NCT03889288Unknown不适用
Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer: First in Human Evaluation in Perioperative With Regard to a Control Group
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2019年6月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Cumulative consumption of morphine auto-administered in the experimental group in the first 48 hours : descriptive analysis
研究概览
简要总结
The objective of this study is to evaluate a new medical device in the management of pain. The principle of this new treatment is based on the emission of electromagnetic radiation in millimeter band. This new modality of pain management is evaluated in a perioperative management in patients undergoing surgery for aortic valve replacement.
The hypothesis is that the use of this medical device in perioperative would reduce the consumption of postoperative morphine with an identical quality of analgesia. The decline in morphine consumption would allow a decrease in opioid adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •candidate for an aortic valve replacement with extra-corporal flow.
- •wrist size between 14.5 and 18.5 centimeters (for the experimental group)
- •patient affiliated to social security
- •signature of the informed consent (for the experimental group)
排除标准
- •for the control group :
- •patient with diabetes
- •patient with an evolutive cancer
- •patient with cardiac assistance
- •patient under the influence of opioid in the 48 hours before the surgery
- •patient deprived of liberty by judicial or administrative decision
- •patient subject to legal protection or unable to express his consent (guardianship or curators)
- •Exclusion Criteria for the experimental group :
- •patient with diabetes
- •patient with an evolutive cancer
- •patient with surgery planning within 48 hours
- •patient with cardiac assistance
- •patient under the influence of opioid in the 48 hours before the surgery
- •patient suffering from a dermatological disease such as oozing dermatitis, hyper sweating, or an unhealed lesion in the wrists.
- •patient who has a piercing in the wrist or another metal material
- •patient known for having a multi-resistant bacterial strain
- •protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
- •exclusion period of another interventional study
结局指标
主要结局
Cumulative consumption of morphine auto-administered in the experimental group in the first 48 hours : descriptive analysis
时间窗: 48 hours
The morphine cumulative consumption administered by auto-analgesia in the experimental group at 24 and 48 hours after the surgery
次要结局
- The hospitalization length in the intensive care unit(48 hours)
- Characterization of analgesic drugs(48 hours)
- Number of postoperative nausea or vomiting events (number of PONV) in the experimental group(48 hours)
- Delirium events in the experimental group(48 hours)
- Cumulative consumption of morphine auto-administered in the control group in the first 48 hours : descriptive analysis(48 hours)
- Troponin's peak characterization in the first 48 hours postoperatively.(48 hours)
- Medical device acceptability : score(48 hours)
- Medical device acceptability : descriptive analysis(48 hours)
- Adverse effect from the medical device(48 hours)
- Description of the medical device use(48 hours)
- Use Error evaluation : System Usability Scale (SUS)(48 hours)
- Determine the number of patients required to demonstrate a 30% decrease in morphine consumption within the first 48h following aortic valve replacement surgery in a population treated with "Electronic-Pain-Killer" compared to conventional pain management(48 hours)
- The Pain characterization: Echelle Numérique Standard; standard digital scale(48 hours)
- Subgroup analysis excluding patients who have had Nefopam administration(48 hours)
研究者
研究点 (2)
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