跳至主要内容
临床试验/NCT00616044
NCT00616044Unknown不适用

Continuous Spinal Anesthesia Versus Combined Spinal Epidural Block for Major Orthopedic Surgeries. Study Prospective and Randomized.

Sao Jose do Rio Preto Medical School2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2008年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
240
试验地点
2
主要终点
Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries.

研究概览

简要总结

In major orthopaedic surgery of the lower extremities both continuous spinal anesthesia (CSA) and combined spinal epidural anesthesia (CSE) are safe and reliable anaesthesia methods. Our results suggest that both continuous spinal anesthesia and combined spinal epidural anesthesia provide good surgical conditions with a low incidence of complications. The sensory block level and hemodynamic changes were lesser with CSA.

详细描述

240 patients scheduled for hip, knee arthroplasty or fracture of the femur were randomly assigned to receive either CSA or CSE. Blocks were performed in the lateral position at L3-L4 interspace. Puncture success, technical difficulties, paresthesia, highest level of sensory and motor block, need for complementary doses of local anesthetic, degree of technical difficulties, cardiocirculatory changes and post dural puncture headache were registered. At the end of the surgery, the catheter was removed and CSF leak was evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Fractures repair of femur, or arthroplasty of either knee or hip

排除标准

  • Hypovolemia
  • Preexisting neurologic disease
  • Coagulation disorders and/or administration of thromboprophylaxis less than eight hours before the start of surgery
  • Infection at the puncture site
  • Agitation or delirium and the presence of a urinary bladder catheter.

结局指标

主要结局

Comparison between continuous spinal anesthesia versus combined spinal-epidural anesthesia in major orthopedic surgeries.

时间窗: five years

次要结局

未报告次要终点

研究者

发起方
Sao Jose do Rio Preto Medical School
申办方类型
Other

研究点 (2)

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