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临床试验/NCT02050295
NCT02050295终止不适用

A Novel Approach to Reverse and Titrate the Clinical Effects of a Nerve Block

University of Alberta1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
31
试验地点
1
主要终点
Motor function

研究概览

简要总结

Injecting local anesthetic to anesthetize a nerve or group of nerves (a 'nerve block') is an effective way to eliminate pain during and after surgery. There are instances when it would be beneficial to the patient for the nerve block to be resolved quickly rather than waiting for it to naturally wear off. For example, a sciatic nerve block that freezes the lower leg and foot typically takes over 18 hours to resolve on its own, and both the surgeon and patient prefer to have motor function before discharge. The investigators wish to perform a randomized, controlled trial to determine if infusion of a solution such as saline to 'wash out' the nerve block after surgery can allow the patient to be pain-free while still being able to move their leg and foot.

详细描述

Background and rationale Peripheral nerve blocks provide effective surgical anesthesia targeted to specific body regions while avoiding the unpleasant side-effects of general anesthesia. Additionally, infusion of local anesthetic (LA) solution through a perineural catheter can provide superior analgesia compared to opioid painkillers and reduces the incidence of opioid-associated side effects.

Most studies to date have focused on the efficacy of agents to extend block duration, thereby maximizing pain relief for patients receiving a nerve block. However, there are occasions when rapid and effective block reversal is needed. For example, interscalene brachial plexus block for upper extremity surgery frequently causes paralysis of the diaphragm due to inadvertent anesthesia of the phrenic nerve. A method to 'wash out' the local anesthetic around the phrenic nerve in these cases would be beneficial, especially for patients who have pre-existing pulmonary or respiratory diseases. Saline washout of LA may have an additional safety benefit since LAs are myotoxic; reducing the exposure of muscle to LA solutions while maintaining anesthesia would increase the safety of peripheral nerve blocks.

Several studies have demonstrated that epidural washout using normal saline (NS) or Ringer's lactate following epidural block facilitates more rapid recovery of motor function and sensation than letting the block resolve on its own. However, no studies to date have addressed whether washout is effective for reversal of peripheral nerve blocks. Our limited clinical experience suggests that a bolus of NS through a perineural catheter can rapidly and effectively restore phrenic nerve function following interscalene block, and preliminary laboratory experiments indicate that a continuous washout of 0.9% NS reduces by half the time required for normal diaphragm function following injection of lidocaine around the phrenic nerve. Unclear, however, is the mechanism by which NS is able to resolve the block. Thus, the investigators wish to investigate the optimal approach to block reversal and resolution.

Study objective To demonstrate that an infusion of NS can be used in a clinical setting to modify the properties of a nerve block in patients who have received a nerve block for surgery and post-operative analgesia.

Hypothesis The investigators hypothesize that NS can be delivered through a perineural catheter to 'wash out' a nerve block to the point that motor function is restored while maintaining anesthesia of sensory nerve fibers.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Provide informed written consent
  • Adult (≥ 18 years old) patients
  • Scheduled for lower extremity surgery wholly or partially under popliteal sciatic nerve block

排除标准

  • Failure to provide informed consent
  • Infection at the needle insertion site
  • Known coagulopathy
  • Known allergy to local anesthetics
  • Presence of sensory or motor impairment in the distribution of the sciatic nerve prior to nerve blockade
  • Inability to perform valid sensory or motor examination of the function of the sciatic nerve prior to nerve blockade due to impaired access to the limb, language barrier, or inability of the subject to co-operate with such examination

研究组 & 干预措施

Nerve block washout

Experimental

Patients will receive a washout infusion of saline through their perineural catheter to reverse their motor block while maintaining the sensory block.

干预措施: Nerve block washout (Procedure)

Nerve block washout

Experimental

Patients will receive a washout infusion of saline through their perineural catheter to reverse their motor block while maintaining the sensory block.

干预措施: Saline (Drug)

Sham washout

Sham Comparator

Patients will receive an infusion of saline run just enough to maintain catheter patency.

干预措施: Sham washout (Procedure)

Sham washout

Sham Comparator

Patients will receive an infusion of saline run just enough to maintain catheter patency.

干预措施: Saline (Drug)

结局指标

主要结局

Motor function

时间窗: Within 72 hours post-surgery

Motor function (dorsiflexion and plantar flexion) in the absence of pain will be assessed in the period 72 hours following surgery or discharge from hospital, whichever comes first.

次要结局

  • Sensory function(Within 72 hours post-surgery)
  • Patient satisfaction(Within 72 hours post-surgery)
  • Pain(Within 72 hours post-surgery)
  • Time to first oral analgesic(Within 72 hours post-surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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