跳至主要内容
临床试验/NCT02235506
NCT02235506Unknown不适用

A Comparison of Epidural Analgesia With Adding Sciatic Nerve Block to Continuous Femoral Nerve Block for Post-operative Pain Management Following Total Knee Arthroplasty

Yeungnam University College of Medicine1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
the incidence of side effects

研究概览

简要总结

The investigators compared continuous epidural infusion with combined continuous femoral and single-shot sciatic nerve blocks. The primary outcome was the incidence of side effects, and secondary outcomes were pain relief, motor blockade,morphine consumption, and rehabilitation indices.

详细描述

The parcicipants were randomly assingned to epidural infusion group and femoral sciatic block. In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation. In femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr. The incidence of side effects is measured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •American Society of Anesthesiologists Physical Status Classification I-II
  • •total knee arthroplasty
  • •18-90 years

排除标准

  • •allergic to the local anesthetics
  • •cognitive impairment such as dementia
  • •coagulopathy
  • •motor and sensory impairment
  • •patient refusal

研究组 & 干预措施

epidural infusion

Experimental

In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation,

干预措施: epidural infusion (Procedure)

epidural infusion

Experimental

In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation,

干预措施: epidural infusion (Device)

femoral sciatic

Experimental

In femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr.

干预措施: femoral sciatic (Procedure)

femoral sciatic

Experimental

In femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr.

干预措施: femoral sciatic (Device)

结局指标

主要结局

the incidence of side effects

时间窗: during 5 days after the end of operation

Side effects: The patients were asked to their experience of dizziness, sedation, nausea/vomiting (PONV), and pruritus. Urinary retention: bladder volume was measured by ultrasonography and if the volume was more than 400 mL and if the patient was unable to void spontaneously, single catheterization was performed.

次要结局

  • Pain(during 5 days after the end of operation)
  • Motor blockade at rest and on mobilization(during 5 days after the end of operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sangjin Park

assistant professor

Yeungnam University College of Medicine

研究点 (1)

Loading locations...

相似试验