临床试验/ChiCTR1900027410

ChiCTR1900027410尚未招募Unknown

A Randomized Control Trial Comparing the Clinical and Postoperative Outcomes in Ankle Fixation managed under wide-awake local anesthesia versus spinal anesthesia

未提供1 个研究点分布在 1 个国家目标入组 149 人开始时间: 2016年2月9日最近更新: 2019年11月12日

试验速览

阶段: Unknown
状态: 尚未招募
入组人数: 149
试验地点: 1
主要终点: Postoperative Pain Score

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To compare the postoperative pain levels between WALANT (Wide-awake local anesthesia with no tourniquet) patients undergoing ankle fracture fixation and spinal anesthesia patients. To document the intraoperative experience of the patient undergoing WALANT. To compare the clinical outcomes and patient satisfaction at 1 year after surgery.

研究设计

研究类型: Interventional
主要目的: 半随机对照
盲法: Double

入排标准

年龄范围: 18 至 60（—）
性别: All

入选标准

•Ankle fractures operated within 10 days of the initial injury;
•Ankle fractures OTA/AO classification 44B1, 44B2, 44B3 44C1, 44C2 and 44C3;
•Aged 18-60 years.

排除标准

•Patients that did not consent for WALANT;
•Patients that did not consent for participation in the trial;
•Ankle fractures with posterior malleolus requiring fixation;
•Open Ankle Fractures;
•Patients that did not follow up till 1 year;
•Anxious patients;
•Lidocaine hypersensitivity;
•Peripheral vascular disease.

研究组 & 干预措施

1

WALANT

2

Spinal Anesthesia

结局指标

主要结局

Postoperative Pain Score

时间窗: 24 hours after surgery

Clinical Outcome

时间窗: 1 year

Clinical Outcome

时间窗: Fracture Union

Blood loss

时间窗: Intraoperative

次要结局

Patient Satisfaction(1 year)

研究者

发起方

未提供

研究点 (1)

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