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临床试验/NCT02829697
NCT02829697已完成4 期

The Effect of Local Anaesthetic Volume on Nerve Block Duration and Nerve Block Duration Variability. A Randomised, Blinded, Healthy Volunteer Study

Nordsjaellands Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Duration of sensory nerve block

研究概览

简要总结

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.

详细描述

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.

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)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Peroneal nerve: Ropivacaine 0.2%, 2.5 mL

Active Comparator

Perineural injection of ropivacaine 0.2 %, 2,5 mL

干预措施: Ropivacaine (Drug)

Peroneal nerve: Ropivacaine 0.2%, 5 mL

Active Comparator

Perineural injection of ropivacaine 0.2 %, 5 mL

干预措施: Ropivacaine (Drug)

Peroneal nerve: Ropivacaine 0.2%, 10 mL

Active Comparator

Perineural injection of ropivacaine 0.2 %, 10 mL

干预措施: Ropivacaine (Drug)

Peroneal nerve: Ropivacaine 0.2%, 15 mL

Active Comparator

Perineural injection of ropivacaine 0.2 %, 15 mL

干预措施: Ropivacaine (Drug)

Peroneal nerve: Ropivacaine 0.2%, 20 mL

Active Comparator

Perineural injection of ropivacaine 0.2 %, 20 mL

干预措施: Ropivacaine (Drug)

Sciatic nerve: Ropivacaine 0.2%, 5 mL

Active Comparator

Perineural injection of ropivacaine 0.2 %, 5 mL

干预措施: Ropivacaine (Drug)

Sciatic nerve: Ropivacaine 0.2%, 10 mL

Active Comparator

Perineural injection of ropivacaine 0.2 %, 10 mL

干预措施: Ropivacaine (Drug)

Sciatic nerve: Ropivacaine 0.2%, 15 mL

Active Comparator

Perineural injection of ropivacaine 0.2 %, 15 mL

干预措施: Ropivacaine (Drug)

Sciatic nerve: Ropivacaine 0.2%, 20 mL

Active Comparator

Perineural injection of ropivacaine 0.2 %, 20 mL

干预措施: Ropivacaine (Drug)

Sciatic nerve: Ropivacaine 0.2%, 30 mL

Active Comparator

Perineural injection of ropivacaine 0.2 %, 30 mL

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Duration of sensory nerve block

时间窗: 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.

次要结局

  • Length of nerve exposed to local anaesthesia(10 minutes)
  • Onset of sensory nerve block(10-180 minutes)
  • Onset of motor nerve block(10-180 minutes)
  • Degree of sensory nerve block(1-24 hours)
  • Degree of motor nerve block(1-24 hours)

研究者

发起方
Nordsjaellands Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Claus Behrend Christiansen

MD

Nordsjaellands Hospital

研究点 (1)

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