跳至主要内容
临床试验/NCT00653133
NCT00653133已完成不适用

Multicenter Continuous Peripheral Nerve Block Surveillance Study Comparing Ultrasound Guided Catheter Placement to Non Ultrasound Guided Catheter Placement Techniques

Halyard Health16 个研究点 分布在 1 个国家目标入组 1,821 人开始时间: 2007年5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
入组人数
1,821
试验地点
16
主要终点
Complications of Peripheral Nerve Block

研究概览

简要总结

This two tiered study is a multi-center, open label, surveillance study of the use of continuous nerve blocks with the ON-Q® C-bloc and either nerve stimulator or ultrasound guided continuous nerve block techniques. This study was developed to investigate specific aspects of complication rates related to continuous nerve block techniques in patients undergoing orthopedic surgical procedures.

详细描述

Continuous peripheral nerve block techniques require the placement of catheters near target peripheral nerves. The placement of these catheters is guided by either ultrasound visualization, nerve stimulation or a combination of the two.

This surveillance study was designed to look at the rates of catheter placement related complications with the two techniques.

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

入选标准

  • •Patients having elective orthopedic surgery who are candidates for CPNB as part of their management program for postoperative pain
  • •Able to give consent

排除标准

  • •Morbid obesity (BMI> 40)
  • •Uncooperative or having psychological or linguistic difficulties
  • •Previous damage to the nerve or plexus
  • •Significant comorbidities which the primary investigator feels would limit the quality and collection of data
  • •Allergy to local anesthetic agents including ropivacaine, bupivacaine and lidocaine

研究组 & 干预措施

USPNB

Active Comparator

Ultrasound imaging guided peripheral nerve block

干预措施: Ultrasound imaging (Device)

NSPNB

Active Comparator

Peripheral nerve stimulator guided peripheral nerve block catheter placement for continuous infusion of local anesthetic

干预措施: Peripheral nerve stimulator (Device)

结局指标

主要结局

Complications of Peripheral Nerve Block

时间窗: Preoperative through 3 days post operative

Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (16)

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