跳至主要内容
临床试验/NCT07083934
NCT07083934尚未招募不适用

Comparison of Ultrasound Guided Supraclavicular Brachial Plexus Block With and Without Peripheral Nerve Stimulation (PNS) Guidance: A Randomized Controlled Tria

Aga Khan University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
44
试验地点
1
主要终点
Success rate of peripheral nerve block (PNB) with ultrasound-guided regional anesthesia (UGRA) with and without peripheral nerve stimulation (PNS)

研究概览

简要总结

Peripheral Nerve Blockade (PNB) became reliable with the advent of Ultrasound (US) and Peripheral Nerve Stimulation (PNS).

US offers real-time visualization but has limitations, especially with deep or obscured nerves.

PNS complements US by confirming nerve proximity through motor responses. Combining both may enhance safety and success of nerve blocks. This study compares US-guided blocks with and without PNS in a randomized trial.

详细描述

Peripheral Nerves Blockade (PNB) via local anaesthetics is a method of providing anesthesia and analgesia to the limbs and it was well established in the late 20th century. However, it did not come very well into practice because of unreliability, high rate of complications and failure due to lacking of accurate and reliable techniques of nerve localization at that point in time. It was only when newer nerve localization methods, such as Peripheral Nerve Stimulation (PNS) and Ultrasound (U/S) Imaging started becoming commercially available that the trend of Regional Anaesthesia started getting recognized among the physicians. PNB as a sole anaesthesia technique for limb surgery took further integration in practice and widespread acceptance among anaesthetist in the last decade, once ultrasound technology advanced to newer heights resulting in compact and more mobile units, higher resolution, needle recognition software etc.

When compared to PNS guided regional anaesthesia (PGRA), ultrasound guided regional anaesthesia (UGRA) offers a number of important practical advantages such as direct real-time visualization of the anatomy of interest, needle pathway and its passing through structures and spread of local anaesthetic, and the potential for instantaneous needle re-adjustments as per need. All this allows for safer and more effective distribution of local anaesthetic in the region of desired peripheral nerve. This superiority of Ultrasound Guidance led to fade in the use of PNS guidance in the Regional Anaesthesia practice over the recent years.

Regardless of the previously discussed superiority of U/S Guidance in Regional anaesthesia (RA), it has its own limitations. Such limitations include difficulty in visualization and identifying neural structures when they are lying far away from the skin either due to thick overlying subcutaneous adipose tissue in the obese patients or simply because of the presence of nerve bundle in the deeper tissue planes, and inability to confidently identify and exclude the placement of needle tip within the nerve, where if an injectate is injected will lead to nerve damage.

Such limitations of U/S Guidance in RA can be circumvented by using PNS Guidance in its conjunction. PNS works by delivering a small pulse of electric current through the needle tip which when in close proximity to a neural structure will lead to its stimulation and its respective muscle contraction, thereby helping us in identifying the neural structure of interest. Current density (with pulse duration at 1ms and frequency 2Hz) of around 1 mA for superficial nerves and 1.5-2mA for deeper nerves is enough to elicit a desired motor response. Eliciting a motor response at an even higher current density can be discomforting to the patient as well as misleading to the operator as neural structures can get stimulated through tissues and fascial planes. Similarly, Current density can also be used to predict the intra-fascicular or intraneural needle placement. One study showed that minimum stimulation (Median [interquartile range]) threshold outside was 0.60 mA [0.40-1.0] and inside 0.30 mA [0.20-0.40], where, the difference of 0.30 mA was statistically significant. Therefore, a lower limit for the current density can be used as a safety margin beyond which no muscle activity should be elicited by using PNS.

So, considering the additional benefits of PNS Guidance that it can potentially concur in facilitating UGRA in achieving effective and safer PNB, we propose and design a randomized control trial by comparing the UGRA with and without PNS Guidance in achieving PNB and its outcomes.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Aged 18 years and older
  • •ASA physical status I to IV
  • •No contraindications to regional anaesthesia
  • •Operative site located at the mid to lower arm, including the elbow, forearm, wrist, or hand
  • •Ability to provide informed consent
  • •Ability to reliably report symptoms to the research team related to regional anaesthesia

排除标准

  • •Patient's refusal to participate.
  • •Inability to provide first-party consent due to cognitive impairment.
  • •Cognitive dysfunction which can lead to difficulties in communication and cooperation of patient.
  • •Preexisting neuropathy.
  • •Preexisting coagulopathy.
  • •Patients who will be shifted to ICU due to post - operative ventilatory support.

研究组 & 干预措施

Ultrasound (US)

Active Comparator

Use of an ultrasound guidance device without a peripheral nerve stimulator for nerve block placement. Only ultrasound will be used for the procedure.

干预措施: No peripheral nerve stimulator (Device)

Ultrasound+PNS

Experimental

Use of a peripheral nerve stimulator device in combination with ultrasound for nerve block placement.

干预措施: Peripheral nerve stimulator (Device)

结局指标

主要结局

Success rate of peripheral nerve block (PNB) with ultrasound-guided regional anesthesia (UGRA) with and without peripheral nerve stimulation (PNS)

时间窗: From administration of peripheral nerve block (PNB) until confirmation of successful block onset, assessed up to 60 minutes post-procedure

Comparison of PNB success rate between UGRA alone and UGRA combined with PNS guidance.

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 (1)

Loading locations...

相似试验