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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Bayside Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163930
First received: September 12, 2005
Last updated: October 2, 2006
Last verified: September 2005
  Purpose

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
Uterine Fibroids

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Post-Operative Pain Management in Patients Undergoing Uterine Artery Embolisation for Symptomatic Leiomyomata

Further study details as provided by Bayside Health:

Study Start Date: January 2005
Estimated Study Completion Date: December 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • na

Exclusion Criteria:

  • na
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163930

Contacts
Contact: Kenneth Thomson, MBBS RANZCR 613 9276 2000 ext 3606 k.thomson@alfred.org.au

Locations
Australia, Victoria
Radiology Department, The Alfred Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Helen Kavnoudias, PhD    61 3 9276 2000 ext 3606    h.kavnoudias@alfred.org.au   
Principal Investigator: Kenneth Thomson, MBBS RANZCR         
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Kenneth Thomson, MBBS RANZCR Bayside Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00163930     History of Changes
Other Study ID Numbers: AlfRad2004-1
Study First Received: September 12, 2005
Last Updated: October 2, 2006
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Bayside Health:
Uterine Fibroids
embolisation
pain management

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Pain, Postoperative
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014