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临床试验/NCT00163930
NCT00163930Unknown不适用

Post-Operative Pain Management in Patients Undergoing Uterine Artery Embolisation for Symptomatic Leiomyomata

Bayside Health1 个研究点 分布在 1 个国家开始时间: 2005年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
试验地点
1

研究概览

简要总结

This project seeks to evaluate the effectiveness of a new post-operative pain relief program for women who have undergone uterine artery embolisation (UAE).

UAE is performed by an interventional radiologist as a treatment of uterine fibroids (non-cancerous growths of the uterus.) UAE can be associated with a high level of post-procedural pain and it is the purpose of this study to evaluate a new relief regimen for dealing with this acute pain.

There will be two treatment groups into which patients will be randomly assigned. One will receive the current post-operative therapy (dose-on-demand) and the other will receive the new therapy (pre-emptive dosing). Otherwise patients will receive standard management protocol for this procedure. Only patients that are scheduled for UAE will be enrolled (up to 40 patients).

The new treatment involves giving the patient their morphine dose orally and sixty minutes before the procedure begins (pre-emptive dosing) as opposed to current standard treatment which involves giving the patient a dose of morphine intravenously once they feel pain.

Information to be collected directly from patients includes pain and nausea levels, indicated on a visual scale (a 10 centimetre line showing a spectrum of no pain to worst pain imaginable) as well as their opinions of the effectiveness of the pain relief program and the procedure itself. This information is to be collected immediately post-procedure and at 2, 4, 6 and 24 hours post procedure. Each VAS will take the patient approximately 20 seconds to complete. Information about concurrent medication and procedure complications, post-operative vomiting and respiratory depression will be collected from the patient's history.

详细描述

Post operative Pain Management in Paitents Undergoing Uterine Artery Embolisation for Symptomatic Leiomyomata

Protocol (Ver 2.1)

1.1 Research Question Does pre emptive morphine dosing help reduce acute post operative pain (as expressed on a visual analogue scale, VAS) and/or post operative opioid use in patients undergoing uterine artery embolisation?

2.1 Enrolment Patients are enrolled by Prof Ken Thomson or Dr Stuart Lyon during a planning consultation with each woman. They will be required to sign a consent form if they choose to participate at this point. 3 photocopies of this consent form will be taken, with one copy to go with: the patient; the history; and the data file.

2.2 Exclusions

研究设计

研究类型
Observational
观察模型
Defined Population
时间视角
Other

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究者

发起方
Bayside Health
申办方类型
Other Gov

研究点 (1)

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