Post-Operative Pain Management in Patients Undergoing Uterine Artery Embolisation for Symptomatic Leiomyomata
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00163930|
Recruitment Status : Unknown
Verified September 2005 by Bayside Health.
Recruitment status was: Recruiting
First Posted : September 14, 2005
Last Update Posted : October 3, 2006
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.
|Condition or disease|
|Study Type :||Observational|
|Observational Model:||Defined Population|
|Official Title:||Post-Operative Pain Management in Patients Undergoing Uterine Artery Embolisation for Symptomatic Leiomyomata|
|Study Start Date :||January 2005|
|Study Completion Date :||December 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163930
|Contact: Kenneth Thomson, MBBS RANZCR||613 9276 2000 ext email@example.com|
|Radiology Department, The Alfred||Recruiting|
|Melbourne, Victoria, Australia, 3004|
|Contact: Helen Kavnoudias, PhD 61 3 9276 2000 ext 3606 firstname.lastname@example.org|
|Principal Investigator: Kenneth Thomson, MBBS RANZCR|
|Principal Investigator:||Kenneth Thomson, MBBS RANZCR||Bayside Health|