Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000426482
Ethics application status
Approved
Date submitted
14/08/2007
Date registered
22/08/2007
Date last updated
22/08/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Selective nerve blocks to relieve pain of knee arthritis
Scientific title
Selective nerve blocks to relieve pain of knee arthritis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 2248 0
Condition category
Condition code
Musculoskeletal 2339 2339 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double blind Randomised selective subcutaneous nerve blocks with local anaesthetic or normal saline in 0.5mL aliquots upto maximum 10 mL for complex knee pain in patients awating knee replacement. The trial involves 1 set of injections with the study drug and upto 2 sets of injections with open label 1% lignocaine to determine if pain can be relieved and the duration of pain relief.
Intervention code [1] 1960 0
Treatment: Other
Comparator / control treatment
Normal saline control
Control group
Placebo

Outcomes
Primary outcome [1] 3233 0
Visual Analgue Pain Scale (VAPS) 0-100 pain score
Timepoint [1] 3233 0
Baseline, 2 hour, 1 week, 1, 3, 6 months post treatment
Secondary outcome [1] 5393 0
Brief Pain Inventory
Timepoint [1] 5393 0
Baseline, 2 hour, 1 week, 1, 3, 6 months post treatment
Secondary outcome [2] 5394 0
Medical Outcome Short Form (36) Health Survey (MOS SF36)
Timepoint [2] 5394 0
Baseline, 1 week, 1, 3, 6 months post treatment
Secondary outcome [3] 5395 0
Knee osteoarthritis outcome score (KOOS)
Timepoint [3] 5395 0
Baseline, 1 week, 1, 3, 6 months post treatment

Eligibility
Key inclusion criteria
Waiting list patients with painful knee(s) rated >=5/10 on Verbal Rating Scale (VRS)awaiting knee arthroplasty
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subject on waiting list for a revision knee replacement, has terminal cancer or is unable to communicate or refuses to participate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Block 1: DB random allocation to lignocaine 1% or N-saline injection;
Block 2: Open label 1% lignocaine injection if pain persists 1 week later;
Block 3: option of 2nd open label 1% lignocaine.
Patients obtaining short term pain relief will be offered
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
8/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2507 0
Hospital
Name [1] 2507 0
Frankston Hospital
Country [1] 2507 0
Australia
Primary sponsor type
Individual
Name
Dr Murray Taverner
Address
Frankston Hospital
PO Box 52
Frankston, 3199
Country
Australia
Secondary sponsor category [1] 2276 0
Individual
Name [1] 2276 0
Dr Terence Loughnan
Address [1] 2276 0
Frankston Hospital
PO Box 52
Frankston, 3199
Country [1] 2276 0
Australia
Other collaborator category [1] 5 0
Individual
Name [1] 5 0
Dr Ashley Webb
Address [1] 5 0
Frankston Hospital
PO Box 52
Frankston, 3199
Country [1] 5 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4422 0
Frankston hospital
Ethics committee address [1] 4422 0
Ethics committee country [1] 4422 0
Australia
Date submitted for ethics approval [1] 4422 0
Approval date [1] 4422 0
07/08/2006
Ethics approval number [1] 4422 0
2006-22

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27978 0
Address 27978 0
Country 27978 0
Phone 27978 0
Fax 27978 0
Email 27978 0
Contact person for public queries
Name 11135 0
Dr Murray Taverner
Address 11135 0
Frankston Hospital
PO Box 52
Frankston, 3199
Country 11135 0
Australia
Phone 11135 0
03 9784 7445
Fax 11135 0
03 9784 7441
Email 11135 0
mtaverner@phcn.vic.gov.au
Contact person for scientific queries
Name 2063 0
Dr Murray Taverner
Address 2063 0
Frankston Hospital
PO Box 52
Frankston, 3199
Country 2063 0
Australia
Phone 2063 0
03 9784 7445
Fax 2063 0
03 9784 7441
Email 2063 0
mtaverner@phcn.vic.gov.au

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.