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临床试验/NCT04549441
NCT04549441Unknown不适用

Prospective Observational Study Comparing General Anesthesia and Wide-Awake Anesthesia No Tourniquet (WALANT) for Distal Radius Fracture Open Reduction and Plating Fixation Surgery

Kaohsiung Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Heart rate

研究概览

简要总结

The wide-awake local anesthesia no tourniquet (WALANT) has been widely used in the field of hand surgery in recent years. This surgical method has progressed to open reduction and internal fixation of distal radial fracture and radial or ulnar shaft fractures. However, there are still many unclear points for clinicians, including the perioperative subjective feedback from the patient and changes in postoperative pain. In this study, participants having forearm fractures should undergo open reduction and internal fixation were randomized to general anesthesia or WALANT. The investigators will compare the differences in perioperative subjective and objective assessments of these participants during surgery, as well as the prognosis and function after surgery.

详细描述

  1. Written informed consent must be obtained before any study-specific procedures are undertaken.
  2. The process of the experiment A. Include participants into this study, they will be randomized into general anesthesia or WALANT group B. The maximum (toxic) dose of lidocaine was 7 mg/kg. Make distal radius fracture for an example, the solution used in the WALANT technique consisted of 20 ml of 2% lidocaine with epinephrine 1:50,000, which were mixed with normal saline to give a total of 40 ml. A set of baseline parameters, including pulse oximetry, respiratory rate, heart rate, blood pressure, respiratory rate, and oxygen saturation, was obtained during the entire surgery. At the same time, preoperative intravenous antibiotics with 1 g cefazolin were given for each patient as prophylaxis. The amount of blood loss was based upon the amount in a suction container in the operation room. In addition, the investigators will measure the participant's intraoperative subjective satisfaction and pain assessment.

C. After surgery, the participant needs to stay in the in-patient department for one day. The investigators will provide routine prophylactic antibiotics and oral pain pillar. Postoperative pain, sensory, and motor function assessment.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a mature skeleton having a radial fracture

排除标准

  • Patients having multiple trauma and need to undergo open reduction and internal fixation surgery
  • Patients having a concomitant intracranial injury
  • Pathological fracture
  • Patients refused to be randomized into general anesthesia or WALANT group
  • Patients have a history of allergy to anesthetic drugs

结局指标

主要结局

Heart rate

时间窗: The outcome will be measured intraoperatively.

Intraoperative heart rate

Blood pressure

时间窗: The outcome will be measured intraoperatively.

Intraoperative mean arterial pressure

次要结局

  • Pain scale(The NRS was recorded in seven times perioperativley, namely before surgery (T0) and at the time of injection of local anesthesia (T1), skin incision (T2), fracture reduction (T3), plating and screwing (T4), skin closure (T5), and surgery completion (T6).)

研究者

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

Wen-Chih Liu

Attending surgeon

Kaohsiung Municipal Hsiaokang Hospital

研究点 (1)

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