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临床试验/NCT03777072
NCT03777072Unknown不适用

Evaluation of a Novel Web-based Application for Monitoring Postoperative Pain in Patients Underwent Total Ankle Replacement

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年12月12日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
1
主要终点
VAS score

研究概览

简要总结

The study evaluates a novel web-based application for monitoring the postoperative pain in patients undergoing total ankle replacement, from preoperative condition to 30 days follow-up. The indexes provided by the app in terms of percentages of pain areas are compared with that obtained with traditional visual analogue scale. Moreover, the relation between the percentage of pain area and the presence of side effects of the intervention are compared as well.

详细描述

Background:

The management of postoperative pain in patients undergoing total ankle replacement is routinely based on one of the two following drugs: tapentadol and oxycodone/naloxone (Nett, 2010). The drugs are used with similar frequencies. Indeed, previous studies compared the two drugs in terms of efficacy in reducing postoperative pain and frequency of side effects, in the field of orthopaedic and trauma surgery (Haeseler, 2017, Hartrick, 2009). The studies demonstrated that there are no substantial differences.

With regard to pain monitoring, the gold standard is the visual-analogue scale (VAS), which allows the patient to indicate the pain level as a score ranging from 0 to 10 (from minimum to maximum) (Campbell, 1990). Recently, a pain monitoring web-based application has been developed and distributed: 'NavigatePain' (NavigatePain, Aglance Solutions, Denmark). The app can be used in a simple and intuitive manner by PC, smartphone or tablet devices (Boudreau, 2016; Matthews, 2018). Moreover, physicians can easily schedule postoperative self-monitoring sessions for the patients (exploiting automatic notification messages sent by e-mail). The app allows the user to draw the pain areas in the frontal, posterior and lateral body planes, providing an index that quantifies the percentage of pain area with respect to the total body area in the considered plane. VAS score and notes reporting side effects can be reported as well in the app. Compared to VAS score, the pain area index is differentiated in the body planes and can represent a complementary and more specific source of information in monitoring postoperative pain.

Aim of the study:

The study evaluates the NavigatePain app for monitoring the postoperative pain in patients undergoing total ankle replacement, from preoperative condition to 30 days follow-up. The indexes provided by the app in terms of percentages of pain areas are compared to VAS reference score. Moreover, the relation between the percentage of pain area and the presence of side effects of the intervention are compared as well.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age from 18 to 60 years
  • ankle arthrosis grade 3 or 4, according to Kellgren-Lawrence classification
  • subject undergoing first implant of total ankle replacement
  • skeletal maturity
  • signed informed consent

排除标准

  • previous ankle replacement implants or ipsilateral ankle arthrodesis

结局指标

主要结局

VAS score

时间窗: Through study completion, an average of 18 months

Continuous value ranging from 0 (minimum) to 10 (maximum), indicating the pain level reported by patient.

Presence of side effects

时间窗: Through study completion, an average of 18 months

Dichotomic variable. Equal to 1 in case of reported side effects, 0 otherwise.

Pain area index

时间窗: Through study completion, an average of 18 months

Quantifies the percentage of pain area with respect to the total body area in the considered plane

次要结局

未报告次要终点

研究者

发起方
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
申办方类型
Other
责任方
Sponsor

研究点 (1)

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