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临床试验/NCT04618107
NCT04618107已完成不适用

Principal Investigator

Dow University of Health Sciences2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
2
主要终点
active range of motion

研究概览

简要总结

Wide awake surgery for tendon repair in hand trauma To compare the functional outecomes in terms of active range of motion for tendon repair surgeries performed under wide awake anaesthesia versus general anaesthesia.

详细描述

All patients aged 15 or above with hand trauma resulting in tendon injuries were included.65 patients undergoing tendon repair in wide awake anaesthesia were grouped as approach arm and another 65 patients of general anaesthesia group were kept as control arm.Range of motion of corresponding tendons were measured at completion of sixth postoperative week using goniometer.Total active range of motion were calculated according to criteria given by Strickland method and American Society for Surgery ofthe Hand (ASSH).

Functional outcomes were compared among two groups.

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of either gender of age 15 years or above.
  • All of the patients with hand injuries with tendon repair required, operated within the hospital premises

排除标准

  • Patients allergic to agents of local anesthesia.
  • Patients with anxiety symptoms
  • Patients with mental disorders rendering them unable to comprehend and follow intraoperative commands.
  • Patients with associated nerve injuries.
  • Patients requiring bone fixation or with other complex injuries and with soft tissue loss requiring coverage.
  • Patients with massive contamination, crush injuries or infection which needs to be addressed and treated prior to definitive repair.

结局指标

主要结局

active range of motion

时间窗: six weeks

active range of motion assesd by strickland and American Society for surgery criteria

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

Saba Kiran

Principal investigator

Dow University of Health Sciences

研究点 (2)

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