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临床试验/NCT05832021
NCT05832021已完成不适用

Comparison of Patients With Distal Radius Fracture Who Underwent Surgery With WALANT Technique or Peripheral Nerve Block Anesthesia Methods in Terms of Patient Satisfaction and Functional Results in the Postoperative Period

Diskapi Yildirim Beyazit Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Changes in the patient's anxiety

研究概览

简要总结

WALANT anesthesia technique has been frequently preferred in hand and upper extremity surgery in recent years. WALANT technique; It stands out with its advantages such as lack of pre-operative anesthesia preparation process, reduction in test and examination requests, reduction in unnecessary hospitalizations and high patient satisfaction. There are studies with a high level of evidence showing that the WALANT technique has such advantages in soft tissue and smallmedium bone fracture surgery. In large bone fractures (radius, etc.), surgical treatment is performed with the WALANT technique and positive results have been reported. Although there is a study comparing WALANT and general anesthesia in the surgical treatment of distal radius fractures, there is no study comparing the peripheral nerve block technique.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 years of age
  • Patients who had acute distal radius fracture which underwent surgery

排除标准

  • Patients with open fractures
  • Additional injuries in the same extremity, peripheral vascular disease, and local anesthetic allergy at the time of first admission
  • Patients who are switched to general anesthesia after both techniques
  • Patients who underwent a second surgery on the same extremity due to any complication
  • Patients who had lacked follow-up examination information

结局指标

主要结局

Changes in the patient's anxiety

时间窗: Baseline, immediately after the surgery, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery

State-Trait Anxiety Inventory (STAI-TX) (no anxiety: 1 point, a little anxiety: 2 points, anxious: 3 points, very anxious: 4 points) to measure anxiety

Changes in the patient's pain

时间窗: Baseline, immediately after the surgery, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery

Visual Analogue Scale (VAS) scale (1 to 10 score. 10 means worst pain possible, 1 is almost no pain) to measure pain level

次要结局

  • Number of complications after surgery(Collected at end of follow up (24 months))
  • Description of reason why the patient needed adding some extra anaesthesia if necessary due to lack of effectiveness of the main anaesthetic technique(During surgery (intraoperative))
  • Evolution in postoperative wrist mobility(Baseline, 2 weeks after surgery, 6 weeks after surgery, 12 weeks after surgery, 24 weeks after surgery)
  • Number of patients who need conversion to general anaesthesia due to lack of effectiveness of anaesthetic technique(During surgery (intraoperative))
  • Type of anaesthetic technique added to solve the lack of effectiveness of the main anaesthesia(During surgery (intraoperative))

研究者

发起方
Diskapi Yildirim Beyazit Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Huseyin Bilgehan Cevik

MD, Assoc Prof

Diskapi Yildirim Beyazit Education and Research Hospital

研究点 (1)

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