Randomized Controlled Doubleblind Pilot Study Comparing Analgosedation Concepts During Placement of Regional Anaesthesia With Either Fentanyl, Remifentanil, Clonidine, EMLA-Patch or Placebo in Regard of Pain Reduction.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain intensity during placement of the regional anaesthesia
研究概览
简要总结
Aim of the study is to specify the best analgosedation technique during placement of regional anaesthesia from the patients' view.
In this double blind randomized trial the investigators will be testing the application of drugs administered intravenously (fentanyl-bolus, remifentanil-infusion, clonidine-bolus) or transcutaneously (EMLA salve) or placebo (NaCl 0,9% i.v. and skin protection salve).
详细描述
In this doubleblind randomized pilot trial, patients will receive one of five possible combinations to assess which medication leads to the best medication during placement of regional anaesthesia. This assessement includes NRS, patients' satisfaction and wellbeing. The tested substances will be administered intravenously (fentanyl-bolus, remifentanil-infusion, clonidine-bolus) or transcutaneously (EMLA salve). The fifth combination will be the control group with only placebo medication. We expected to get first information for objectifying analgosedation during placement of regional anaesthesia for the conduction of further studies in this field.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult patients planed electively for orthopedic surgery
排除标准
- •Missing patient's consent
- •Intolerance against study medication
研究组 & 干预措施
Placebo
Patients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve)
干预措施: Placebo iv (Drug)
Remifentanil i.v.
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
干预措施: Placebo salve (Drug)
EMLA salve
Patients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo
干预措施: Placebo iv (Drug)
Fentanyl i.v. (intravenously)
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
干预措施: Placebo salve (Drug)
Clonidine i.v.
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
干预措施: Placebo salve (Drug)
Placebo
Patients will be administered i.v. placebo (0,9% NaCl) and placebo salve (skin protection salve)
干预措施: Placebo salve (Drug)
EMLA salve
Patients will be administered the medication (salve) and additionally will be administered i.v. saline as placebo
干预措施: EMLA Cream (Drug)
Fentanyl i.v. (intravenously)
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
干预措施: Fentanyl (Drug)
Clonidine i.v.
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
干预措施: Clonidine (Drug)
Remifentanil i.v.
Patients will be administered the medication and additionally will be treated with placebo salve (skin protection salve)
干预措施: Remifentanil (Drug)
结局指标
主要结局
Pain intensity during placement of the regional anaesthesia
时间窗: 1 day
Pain assessment during placement of the regional anaesthesia with the Numeric Rating Scale (NRS 1 to 10, with 1=lowest pain score, 10=highest pain score). Lower NRS describes a better outcome.
次要结局
- Complication rate (delirium, allergic reactions, cardiopulmonary decompensation)(Through study completion, an average of 1 day)
- Patients' wellbeing(1 day)