VENLID: A Prospective, Randomized, Double-blind, Controlled Trial on the Application of a 10%-Lidocaine Spray Prior to the Insertion of a Peripheral Intra-venous Catheter in Female Adults
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- To demonstrate a reduction of pain caused by PIVC rated by Numerical Rating Scale (NRS), after application of a 10% lidocaine spray- Separately measured for the plantar side of the hand/vessel at the dorsum manus, and for the forearm/cubita
研究概览
简要总结
Volunteers are invited to undergo 4 insertions of a peripheral intra-venous 18-gauge catheter (PIVC); 2 insertions at the the start of the study on the plantar side of the hand/vessel at the dorsum manus, 2 insertions after 2-10 hours into the forearm/cubita with and without application of a 10-% lidocaine spray (5 hubs of xylocaine 10%-pump spray; AstraZeneca BV, Zoetermeer, The Netherlands) prior to the insertion of the PIVC.
详细描述
Visit schedule:
Visit 1 Screening: Informed consent, Inclusion and exclusion criteria, Medical history, urine pregnancy test
Visit 2 Treatment Day1: PIVC vessel dorsum manus+ PIVC forearm/cubita
Treatment Day 1:
First, volunteers will undergo insertion of PIVC into the vessel at the dorsum manus; Volunteers are randomized in 4 groups, volunteers serve as there own controls
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A: dominant/ Saline solution isotonic 0.9% NaCl - non-dominant/Xylocaine 10% pump spray
Vessel at the dorsum manus: dominant/ placebo - non-dominant/ LA (Local anaesthesia)
Forearm/cubita: dominant/ placebo - non dominant/ LA (Local anaesthesia)
干预措施: Xylocaine 10% pump spray (Drug)
A: dominant/ Saline solution isotonic 0.9% NaCl - non-dominant/Xylocaine 10% pump spray
Vessel at the dorsum manus: dominant/ placebo - non-dominant/ LA (Local anaesthesia)
Forearm/cubita: dominant/ placebo - non dominant/ LA (Local anaesthesia)
干预措施: Saline solution isotonic 0.9% NaCl (Drug)
B: non-dominant/ Saline solution isotonic 0.9% NaCl - dominant/ Xylocaine 10% pump spray
Vessel at the dorsum manus: non-dominant/ placebo - dominant/ LA (Local anaesthesia)
Forearm/cubita: non-dominant/ placebo - dominant/ LA (Local anaesthesia)
干预措施: Xylocaine 10% pump spray (Drug)
B: non-dominant/ Saline solution isotonic 0.9% NaCl - dominant/ Xylocaine 10% pump spray
Vessel at the dorsum manus: non-dominant/ placebo - dominant/ LA (Local anaesthesia)
Forearm/cubita: non-dominant/ placebo - dominant/ LA (Local anaesthesia)
干预措施: Saline solution isotonic 0.9% NaCl (Drug)
C: non-dominant/ Xylocaine 10% pump spray - dominant/ Saline solution isotonic 0.9% NaCl
Vessel at the dorsum manus: non-dominant/ LA (Local anaesthesia)- dominant/ placebo
Forearm/cubita: non-dominant/ LA (Local anaesthesia) - dominant/ placebo
干预措施: Xylocaine 10% pump spray (Drug)
C: non-dominant/ Xylocaine 10% pump spray - dominant/ Saline solution isotonic 0.9% NaCl
Vessel at the dorsum manus: non-dominant/ LA (Local anaesthesia)- dominant/ placebo
Forearm/cubita: non-dominant/ LA (Local anaesthesia) - dominant/ placebo
干预措施: Saline solution isotonic 0.9% NaCl (Drug)
D: dominant/ Xylocaine 10% pump spray - non-dominant/ Saline solution isotonic 0.9% NaCl
Vessel at the dorsum manus: dominant/ LA (Local anaesthesia) - non-dominant/ placebo
Forearm/cubita: dominant/ LA (Local anaesthesia) - non-dominant/ placebo
干预措施: Xylocaine 10% pump spray (Drug)
D: dominant/ Xylocaine 10% pump spray - non-dominant/ Saline solution isotonic 0.9% NaCl
Vessel at the dorsum manus: dominant/ LA (Local anaesthesia) - non-dominant/ placebo
Forearm/cubita: dominant/ LA (Local anaesthesia) - non-dominant/ placebo
干预措施: Saline solution isotonic 0.9% NaCl (Drug)
结局指标
主要结局
To demonstrate a reduction of pain caused by PIVC rated by Numerical Rating Scale (NRS), after application of a 10% lidocaine spray- Separately measured for the plantar side of the hand/vessel at the dorsum manus, and for the forearm/cubita
时间窗: 2 minutes
rated by a Numerical Rating Scale (NRS) from minimum 0 to maximum 10. Higher score means worse outcome
次要结局
- To measure the correlation between pain caused by PIVC rated by NRS and the anticipated pain rated by NRS(2 minutes)
- To measure pain caused by PIVC rated by NRS in the dominant vs. non-dominant arm(2 minutes)
- To measure pain caused by PIVC rated by NRS at the plantar side of the hand/vessel at the dorsum manus vs. at the forearm/cubita(2 minutes)
- To measure pain rated by NRS depending on success(2 minutes)
- To measure the correlation between pain caused by PIVC rated by NRS and the anticipated difficulty by the operator to insert the PIVC(2 minutes)
- To describe success rates and compare it(2 minutes)
- To measure the correlation between PCS and pain caused by PIVC rated by NRS(2 minutes)