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临床试验/NCT01376960
NCT01376960已完成4 期

Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures: A Prospective Comparison

OrthoCarolina Research Institute, Inc.2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
202
试验地点
2
主要终点
Conversion to general anesthesia following either a single shot popliteal fossa block or ankle block

研究概览

简要总结

The purpose of this study is to compare, for the first time ever, single shot popliteal fossa blocks to ankle blocks as primary anesthesia for patients undergoing forefoot procedures. The primary outcome variable for this study is the percentage of patients that convert to general anesthesia following either a single shot popliteal fossa block or ankle block.

H0: There is no difference in the percentage of patients that convert to general anesthesia between single shot popliteal fossa blocks and ankle blocks.

HA: There will be a lower percentage of patients receiving a single shot popliteal fossa block that convert to general anesthesia compared to patients receiving an ankle block.

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

性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective forefoot surgery, including both soft-tissue and osseous procedures

排除标准

  • Any form of Peripheral neuropathy
  • Known allergy to local anesthesia
  • Active infection

结局指标

主要结局

Conversion to general anesthesia following either a single shot popliteal fossa block or ankle block

时间窗: Participants will be followed for the duration of the surgery, an expected average of 2 hours

Popliteal fossa and ankle blocks are types of anesthesia used during surgery. If these methods are not effective as an anesthetic during surgery the anethesiologist will convert to general anesthesia.

次要结局

  • Visual Analog Pain Scale (VAS)(24 hours postoperatively)
  • Patient Satisfaction(48 hours postoperative)
  • Length of Post Anesthesia Care Unit (PACU) stay(Up to 6 hours postoperative)
  • Narcotic Use(Up to 30 days postoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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