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临床试验/NCT00178750
NCT00178750撤回1 期

A Randomized Clinical Comparison of the "Loss of Resistance" Technique Versus the CompuFlo® Computerized Syringe Pump for Proper Epidural Placement

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家开始时间: 2005年9月15日最近更新:
适应症

试验速览

阶段
1 期
状态
撤回
试验地点
2
主要终点
Number of attempts

研究概览

简要总结

The purpose of this study is to compare how well the CompuFlo® computerized syringe pump works as compared to the traditional method of inserting an epidural (a needle placed in one's back to give pain medicine).

详细描述

It is possible to utilize epidural anesthesia as the sole anesthetic technique for thoracic, abdominal, and lower extremity surgeries, as a method of postoperative pain management after surgery, and for pain relief during labor and delivery. However, despite the various benefits of epidural anesthesia, this procedure is not utilized to its maximum potential in the operating room. One reason for inadequate utilization of this procedure is the difficulty in properly identifying the epidural space. Current techniques for identifying the epidural space rely on the subjective perception of the operator on loss of resistance to air or saline as the needle passes from the ligamentum flavum into the epidural space. CompuFlo®'s pressure-sensing technology provides an objective measurement for proper placement of the epidural.

Very little advancement has been made in improving training to identify the correct location of the epidural space. Epidural anesthesia has a relatively higher failure rate when performed by residents in training. The skills of trainees differ greatly, and there are no standard teaching methods to teach epidural anesthesia. Statistical analysis conducted by Naik et al. concluded that some residents may need as many as 75 attempts at epidural anesthesia to ensure proficiency.

The CompuFlo® is a computerized syringe pump capable of volume and pressure-controlled infusion. It has a pressure sensor and a mathematical algorithm capable of determining the pressure at the needle tip. Pressures are continuously monitored and displayed, which are reflected by acoustic changes in tone. A dramatic pressure decrease and a high tissue compliance (pressure does not increase despite continuous infusion) signifies entrance into the epidural space. Combining a program with a low upper pressure limit and a high infusion rate mimics the technique used by the loss of resistance with saline proponents (constant pressure on the plunger). It combines the "feel" of inserting an epidural needle with the visualization of the pressure level, as well as a sound indicator to indicate proper placement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Any obstetric patient presenting for vaginal delivery desiring epidural anesthesia
  • American Society of Anesthesiologists (ASA) Physical Classification I-III
  • Aged 18-65 years

排除标准

  • Obstetric patients presenting for Cesarean section
  • American Society of Anesthesiologists Physical Classification ≥ IV
  • Contraindications for epidural anesthesia
  • Allergy to local anesthetics

结局指标

主要结局

Number of attempts

Incidence of incorrect epidural placement

Pain level 1-10

次要结局

  • Subjective difficulty in placing epidural

研究者

研究点 (2)

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