Post-Operative Pain Management in Patients Undergoing Uterine Artery Embolisation for Symptomatic Leiomyomata
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
- 否
入选标准
- 未提供
排除标准
- 未提供
