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临床试验/NCT05086224
NCT05086224进行中(未招募)早期 1 期

Hematoma Block vs. Bier Block: Which is More Effective for Closed Fracture Reduction?

University of Utah1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年7月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
进行中(未招募)
入组人数
500
试验地点
1
主要终点
Visual Analog Scale (VAS) pain

研究概览

简要总结

The investigators objective of this study is to evaluate the effectiveness of hematoma block versus intravenous regional anesthesia (Bier block) during closed reduction of distal radius fractures.

详细描述

The investigators objective of this study is to evaluate the effectiveness of hematoma block compared to intravenous regional anesthesia (Bier block) during closed reduction of distal radius fractures. Distal radius fractures represent one of the most commonly treated skeletal injuries in the US. Achieving a fracture reduction that restores anatomy of the distal radius is of paramount importance. Reductions that re-establish anatomical parameters can prevent a patient from requiring operative intervention for the fracture, eliminating the risks as well as costs that are inherent in undergoing surgery.

Intravenous regional anesthesia (IVRA) or 'Bier block' is an effective technique used to provide anesthesia to the distal extremity. IVRA involves venous infiltration of a local anesthetic with concomitant use of a tourniquet to restrict infiltration solely to the intended extremity. Hematoma block involves local infiltration of local anesthetic directly into the site of a hematoma to provide analgesia. Both IVRA and hematoma blocks can be used to provide analgesia during a variety of procedures including fracture manipulation and reduction, but there is a paucity of data regarding the possible superiority of one means of analgesia.

To date, only a few comparative studies has been performed regarding the use of these two analgesia methods. Numerous investigators have conducted studies evaluating these two methods of analgesia; but these studies were of relatively poor quality, are older (prior to 1995) or did not individually look at all radiographic parameters that are important to orthopedic surgical providers when determining if a distal radius fracture needs surgery, particularly ulnar variance and articular step-off or gapping.

The investigators institution is one of the few in the country that utilizes bier blocks, performed by orthopedic residents, for most closed reductions in the emergency department. This quality makes the investigators institution uniquely qualified and motivated to perform the proposed investigation.

Concerns regarding the implementation of the Bier block surround its' safety profile, including possible increased risk of carpal tunnel, and in more severe cases, seizures or cardiac arrest. Despite the frequency with which investigators manage distal radius fractures, our experience has been that the major complication profile of this technique is minimal. Other studies have supported the notion that catastrophic complications are rare and the most common "complication" is tourniquet pain. These studies are limited by their nature in that anesthesia or emergency medicine providers performed the Bier blocks, while in most instances having the orthopaedic provider perform the block as well as the reduction is more efficient.

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
None

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

  • Adults (age 18+ years of age) with a closed distal radius.
  • Eligible patients will be those who require a closed reduction for a displaced fracture.
  • Any distal radius that falls outside of normal anatomic parameters will require reduction.
  • Normal anatomic parameters include radial inclination: 22°; mean, 19° to 29°, radial height: 11 to 12 mm, and volar tilt 11°; mean,11° to 14.5°.
  • Patients presenting with intact neurovascular exam will be included (sensation intact about ulnar, median, and radial nerve distributions with an intact radial pulse.

排除标准

  • Not able to provide informed consent (intubated or cognitively impaired).
  • Member of vulnerable populations such as non-English speaking and incarcerated patients.
  • Pregnant or lactating women.
  • Have open fractures or altered neurovascular exams.
  • Have any confounding injures such as an associated dislocation or subluxation of the carpus or patients who have a concomitant upper extremity injury requiring surgery.
  • Patients who will obtain follow-up elsewhere (as they will not be able to be studied longitudinally.
  • Patients who have are unable to tolerate the tourniquet pressure while awake or in whom IV access is unable to be obtained in the correct hand will be excluded from the bier block arm of the study.
  • Patients with skin compromise or breakdown or active infection overlying fracture site will be excluded from the hematoma block arm.

研究组 & 干预措施

Hematoma Block

Other

Inject 20 mL of 1% lidocaine without epinephrine into the hematoma site.

干预措施: Hematoma Local Anesthetic Block Procedure with 1% Lidocaine (Drug)

Bier Block

Other

Intravenous administration a maximum lidocaine dose of 3 mg/kg.

干预措施: Bier Anesthetic Block Procedure with 1% Lidocaine (Drug)

结局指标

主要结局

Visual Analog Scale (VAS) pain

时间窗: 30 minutes following fracture manipulation

VAS pain score (0 no pain - 10 severe pain)

次要结局

未报告次要终点

研究者

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

Lucas Marchand

Principle Investigator

University of Utah

研究点 (1)

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