The Effect of Combining Lidocaine and Ropivacaine on the Duration and Onset Time of an Ultrasound-guided Infraclavicular Brachial Plexus Nerve Block. a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Total time to breakthrough pain
研究概览
简要总结
The aim of the study is to investigate how the combination of ropivacaine (a slow onset, long duration local anesthetic) with lidocaine (a rapid onset, shorter duration local anesthetic) affects the onset and duration of a lateral infraclavicular plexus brachialis (LIC) block in patients undergoing non-acute hand surgery.
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
- •Scheduled for non-acute hand surgery in regional anesthesia
- •Scheduled for surgery on one of the following: 1) Antebrachium fractures or 2) Arthroplasty of a thumb base joint or 3) alloplasty of a thumb base joint
排除标准
- •BMI > 40 kg/m2
- •Weight < 60 kg
- •Age < 18 years
- •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 surgery is required
研究组 & 干预措施
Control group: Ropi-5
30 ml Ropivacaine 5 mg/ml (equivalent to 150 mg Ropivacaine)
干预措施: Ropivacaine 0.5% Injectable Solution (Drug)
Intervention group 1: Ropi-5+Lido-20
20 mL Ropivacaine 5 mg/ml + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 100 mg Ropivacaine + 200 mg Lidocaine)
干预措施: Ropivacaine 0.5% Injectable Solution (Drug)
Intervention group 1: Ropi-5+Lido-20
20 mL Ropivacaine 5 mg/ml + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 100 mg Ropivacaine + 200 mg Lidocaine)
干预措施: Lidocaine epinephrine (Drug)
Intervention group 2: Ropi-7.5+Lido-20
20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 150 mg Ropivacaine + 200 mg Lidocaine)
干预措施: Lidocaine epinephrine (Drug)
Intervention group 2: Ropi-7.5+Lido-20
20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 150 mg Ropivacaine + 200 mg Lidocaine)
干预措施: Ropivacaine 0.75% Injectable Solution (Drug)
结局指标
主要结局
Total time to breakthrough pain
时间窗: 24 hours
From the completion of the LIC block to first sensation of pain from the surgical area.
次要结局
- Total duration of sensory blockade(24 hours)
- Total duration of motor blockade(24 hours)
- The onset of sensory block(Until max 45 minutes)
- Degree of motor blockade(At complete sensory blockade and otherwise 45 minutes after block performance)