Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* na

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2005
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
Government body
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/study/NCT00163930
Trial related presentations / publications
Konstantatos AH, Kavnoudias H, Stegeman JR, Boyd D, Street M, Bailey M, Lyon SM, Thomson KR. A randomized, double-blind, placebo-controlled study of preemptive oral oxycodone with morphine patient-controlled anesthesia for postoperative pain management in patients undergoing uterine artery embolization for symptomatic uterine fibroids. Cardiovasc Intervent Radiol. 2014 Oct;37(5):1191-7. doi: 10.1007/s00270-014-0913-2. Epub 2014 Jul 1.
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
[email protected]
Contact person for scientific queries



Summary Results

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