An Estimate of the ED95 of Lidocaine 1.0% for Filling the Adductor Canal When Placing an Adductor Canal Block in Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To estimate the ED 95 for the volume needed to fill the adductor canal distally.
研究概览
简要总结
The aim of this prospective dose finding study is to estimate the minimal effective volume (ED95) for lidocaine 1.0% for filling the adductor canal when placing an adductor canal block. We will apply the Continual Reassessment Method (CRM) for estimating the ED95 and use an MRI scan to evaluate the main objective and ensure spread to the distal part of the adductor canal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-30 years
- •American Society of Anesthesiologists' class 1
- •Body Mass Index 18-25
排除标准
- •Allergy to study medication
- •Earlier trauma or surgery to the lower limb
- •Diabetes Mellitus - Contraindications to MRI
研究组 & 干预措施
ACB with 30 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
干预措施: Adductor canal block with lidocaine 1% (Procedure)
ACB with 30 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
干预措施: Lidocaine (Drug)
ACB with 5 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
干预措施: Adductor canal block with lidocaine 1% (Procedure)
ACB with 25 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
干预措施: Adductor canal block with lidocaine 1% (Procedure)
ACB with 25 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
干预措施: Lidocaine (Drug)
ACB with 20 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
干预措施: Adductor canal block with lidocaine 1% (Procedure)
ACB with 20 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
干预措施: Lidocaine (Drug)
ACB with 15 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
干预措施: Adductor canal block with lidocaine 1% (Procedure)
ACB with 15 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
干预措施: Lidocaine (Drug)
ACB with 10 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
干预措施: Adductor canal block with lidocaine 1% (Procedure)
ACB with 10 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
干预措施: Lidocaine (Drug)
ACB with 5 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
干预措施: Lidocaine (Drug)
结局指标
主要结局
To estimate the ED 95 for the volume needed to fill the adductor canal distally.
时间窗: MRI performed 15 minutes post block
This will be evaluated as a binary outcome using MRI; where the adductor canal is considered to be filled if the lidocaine injectate can be identified inside the canal in the first slice distally to the insertion of the adductor longus muscle on femur.
次要结局
- To investigate the effect of volume on proximal spread to the femoral triangle(MRI performed 15 minutes post block)
- Quadriceps muscle strength(1 hour post block)
- Pin prick test(1 hour post block)
- Temperature discrimination test(1 hour post block)
研究者
Pia Jaeger
MD
Rigshospitalet, Denmark