Effect of Ultrasound-guided Lateral Infraclavicular Brachial Plexus Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures - A Randomized Controlled Non-inferiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Block success
研究概览
简要总结
To investigate the feasibility of the lateral infraclavicular plexus brachialis (LIC) block for acute closed reduction of distal radius fractures, the investigators will compare the pain-relieving and muscle-relaxing properties of the LIC block with short- and long-acting local anesthetics in different concentrations but at the same volume. In addition to motor and sensory blockade during repositioning, feasibility will also be assessed by other patient-related and block-related factors, as well as by factors related to the repositioning and plastering procedure.
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
- •Patients who have given written informed consent to participate in the study after having understood it, as well as:
- •Having a distal radius fracture requiring closed reduction
排除标准
- •Patients who meet one or more of the following criteria will be excluded from participating in the study:
- •BMI > 40 kg/m2
- •Weight < 50 kg
- •Age < 18 years
- •American Society of Anesthesiologists (ASA) physical status classification system grade >3
- •Allergy to experimental drugs
- •Patients who cannot cooperate with the examinations or treatment
- •Patients who do not understand or speak Danish
- •Patients with peripheral or central neurological disease or nerve damage with neurological effect on the upper extremity, where closed reduction is required
研究组 & 干预措施
Ropivacaine 5 mg/ml
30 ml of ropivacaine 5 mg/ml (Injectable solution - perineural administration - only once)
干预措施: Ropivacaine 0.5% Injectable Solution (Drug)
Ropivacaine 2 mg/ml
30 ml of ropivacaine 2 mg/ml (Injectable solution - perineural administration - only once)
干预措施: Ropivacaine 0.2% Injectable Solution (Drug)
Lidocaine 10 mg/ml
30 ml of lidocaine 10 mg/ml with epinephrine 5 μg/ml (Injectable solution - perineural administration - only once)
干预措施: Lidocaine epinephrine (Drug)
结局指标
主要结局
Block success
时间窗: 45 minutes after block performance
The incidence of successful blockade 45 minutes after block performance. The following 4 nerves will be tested: radial, musculocutaneous, ulnar and median nerves. Sensory blockade assessment: * A 3-point scale is used for cold sensation assessment: 1 point = normal sensation of cold, 2 points = reduced sensation of cold and 3 points = no cold sensation. * A complete sensory blockade is defined as all four nerves obtaining 3 points (no cold sensation). Motor blockade assessment: * Assessment is done using a 4-point Manual Muscle Testing Scale: 3 points = no difference, the movement against resistance is possible, 2 points = a slight difference, the movement against slight resistance is possible, 1 point = movement is significantly compromised, 0 points = paralysis. * A complete motor blockade is defined as all four nerves obtaining: 1 point or 0 points. Successful blockade: • Complete sensory and motor blockade 45 minutes after block performance.
次要结局
未报告次要终点