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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00163930




Registration number
NCT00163930
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
3/10/2006

Titles & IDs
Public title
Post-Operative Pain Management in Patients Undergoing Uterine Artery Embolisation for Symptomatic Leiomyomata
Scientific title
Post-Operative Pain Management in Patients Undergoing Uterine Artery Embolisation for Symptomatic Leiomyomata
Secondary ID [1] 0 0
AlfRad2004-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine Fibroids 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- na
Minimum age
18 Years
Maximum age
80 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- na

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Radiology Department, The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00163930
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kenneth Thomson, MBBS RANZCR
Address 0 0
Bayside Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kenneth Thomson, MBBS RANZCR
Address 0 0
Country 0 0
Phone 0 0
613 9276 2000
Fax 0 0
Email 0 0
k.thomson@alfred.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00163930