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临床试验/NCT01522053
NCT01522053终止不适用

Comparison of the Catheter-over-needle and Catheter-through-needle Methods for Continuous Delivery of Local Anesthetic During Peripheral Nerve Blockade

University of Alberta2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
54
试验地点
2
主要终点
Incidence of anesthetic/fluid leakage at catheter insertion site.

研究概览

简要总结

When anesthesiologists perform a regional nerve block, they will often put a catheter - a flexible plastic tube - in the patient to allow for continuous delivery of local anesthetic. This allows the nerve(s) to be 'frozen' so that the patient is more comfortable during and after surgery. The most common method of placing the catheter close to a nerve involves threading the catheter through a needle which has been inserted under the skin. Because the catheter is very thin and flexible, it does not thread well through tissue and will buckle and kink when enough force is applied to it. Another problem is that the puncture hole left by the needle is larger than the diameter of the catheter, meaning that when the needle is withdrawn, the catheter is not secure, which increases the chance that it will dislodge and cause leakage of local anesthetic. One solution to these problems is to use a catheter placement method similar to how intravenous catheters are installed. In this method, the catheter fits around ('over') the needle, which results in more support for the catheter while it is being pushed under the skin. We wish to examine if a catheter-over-needle method would be useful for placing a catheter to deliver local anesthetic during peripheral nerve blockade. We will compare the catheter-over-needle method to the currently used catheter-through-needle method on patients who require continuous anesthetic delivery for their surgery; half the patients will receive anesthetic through one method, and the other half will receive anesthetic through the other method. We believe that using the catheter-over-needle method will result in more secure placement of the catheter and more efficient delivery of local anesthetic.

详细描述

Background: Current needle-catheter assemblies are designed so that a flexible catheter is threaded through a larger diameter needle towards a target nerve. These catheter-through-needle (CTN) assemblies suffer from several fundamental problems, including leakage at the insertion site and dislodgement of the catheter. The underlying problem of this design is that the needle puncture hole is wider in diameter than the catheter diameter. An alternative catheter-over-needle (CON) design, in which the catheter diameter is larger than that of the needle puncture hole, may be a potential solution to the problems of leakage and dislodgement. We wish to evaluate the ease of use and effectiveness of the CON method in the clinical setting by having anesthesiologists perform and rate the two techniques during and after administration of local anesthesia at various block sites on the body.

Study objective: To compare the ease of use and effectiveness of the CON technique to the CTN method in delivering continuous local anesthesia during regional nerve blockade.

Hypothesis: Insertion of a CON assembly catheter will result in more secure and accurate catheter placement and more efficient delivery of local anesthetic compared to a catheter placed using the CTN method.

Primary outcomes:

  1. Time taken to place catheter near target nerve after initial skin puncture.
  2. Confidence in accurate catheter placement.
  3. Assessment of catheter stability at insertion site.
  4. Incidence of anesthetic/fluid leakage at catheter insertion site.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (>18 yrs)
  • Scheduled for surgery that requires continuous peripheral nerve block

排除标准

  • Failure to provide informed consent
  • Allergy to local anesthetic
  • Neurological pathology and/or deficit in the block region

结局指标

主要结局

Incidence of anesthetic/fluid leakage at catheter insertion site.

时间窗: Duration of time that perineural catheter is in the patient

Evidence of leakage of local anesthetic at the catheter insertion site and any catheter dislodgement or premature withdrawal will be recorded.

次要结局

  • Time taken to place catheter near target nerve after initial skin puncture.(From identification of needle insertion site to correct placement of needle in patient; approximately 2 minutes.)
  • Confidence in accurate catheter placement.(Duration of catheter placement in patient.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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