this study with the number of patients above will not be enough for incidence of complication such PDPH, and neurological complications which will be tested later in larger multi-centre trials. Two hundred patients in each group, sixteen to eighty years.
•1. Patients over 18 and under 80 years of age
•2 Clinical need for epidural injection
•3. Absence of any contraindication to epidural injection, relative or absolute

•1. Patients under 18 and over 80 years of age
•2. Bleeding tendency, local infection, bacteraemia or septicaemia
•3. Unable or unwilling to give consent
•4. All other relative clinical contraindications to epidural injection or anaesthesia

发起方

Record Provided by the NHSTCT Register - 2006 Update - Department of Health