Ultrasound Guidance or Electrical Nerve Stimulation for Interscalene Brachial Plexus Block: a Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Onset time of brachial plexus anesthesia
研究概览
简要总结
This study has been designed to assess the possible advantages of using ultrasound imaging to block the brachial plexus (i.e., nerves of the upper limb) in patients undergoing shoulder surgery.
The ultrasound technique will be compared with the current gold standard, electrical nerve stimulation.
The aim of this study is to define which technique is better in terms of time to onset of anesthesia.
详细描述
The study will compare real-time ultrasound (US) guidance and electrical nerve stimulation (ENS) in terms of onset time for interscalene brachial plexus anesthesia.
The main hypothesis is that direct visualization of neural structures under US guidance will grant better local anesthetic (LA) disposition around the roots of the plexus, thus improving onset times.
Perineural catheters will be used to maintain regional analgesia for 48 hours after surgery. We hypothesize that US guidance may also help physicians place perineural catheters more precisely, thus improving analgesia in the following hours to days.
Finally, we will investigate for possible differences in minor adverse events such as vascular puncture, pain during the anesthetic procedure.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Physical Status Class I-III
- •Elective surgery of the shoulder
- •Informed consent to regional anesthesia
排除标准
- •Inability to effectively communicate
- •Chronic opioid use
- •Absence of informed consent to participation to the study
- •Ipsilateral upper limb neurological deficits
- •Known allergy to study medications
- •Contraindications to continuous block placement
研究组 & 干预措施
US Group
In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
干预措施: Ultrasound-guided continuous interscalene brachial plexus block (Procedure)
US Group
In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
干预措施: Ropivacaine (Drug)
US Group
In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
干预措施: Paracetamol (Drug)
US Group
In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
干预措施: Morphine (Drug)
US Group
In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
干预措施: Fentanyl (Drug)
US Group
In this group, the continuous block will be performed under real-time ultrasound (US) guidance.
干预措施: General anesthesia (Procedure)
ENS Group
In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
干预措施: Continuous interscalene brachial plexus block using electrical nerve stimulation (Procedure)
ENS Group
In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
干预措施: Ropivacaine (Drug)
ENS Group
In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
干预措施: Paracetamol (Drug)
ENS Group
In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
干预措施: Morphine (Drug)
ENS Group
In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
干预措施: Fentanyl (Drug)
ENS Group
In this group, the continuous block will be performed with an electrical nerve stimulation (ENS) technique.
干预措施: General anesthesia (Procedure)
结局指标
主要结局
Onset time of brachial plexus anesthesia
时间窗: ≤30 min
次要结局
- Successful brachial plexus anesthesia(≤30 min)
- Additional analgesic requirements during surgery(Duration of surgery)
- Incidence of paresthesiae during the anesthetic procedure(≤30 min)
- Incidence of blood aspiration during the anesthetic procedure(≤30 min)
- Number of needle redirections for the performance of the block(≤30 min)
- Pain during performance of the block(≤30 min)
- Pain at rest and on movement (visual analog scale)(q8h until 48 h after surgery)
- Local anesthetic consumption on patient-controlled pump(≤48 h)