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临床试验/NCT01662154
NCT01662154终止不适用

Percutaneous Nerve Stimulation as a Means to Assess Nerve Block Effectiveness

University of Alberta2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
35
试验地点
2
主要终点
Accuracy of nerve activity measurement.

研究概览

简要总结

Anesthetizing nerves in the extremities is an effective way to freeze an area in preparation for surgery. The doctor injects local anesthetic in an appropriate area, interrupting signals from nerves in that area that control movement and sensation. Depending on how much anesthetic is injected, the doctor can impair both movement and sensation or sensation alone. Currently, there are a few methods used to determine how much sensation a patient has in an area, such as testing the patient's response to a pinprick or cold sensation on the skin. Unfortunately, these methods are subjective and don't always give an accurate measurement of how extensive the block is. For this reason, a more accurate and objective method of assessing nerve blocks is needed. We wish to perform a study to test two nerve stimulation devices to compare their ability to give adequate measurements of nerve activity before and after local anesthesia. If we find that a common nerve stimulator can consistently give accurate readings of nerve activity, anesthesiologists may be able to use this device to determine how well a nerve block is working and adjust the patient's anesthesia accordingly.

详细描述

Background and rationale Peripheral nerve blocks (PNBs) are highly effective methods of anesthetizing regions of the body for surgery. Throughout its history, the field of regional anesthesiology has lacked an objective, quantitative tool for assessing the effectiveness of a given block. Current methods for assessing blocks are mainly subjective and rely on patient feedback to determine how well a nerve is blocked; these methods include 1) sensory tests, such as ability to detect a pinprick or cold sensation, 2) motor tests, for example, ability to flex or extend the body part that has been blocked, and 3) verbal feedback by the patient. Although these methods usually provide a satisfactory assessment of the block, an objective tool that could decisively and consistently determine how well a nerve is blocked would avoid the ambiguity inherent to the subjective tests and may allow anesthesiologists to more precisely control pain during and after surgery.

Nerve stimulation technology represents one possible method for objectively assessing PNBs by eliciting paresthesia in the region of the body undergoing blockade. Nerve stimulation devices operate by sending an electrical current to a nerve, depolarizing it, and eliciting muscle contraction or paresthesia, depending on the type of nerve stimulated (motor or sensory, respectively). In theory, patients may exhibit a higher current perception threshold in regions of the body that have been anesthetized. Several nerve stimulation devices are commercially available, although they vary in cost, setup, and features. The Neurometer diagnostic stimulator is a percutaneous nerve stimulation device that records sensory nerve conduction thresholds and is commonly used to diagnose neuropathies associated with conditions such as carpal tunnel syndrome, diabetes, and spinal cord lesions. The Neurometer generates constant alternating current sinusoid waveform stimuli at three different calibrated frequencies: 2000 Hz, 250 Hz, and 5 Hz with a range of stimulus output intensities from 0.01 to 9.99 milliAmperes (mA). The current is delivered to the skin surface via a pair of 1 cm diameter gold electrodes separated by 1.7 cm.

Other devices, such as peripheral nerve stimulators, are commonly connected to insulated needles or stimulating catheters to locate nerves to be blocked. When connected to a surface electrode probe, a peripheral nerve stimulator delivers an electric current that elicits motor or sensory activity as the current stimulates the appropriate target nerve. The device generates square pulses with selectable stimulus duration and continuously adjustable stimulation current. The pulse current can be adjusted to appropriate levels, allowing extremely precise adjustments of the stimulation current. The stimulation frequency and stimulus duration can be varied for different applications. The nerve stimulator features the option of selecting a frequency of 1 Hz or 2 Hz for sequential electrical nerve stimulation and stimulus duration of 0.05 milliseconds (ms) to 1 ms.

Although the Neurometer represents the gold standard in percutaneous nerve stimulation, it is expensive, making it impractical for use in everyday clinical applications. We hypothesize that a common peripheral nerve stimulator device can be used as a functional substitute for the Neurometer in generating a sensory stimulus to assess PNB effectiveness. The aim of this study is to compare the Neurometer and a common nerve stimulator to assess anesthesia following PNB. We predict that the nerve stimulator can be used successfully as a substitute for the Neurometer in assessing PNBs in patients receiving regional anesthesia of the extremities.

Study objective To compare the Neurometer and a common peripheral nerve stimulator in measuring current perception threshold in patients receiving PNB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (18 years of age or older) patients who have provided informed consent.
  • Outpatients scheduled for elective surgery on the upper or lower extremity or abdomen.
  • Requirement for nerve block.

排除标准

  • Failure to provide informed consent.
  • Neuropathic lesions or polyneuropathic conditions.
  • Implanted electrical devices (e.g., pacemaker, spinal cord or peripheral nerve stimulator).
  • Allergy to local anesthetics.
  • Severe coagulopathy.
  • Bilateral upper limb surgery.

结局指标

主要结局

Accuracy of nerve activity measurement.

时间窗: During nerve stimulation (approximately 30 seconds for each stimulation test)

Testing whether a common nerve stimulator device detects nerve activity as accurately and consistently as the Neurometer.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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