Efficacy of the Application of Xylocaine Impregnated Compress in Reducing Per-procedural Pain During Ultrasound-guided Infiltration of Trigger Finger: a Randomized, Double-blind Controlled Study (SAUTYLO)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Average pain intensity during the ultrasound-guided infiltration.
研究概览
简要总结
The purpose of this study is to assess the efficacy of Xylocaine impregnated compress in reducing per-procedural pain during ultrasound-guided infiltration of Trigger Finger
详细描述
Trigger finger ultrasound-guided infiltrations are frequent and painful invasive procedures.
However, there is no current recommendation for per-procedural pain management, and in the majority of cases, infiltration is performed without prior skin anesthesia.
Xylocaine patches are of controversial efficacy in pain acute management. In current practice, they are not prescribed in advance and they are not well adapted to the topography of the finger.
On the other hand, a recent study showed the interest of administering lidocaine 2% by J-tip, a needle-free injection technique not available in France, before infiltration of Trigger Finger.
The investigators hypothesize that an impregnated compress in Xylocaine 20 mg/ml injectable solution, applied 15 minutes before the procedure, would reduce per-procedural pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Patients aged 18 years or older
- •Trigger Finger (clinically defined by painful difficulty or protrusion when extending the finger) with an ultrasound-guided infiltration of cortisone derivatives indication.
- •Written consent
- •Affiliation to a Social Security system
- •Prior medical examination
排除标准
- •Neurological conditions affecting the hand other than carpal tunnel syndrome
- •Intra-articular infiltration of the hand or the wrist ≤ 2 months
- •Allergy to Xylocaine
- •Contraindication to Xylocaine or cortisone derivatives
- •Cognitive or behavioral disorders that make assessment impossible
- •Persons referred to in articles L 1121-5; 6; 8; 9 of the Public Health Code (protected adults, under guardianship or curatorship, etc)
- •Pregnancy and breastfeeding; absence of contraceptive method for women of childbearing age
- •Participant unable to speak, read and write French
研究组 & 干预措施
xylocaine
干预措施: Lidocaïne Aguettant 20 mg/ml (Drug)
Placebo
干预措施: NaCl 0,9% (Drug)
结局指标
主要结局
Average pain intensity during the ultrasound-guided infiltration.
时间窗: Day 0, immadiately after infiltration
Evaluation assessed by self-administered pain numeric rating scale (0, no pain and 100, maximum pain).
次要结局
- Pain acceptance level assessed by the operator during the ultrasound-guided infiltration of trigger finger(Day 0)
- Adverse Events(Day 0)
- Pain acceptance level in patients with trigger finger during the ultrasound-guided infiltration(Day 0)