Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000088347
Ethics application status
Approved
Date submitted
13/02/2008
Date registered
15/02/2008
Date last updated
15/02/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Post Amputation Phantom Limb Pain Study
Scientific title
Can Pregabalin prevent persistent post amputation pain?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent phantom limb pain post amputation 2828 0
Condition category
Condition code
Anaesthesiology 2961 2961 0 0
Pain management
Anaesthesiology 2962 2962 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One month course of oral pregabalin commencing with a single preoperative 150md dose of pregabalin, followed by 75mg oral pregabalin BD for 7 days after surgery, then increasing to 75-150mg bd for the following 21 days, a total of 28 days of pregabalin
Intervention code [1] 2562 0
Prevention
Comparator / control treatment
Placebo- calcium carbonate packaged to appear identical to the pregabalin capsule
Control group
Placebo

Outcomes
Primary outcome [1] 3840 0
reduction of incidence of phantom pain in treatment group using chi square testing: significant pain versus no significant pain
Timepoint [1] 3840 0
1 week, one month and six months post amputation surgery
Secondary outcome [1] 6468 0
improvement in acute postoperative pain which will be measured using the verbal response scale (VRS)
Timepoint [1] 6468 0
24hrs, 48hrs, 1 week post surgery
Secondary outcome [2] 6469 0
improvements in analgesic requirements after discharge from acute care hospital
Timepoint [2] 6469 0
10days, 1 month, 6 months
Secondary outcome [3] 6470 0
improvement in psychological status after lower limb amputation
Timepoint [3] 6470 0
24hrs, 48hrs, 1 week, 1 month and 6 months post surgery measured using the Hospital and anxiety scale (HADS)

Eligibility
Key inclusion criteria
Patient able to provide own informed consent.
there is sufficient ime before proposed surgery to allow absorption of loading dose of pregabalin, minimum 2hrs
Patient is suitable for standard general anaesthetic (GA) regimen and able to use patient controlled analgesia (PCA) for postop analgesia
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current use of gabapentin
Unable to give consent
epilepsy
pregnancy
lactation
significant renal impairment
galactos metabolic disorders

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permutted blocks with stratified allocation by site
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 767 0
2139
Recruitment postcode(s) [2] 768 0
3000
Recruitment postcode(s) [3] 769 0
2305

Funding & Sponsors
Funding source category [1] 3085 0
Commercial sector/Industry
Name [1] 3085 0
Pfizer Inc
Country [1] 3085 0
United States of America
Primary sponsor type
Hospital
Name
John Hunter Hospital-Hunter Integrated Pain Service
Address
Level 2 Exectutive Suite, Royal Newcastle Centre
Lookout Rd
New Lambton NSW 2305
Country
Australia
Secondary sponsor category [1] 2778 0
Government body
Name [1] 2778 0
Hunter New England Area Health Service
Address [1] 2778 0
Locked bag 1
Lookout Rd
New Lambton NSW 2305
Country [1] 2778 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5033 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 5033 0
Locked bag 1
New Lambton NSW 2305
Ethics committee country [1] 5033 0
Australia
Date submitted for ethics approval [1] 5033 0
27/05/2006
Approval date [1] 5033 0
21/08/2006
Ethics approval number [1] 5033 0
06/06/28/3.02

Summary
Brief summary
The aim of the study is to determine whether the use of the drug Pregabalin can reduce or eliminate phantom pain after leg amputations
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28371 0
Address 28371 0
Country 28371 0
Phone 28371 0
Fax 28371 0
Email 28371 0
Contact person for public queries
Name 11528 0
Jeanene Douglas
Address 11528 0
Hunter Integrated Pain Service
Level 2 Executive Suite, Royal Newcastle Centre
Lookout Rd
New Lambton NSW 2305
Country 11528 0
Australia
Phone 11528 0
61 2 49223435
Fax 11528 0
61 2 49223574
Email 11528 0
[email protected]
Contact person for scientific queries
Name 2456 0
Dr Richard Burstal
Address 2456 0
Hunter Integrated Pain Service
Level 2 Executive Suite, Royal Newcastle Centre
Lookout Rd
New Lambton NSW 2305
Country 2456 0
Australia
Phone 2456 0
61 2 49223435
Fax 2456 0
61 2 49223574
Email 2456 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.