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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. 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
Information provided by:
Bayside Health

Brief Summary:

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
Uterine Fibroids

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Study Type : Observational
Observational Model: Defined Population
Time Perspective: Other
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

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • na

Exclusion Criteria:

  • na

Information from the National Library of Medicine

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 identifier (NCT number): NCT00163930

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Contact: Kenneth Thomson, MBBS RANZCR 613 9276 2000 ext 3606

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Australia, Victoria
Radiology Department, The Alfred Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Helen Kavnoudias, PhD    61 3 9276 2000 ext 3606   
Principal Investigator: Kenneth Thomson, MBBS RANZCR         
Sponsors and Collaborators
Bayside Health
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Principal Investigator: Kenneth Thomson, MBBS RANZCR Bayside Health
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00163930    
Other Study ID Numbers: AlfRad2004-1
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: October 3, 2006
Last Verified: September 2005
Keywords provided by Bayside Health:
Uterine Fibroids
pain management
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases