The Effect of Local Anaesthetic Volume on Nerve Block Duration and Nerve Block Duration Variability
The Effect of Local Anaesthetic Volume on Nerve Block Duration and Nerve Block Duration Variability. A Randomised, Blinded, Healthy Volunteer Study
The aim is to investigate the effect of perineural administration of a series of different volumes of local anaesthesia (ropivacaine 0.2%) on nerve block duration and the variability of the duration in the common peroneal nerve and the sciatic nerve in healthy volunteers.
The hypothesis is that nerve block duration is correlated to local anaesthetic volume, but only to a certain degree. After a sufficient volume a 'saturation level' will be reached, and nerve block duration will not increase further.
研究概览
详细说明
The trial is divided into two similar phases. Each phase will focus on a specific nerve. Phase 1 will focus on the common peroneal nerve and Phase 2 will focus on the sciatic nerve.
After baseline measurements, the investigators will insert a peripheral intravenous catheter. Then, the investigators will insert a suture-method peripheral nerve catheter (Certa CatheterTM). Procedures will be done in a sterile manner as a standard of practice. The investigators will use an ultrasound (US)-guided short-axis, needle in-plane technique. For the US-scan, the investigators will use a linear or a curvilinear transducer.
During interventions, volunteers will be monitored with continuous pulse oximetry. Placement of the peripheral nerve catheter will be facilitated by US using small injections of mepivacaine (carbocaine 2 %) in the skin and surrounding tissues and only isotonic saline (5 mL) in the perineural space to prevent blocking of the nerve before ropivacaine injection. The catheter orifice will be placed by pulling either end of the catheter and guided by the built-in echogenic markings seen on US. Before injection of ropivacaine, the investigators will do careful aspirations through the catheter in order to prevent intravasal injection.
Each ropivacaine injection will be administered via an infusion pump. This will ensure a constant infusion rate set to 10 mL per minute. During infusion, the volunteers will be monitored with continuous pulse oximetry.
Before instigation of the ropivacaine infusion, the investigators will use US to verify full absorption of the isotonic saline in the perineural space.
For each nerve, the subject will be randomly allocated to and receive one of five possible ropivacaine volumes. All volunteers and outcome assessors will be blinded to the ropivacaine administrations and infusion procedures. Outcome assessors will not be in the room, when the medication is prepared nor given. Preparation will take place behind a curtain and therefore also blinded to the volunteers.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
-
Hillerød、丹麦、DK-3400
- Claus Behrend Christiansen
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria
- Male or female 18-64 years
- American Society of Anesthesiologists Classification ≤ II
Exclusion criteria
- Body Mass Index ≤ 18 or ≥ 30
- Former surgery to the lower extremities
- Peripheral nerve disease
- Allergy to ropivacaine
- Pregnancy or breastfeeding
- Enrolment in other investigational drug studies or recent clinical trials that may interfere with this study
- Habitual use of any kind of analgesic treatment
- Anatomic abnormalities preventing successful US-guided peripheral nerve catheter insertion
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Peroneal nerve: Ropivacaine 0.2%, 2.5 mL
Perineural injection of ropivacaine 0.2 %, 2,5 mL
|
Perineural injection.
|
|
有源比较器：Peroneal nerve: Ropivacaine 0.2%, 5 mL
Perineural injection of ropivacaine 0.2 %, 5 mL
|
Perineural injection.
|
|
有源比较器：Peroneal nerve: Ropivacaine 0.2%, 10 mL
Perineural injection of ropivacaine 0.2 %, 10 mL
|
Perineural injection.
|
|
有源比较器：Peroneal nerve: Ropivacaine 0.2%, 15 mL
Perineural injection of ropivacaine 0.2 %, 15 mL
|
Perineural injection.
|
|
有源比较器：Peroneal nerve: Ropivacaine 0.2%, 20 mL
Perineural injection of ropivacaine 0.2 %, 20 mL
|
Perineural injection.
