The Effect of the Popliteal Plexus Block on the Motor Function of the Leg - a Randomized, Controlled, Blinded Study in Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- MVIC (Maximum Voluntary Isometric Contraction) ankle plantarflexion
研究概览
简要总结
The aim of this study is to evaluate the Popliteal Plexus Block (PPB) effect on motor nerve branches of the sciatic and femoral nerve, when using different volumes of local anesthetics for PPB.
The hypothesis is that increasing the volume of anesthetics used for PPB will spread to the sciatic nerve leading to a reduced muscle strength in the lower leg and decreased nerve conduction velocity in the nerve to gastrocnemius muscle (the tibial nerve) and the nerve to anterior tibial muscle (the deep fibular nerve).
The effects will be evaluated by maximum voluntary isometric contraction (MVIC) of the lower leg muscles and by recordings of the compound muscle action potential (cMAP) of the gastrocnemius and tibialis anterior muscles - a motor nerve conduction study.
In addition, evaluation of PPBs effect on the femoral nerve is done by MVIC of the quadriceps femoris muscle, cMAP of the vastus medialis and vastus lateralis muscles and by a sensory nerve conduction study of the saphenous nerve.
详细描述
A total number of 40 volunteers will be enrolled in the study. Each volunteer will receive two peripheral nerve blocks (one in each leg) on the day of participation. This will result in 80 peripheral nerve blocks. The types of nerve blocks given to each leg on each volunteer will depend on randomization.
The 80 nerve blocks are divided into five groups specified by type of nerve block, volume of anesthetic used, and respective numbers of legs used in the group. The groups and specifications are listed here:
Groups name, type of peripheral nerve block, study medication dosage and number of legs in the group:
- Group A: PPB with 10 ml of lidocaine 1%, 20 legs.
- Group B: PPB with 20 ml of lidocaine 1%, 20 legs.
- Group C: PPB with 30 ml of lidocaine 1%, 20 legs.
- Group FNB: FNB with 20 ml of lidocaine 1%, 10 legs.
- Group SNB: SNB with 20 ml of lidocaine 1%, 10 legs.
Group FNB of SNB are performed unblinded and works as active comparatives for model control, in order to establish reference points for when a nerve is considered affected.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The study is an assessor- and volunteer-blinded randomized study. As different volumes are used for the nerve blocks, the anesthesiologist and an assistant performing the nerve blocks will not be blinded, and therefore have no further contact with the volunteers after the nerve block performance and will not contribute with the data collection or statistical analysis. The nerve block procedure and assessments will take place in different rooms; hence the data collecting assessors will not be present during block performance.To ensure blinding of the volunteer, a draping will hinder the volunteer from observing which volume of lidocaine that is administered during block performance.Group A, B and C are blinded until the data analysis is finished. Group FNB of SNB are unblinded and works as active comparatives for model control, in order to establish reference points for when a nerve is considered affected.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to give their written informed consent to participating in the study after having fully understood the contents of the study
排除标准
- •Subjects who cannot cooperate with the study.
- •Subjects who cannot understand or speak Danish.
- •Subjects with allergy to the medicines used in the study.
- •Subjects suffering from alcohol and/or drug abuse - based on the investigator's opinion.
- •Pathology or previous major surgery to the lower limb.
- •Intake of any analgesics 24 hours prior to baseline measurements.
- •BMI > 35
- •Active signs of infection in the cutaneous area of injection
- •Subjects diagnosed with epilepsy, neurologic diseases, severe hypoxia or respiratory depression, hypovolemia, shock, bradycardia or Wolff-Parkinson-Whites syndrome
- •Subjects with a positive pregnancy test**
- •Subjects diagnosed with cardiovascular disease or heart failure
- •Subjects diagnosed with partial or complete cardiac block
- •Subjects in daily treatment with class III antiarrhythmics (e.g. amiodarone)
- •Subjects in daily treatment with drugs that are structurally related to local analgesics or class IB antiarrhythmics
- •Subjects diagnosed with severe liver disease or reduced kidney function
研究组 & 干预措施
Groups SNB
Sciatic Nerve Block given with 20 ml og Lidocaine Hydrochloride 10 mg/ml
干预措施: Sciatic Nerve Block (Drug)
Group A
Popliteal Plexus Block given with 10 ml of Lidocaine Hydrochloride 10 mg/ml
干预措施: Popliteal Plexus Block with 10 ml (Drug)
Groups B
Popliteal Plexus Block given with 20 ml of Lidocaine Hydrochloride 10 mg/ml
干预措施: Popliteal Plexus Block with 20 ml (Drug)
Group C
Popliteal Plexus Block given with 30 ml of Lidocaine Hydrochloride 10 mg/ml
干预措施: Popliteal Plexus Block with 30 ml (Drug)
Group FNB
Femoral Nerve Block given with 20 ml of Lidocaine Hydrochloride 10 mg/ml
干预措施: Femoral Nerve Block (Drug)
结局指标
主要结局
MVIC (Maximum Voluntary Isometric Contraction) ankle plantarflexion
时间窗: Measured pre block and at 45 minutes post block
Difference between group A, B and C in post block MVIC by ankle plantarflexion, expressed as percentage change of the pre block value. MVIC is measured using a handheld dynamometer.
MVIC ankle dorsiflexion
时间窗: Measured pre block and at 45 minutes post block
Difference between group A, B and C in post block MVIC by ankle dorsiflexion, expressed as a percentage change of the pre block value. MVIC is measured using a handheld dynamometer.
次要结局
- MVIC knee extension(Measured pre block and at 45 minutes post block)
- cMAP (compoud motor action potention) gatrocnemius(Measured pre block and at 45 minutes post block)
- cMAP tibialis anterior(Measured pre block and at 45 minutes post block)
- cMAP vastus medialis(Measured pre block and at 45 minutes post block)
- cMAP vastus lateralis(Measured pre block and at 45 minutes post block)
- Saphenus senory test(Measured pre block and at 45 minutes post block)
研究者
Charlotte Runge
Medical Doctor, Specialist in Anesthesiology, PhD, Clinical Associate Professor
Regionshospitalet Silkeborg