跳至主要内容
临床试验/NCT00996905
NCT00996905已完成不适用

Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion of Labour Epidural Catheters

Samuel Lunenfeld Research Institute, Mount Sinai Hospital2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2009年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
试验地点
2
主要终点
Ease of epidural insertion by the following 3 measurements: time to perform procedure (minutes), number of levels at which insertion is attempted, and number of ventral passes of the epidural needle.

研究概览

简要总结

Ultrasound scanning of the back has been shown to increase success when used to guide epidural catheter insertion. However, this technique is not applied widely in clinical practice. Stronger evidence is required to prove that it will improve the clinical experience of labour epidurals.

The study hypothesis is that anesthesiologists (both residents and fellows), will have an increased rate of success and ease of insertion of labour epidural catheters, and that there will be increased patient satisfaction, if ultrasound scanning of the lumbar spine is done prior to the procedure.

详细描述

Studies have shown that ultrasound scanning of the lumbar spine is beneficial in certain circumstances (eg. predicted difficult epidurals). However, no large scale studies with multiple anesthesiologists performing the technique have been done to show that ultrasound scanning may be of benefit in their everyday clinical practice.

This study will involve residents and fellows, each performing epidural insertions with and without the use of ultrasound scanning of the lumbar spine prior to the procedure. If the hypothesis is correct, then the use of this technique may become widespread, resulting in less complications and increased patients satisfaction.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • For Patients:
  • Inclusion Criteria:
  • ability to Speak in English
  • requesting epidural analgesia for labour
  • having easily palpable spine (clinically 'easy' back)

排除标准

  • contraindications to epidural analgesia
  • patients with a history of difficult epidural insertions or spinal anesthetic
  • Patients with a known history of back surgery
  • patients with known significant kyph0scoliosis
  • For Anesthesiologists:
  • Inclusion Criteria:
  • Residents and fellows training or practicing at Mount Sinai hospital and enrolled in either a residency or fellowship program at the University of Toronto.

结局指标

主要结局

Ease of epidural insertion by the following 3 measurements: time to perform procedure (minutes), number of levels at which insertion is attempted, and number of ventral passes of the epidural needle.

时间窗: 20 minutes

次要结局

  • The occurrence of inadvertent dural punctures.(24-48 hours)
  • Number of attempts to thread the epidural catheter(20 minutes)
  • Success or failure of the epidural (defined as lack of sufficient analgesia within 2 hours of insertion, necessitating re-insertion)(2 hours)
  • The need of the anesthesiologist to call for assistance with the procedure(30 minutes)
  • Patient satisfaction as determine by a questionnaire(24 hours and 1 week)

研究者

发起方
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
申办方类型
Other

研究点 (2)

Loading locations...

相似试验