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临床试验/NCT01485653
NCT01485653已完成不适用

Effective Low Dosage of Mepivacaine in Ultrasound Guided Axillary Block in Patients Undergoing Distal Upper Extremity Surgery

Wayne State University0 个研究点目标入组 64 人开始时间: 2010年4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
已完成
入组人数
64
主要终点
Successful Block

研究概览

简要总结

The use of ultrasonography as an adjunct to regional anesthesia has significantly increased in recent years. Brachial plexus blockade by an axillary approach is amenable to the use of ultrasound guidance. Real time sonography of nerve structures ensures an optimal distribution of the block solution. When compared to other methods of nerve localization, sonography decreases: failure rate procedure time and the onset time for blockade. Furthermore, the use of ultrasound for peripheral nerve blockade demonstrates decreased procedure related complications such as nerve injury and unintentional vascular puncture.

Traditional axillary block techniques relying on surface anatomical landmarks require large volumes of local anesthetic, generally 40mL and greater. Utilizing the increased accuracy offered by ultrasound, some studies have shown that low volumes of local anesthetic can yield successful axillary plexus blockade. Therefore, the tradition of using large volumes of local anesthetic for axillary blocks, even without ultrasound, may not be warranted.

Although recent investigations support using a low volume of local anesthetic for brachial plexus blockade, there is a lack of outcome data from blinded randomised trials. The primary objective of this study was to evaluate 2 different volumes of local anesthetic for axillary blockade: 1) 20mL or 2) 30 mL. For the 2 different volumes used in this study, a 1.5% solution of mepivacaine was chosen due to its widespread clinical use in axillary blocks, which is secondary to: rapid onset of action, intermediate duration of effect, and relative low cost. The primary outcome was block success rate for outpatients undergoing distal upper limb surgery. Secondary objectives included comparing the 2 volumes with respect to: time required to perform the block, and onset of sensory and motor blockade.

详细描述

Introduction

The use of ultrasonography as an adjunct to regional anesthesia has significantly increased in recent years. Brachial plexus blockade by an axillary approach is amenable to the use of ultrasound guidance. Real time sonography of nerve structures ensures an optimal distribution of the block solution. When compared to other methods of nerve localization, sonography decreases: failure rate procedure time and the onset time for blockade. Furthermore, the use of ultrasound for peripheral nerve blockade demonstrates decreased procedure related complications such as nerve injury and unintentional vascular puncture.

Traditional axillary block techniques relying on surface anatomical landmarks require large volumes of local anesthetic, generally 40mL and greater. Utilizing the increased accuracy offered by ultrasound, some studies have shown that low volumes of local anesthetic can yield successful axillary plexus blockade. Therefore, the tradition of using large volumes of local anesthetic for axillary blocks, even without ultrasound, may not be warranted.

Although recent investigations support using a low volume of local anesthetic for brachial plexus blockade, there is a lack of outcome data from blinded randomised trials. The primary objective of this study was to evaluate 2 different volumes of local anesthetic for axillary blockade: 1) 20mL or 2) 30 mL. For the 2 different volumes used in this study, a 1.5% solution of mepivacaine was chosen due to its widespread clinical use in axillary blocks, which is secondary to: rapid onset of action, intermediate duration of effect, and relative low cost. The primary outcome was block success rate for outpatients undergoing distal upper limb surgery. Secondary objectives included comparing the 2 volumes with respect to: time required to perform the block, and onset of sensory and motor blockade.

Methods

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

入选标准

  • Orthopedic forearm, wrist and hand surgery
  • ASA I-III
  • block procedure time less than 6 minutes
  • pre-block sedation using less than 2 mcg fentanyl and less than .04 mg midazolam,
  • patient consent to light pre-op sedation

排除标准

  • Elbow/arm surgery longer than 2 hours
  • BMI greater than 35
  • Pregnant patients
  • history of CVA or scarring in the axillary to elbow area
  • history of neurological impairment of either upper extremity
  • Any allergies to local anesthetics coagulopathy,
  • infection at the site of block
  • patients requiring opioid therapy for chronic pain

研究组 & 干预措施

Mepivacaine, Ultrasound Axillary Block

Experimental

Group 1) 20mL 1.5% mepivacaine Group 2) 30mL 1.5% mepivacaine

干预措施: Mepivacaine (Drug)

结局指标

主要结局

Successful Block

时间窗: 30 minutes

Definitions of successful block Functional successful block: Sensory score of 0-1 in all 4 territories and motor score of 0-1 in 3 of 4 territories within 30 minutes of needle extraction. Surgical successful block: no required intraoperative supplemental local anesthetic, light sedation \<25mcg/kg/min propofol and absence of general endotracheal anesthesia.

次要结局

  • Time required until onset of sensory blockade.(30 minutes)
  • Time taken until Onset of Motor Blockade(30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samuel Perov

Dr Samuel Perov

Wayne State University

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