跳至主要内容
临床试验/NCT01973699
NCT01973699已完成不适用

Surgeon Determined Visualization in Shoulder Arthroscopy: A Randomized, Blinded, Controlled Trial Comparing Irrigation Fluid With and Without Epinephrine

St. Luke's Hospital, Pennsylvania2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2012年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
83
试验地点
2
主要终点
Visualization

研究概览

简要总结

Adequate visualization during shoulder arthroscopy is of great importance for the procedure to be efficiently and effectively performed. The use of dilute epinephrine in irrigation fluid has been historically utilized to help with visualization. Given the potential safety issues documented in the literature related to epinephrine use, as well as the significant improvements in technique and instrumentation over the last decade, the need for this additive should be reexamined. The objective of the current study was to compare surgeon determined visualization in shoulder arthroscopy using irrigation fluid with and without epinephrine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • All patients requiring shoulder arthroscopy

排除标准

  • 未提供

研究组 & 干预措施

With Epinephrine

Placebo Comparator

Patients undergoing shoulder arthroscopy with epinephrine in their irrigation as standardly performed

干预措施: visualization in shoulder arthroscopy (Other)

Without Epinephrine

Experimental

Patients undergoing shoulder arthroscopy without epinephrine in their irrigation fluid as typically done

干预措施: visualization in shoulder arthroscopy (Other)

结局指标

主要结局

Visualization

时间窗: November 1, 2012- April 1, 2013 (5 months)

surgeon determined visualization during shoulder arthroscopy as judged by a VAS

次要结局

  • Fluid Use(November 1, 2012-April 1, 2013 (5 months))
  • Operative time(November 1, 2012-April 1, 2013 (5 months))

研究者

发起方
St. Luke's Hospital, Pennsylvania
申办方类型
Other
责任方
Sponsor

研究点 (2)

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