|
|
有源比较器：Sciatic nerve: Ropivacaine 0.2%, 5 mL
Perineural injection of ropivacaine 0.2 %, 5 mL
|
Perineural injection.
|
|
有源比较器：Sciatic nerve: Ropivacaine 0.2%, 10 mL
Perineural injection of ropivacaine 0.2 %, 10 mL
|
Perineural injection.
|
|
有源比较器：Sciatic nerve: Ropivacaine 0.2%, 15 mL
Perineural injection of ropivacaine 0.2 %, 15 mL
|
Perineural injection.
|
|
有源比较器：Sciatic nerve: Ropivacaine 0.2%, 20 mL
Perineural injection of ropivacaine 0.2 %, 20 mL
|
Perineural injection.
|
|
有源比较器：Sciatic nerve: Ropivacaine 0.2%, 30 mL
Perineural injection of ropivacaine 0.2 %, 30 mL
|
Perineural injection.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Duration of sensory nerve block
大体时间：1-24 hours
|
Application of a round, cooled glass container in the sensory distribution area of the tested nerve: The lateral part of the lower leg for the common peroneal nerve and beneath the foot for the tibial nerve.
Testing will start after onset of sensory nerve block and continue until normal sensation has returned.
When testing the sciatic nerve, we will continue testing until normal sensation has returned in both components of the nerve, i.e. the tibial and common peroneal nerve.
|
1-24 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Length of nerve exposed to local anaesthesia
大体时间：10 minutes
|
We will measure local anaesthetic spread in a proximal-to-distal manner parallel to the nerve trajectory.
Total length of the neural spread will be reported in millimetres from the most proximal point to the most distal point in which fluid, i.e. ropivacaine, is seen on ultrasound in proximity to the nerve.
Testing will be done immediately after end of ropivacaine infusion.
|
10 minutes
|
|
Onset of sensory nerve block
大体时间：10-180 minutes
|
Application of a round, cooled glass container in the sensory distribution area of the tested nerve: The lateral part of the lower leg for the common peroneal nerve and beneath the foot for the tibial nerve.
Testing will start ten minutes after end of infusion and continue for every fifth minute until onset.
We will test for a maximum of 180 minutes.
|
10-180 minutes
|
|
Onset of motor nerve block
大体时间：10-180 minutes
|
Testing will start ten minutes after end of infusion and continue for every fifth minute until onset.
When onset of sensory nerve block is confirmed, testing of motor nerve block onset will end as well, if not already found.
Motor nerve block of the tibial nerve will be evaluated by plantarflexion of the ankle.
Motor nerve block of the common peroneal nerve will be tested by dorsiflexion of the ankle.
|
10-180 minutes
|
|
Degree of sensory nerve block
大体时间：1-24 hours
|
We will test sensory nerve block using a subjective rating scale.
We will grade from one to four: 1) "not different from ipsilateral antebrachium"; 2) "different from ipsilateral antebrachium"; 3) "warm sensation"; 4) "no sensation".
Grades 2-4 will be considered as successful sensory nerve blocks.
It will be noted if the volunteer is in doubt.
Nevertheless, this will be considered as a successful sensory nerve block and graded as 2) in the post hoc statistical analyses.
|
1-24 hours
|
|
Degree of motor nerve block
大体时间：1-24 hours
|
This will be tested with the volunteer in the upright position using a sturdy counter for balance if necessary.
Motor strength will be evaluated using a normal everyday activation of the lower leg: A toe and a heel raise, testing the common peroneal nerve via activation of the anterior tibial muscle and the tibial nerve via activation of the gastrocnemius muscle, respectively.
Motor nerve block intensity will be evaluated on a scale from one to three: 1) normal strength, 2) paresis or 3) paralysis.
Volunteers will be asked to perform a maximum contraction building up muscle force over three seconds.
It will be noted if the volunteer is in doubt, which will be considered as 2) paresis in the post hoc statistical analyses.
|
1-24 hours
|
合作者和调查者
调查人员
- 研究主任：Kai Henrik Wiborg Lange, MD DMSC、Nordsjællands Hospital Hillerød
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.