The Effect of Different Doses (Mass) of Local Anesthetic on Duration of Adductor Canal Block in Healthy Volunteers - Part 2
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Duration of sensory block assessed with pinprick.
研究概览
简要总结
To investigate whether increased dose of local anesthetic (lidocaine) increases duration of peripheral nerve block (adductor canal block) and to develop a model for assessing duration of peripheral nerve blockades. The investigators hypothesize that increasing the dose of lidocaine (by increased concentration) will increase the duration of an adductor canal block.
The study is a follow up on an identical study (SM1-PJ-13, EudraCT number: 2013-001822-24 ) made earlier with different concentrations of lidocaine and a placebo group. For further information see trial registration at European Union Drug Regulatory Authorities Clinical Trial System.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index 18-25
排除标准
- •Allergy to study medication
- •Earlier trauma or surgery to lower limb
- •Diabetes Mellitus
研究组 & 干预措施
ACB with lidocaine 5 mg/ml
Adductor canal block (ACB) with 20 ml lidocaine 5 mg/ml, single bolus
干预措施: Adductor canal block with 20 ml lidocaine, single bolus (Drug)
ACB with lidocaine 15 mg/ml
Adductor canal block with 20 ml lidocaine 15 mg/ml, single bolus
干预措施: Adductor canal block with 20 ml lidocaine, single bolus (Drug)
结局指标
主要结局
Duration of sensory block assessed with pinprick.
时间窗: 0-10 hours
Duration is defined as the time from block performance until recovery of sensation to pin-prick stimulus, assessed at 30 and 60 minutes post block, and thereafter every hour.
次要结局
- Duration of sensory block assessed by heat pain detection threshold(0-10 hours)
- Duration of sensory block assessed by warmth detection threshold(0-10 hours)
- Duration of sensory block assessed by pain during 1 minute of warmth stimulation(0-10 hours)
- Duration of sensory block assessed by tolerance to transcutaneal electrical stimulation(0-10 hours)
- Duration of sensory block assessed by cold sensation with an alcohol swab(0-10 hours)
- Duration of motor block assessed as maximum voluntary isometric contraction.(0-10 hours)
- Time to onset of sensory block assessed by pinprick.(0-2 hours)
研究者
Pia Jaeger
Principal investigator
Rigshospitalet, Denmark