Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000417684
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
16/09/2005
Date last updated
14/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective randomised study comparing two techniques for establishing Continuous Femoral Nerve Blockade for postoperative analgesia following Total Knee Joint Replacement
Scientific title
A prospective randomised study comparing a stimulating catheter (StimuCathTM Continuous Nerve Block Set, Arrow International) and a non-stimulating catheter (ContiplexR Tuohy Continuous Nerve Block Set, B. Braun) for establishing Continuous Femoral Nerve Blockade for postoperative analgesia following Total Knee Joint Replacement
Universal Trial Number (UTN)
Trial acronym
StimCath
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative analgesia for Total Knee Joint Replacement 526 0
Condition category
Condition code
Surgery 606 606 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This prospective randomised controlled study has been designed to examine if a stimulating catheter insertion (StimuCathTM Continuous Nerve Block Set, Arrow Internationl) technique improves the quality of Continuous Femoral Nerve Blockade following Total Knee Joint Replacement when compared to non-stimulating catheter insertion (ContiplexR Tuohy Continuous Nerve Block Set, B. Braun). Femoral nerve catheter insitu for no more than 24 hours.
Intervention code [1] 434 0
Treatment: Devices
Comparator / control treatment
Non-stimulating nerve block
Control group
Active

Outcomes
Primary outcome [1] 705 0
Postoperative pain assessment
Timepoint [1] 705 0
At 24 hours postop
Primary outcome [2] 706 0
Postoperative morphine requirements
Timepoint [2] 706 0
At 24 hours postop
Secondary outcome [1] 1450 0
Quality of the femoral nerve block.
Timepoint [1] 1450 0
Day 2 post op

Eligibility
Key inclusion criteria
Patients undergoing primary Total Knee Joint Replacement.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous opioid dependence and/or chronic pain syndrome.Allergy or sensitivity to any study drugs including cycloosygenase inhibitors.BMI > 38 and the inability to palpate landmarks.Inability to comprehend a VAS scale or use of patient controlled analgesia (PCA).Any contraindication to femoral nerve block.

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 envelopes opened at the time of randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software PC-Plan was used to generate random allocation in blocks.
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 662 0
Self funded/Unfunded
Name [1] 662 0
Country [1] 662 0
Primary sponsor type
Hospital
Name
Department of Anaesthesia, St Vincent's Hospital Melbourne
Address
Fitzroy
Country
Australia
Secondary sponsor category [1] 552 0
None
Name [1] 552 0
No secondary sponsor
Address [1] 552 0
Country [1] 552 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35200 0
Address 35200 0
Country 35200 0
Phone 35200 0
Fax 35200 0
Email 35200 0
Contact person for public queries
Name 9623 0
Ms Simone Said
Address 9623 0
Department of Anaesthesia
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy VIC 3065
Country 9623 0
Australia
Phone 9623 0
+61 3 92884245
Fax 9623 0
Email 9623 0
michael.BARRINGTON@svhm.org.au
Contact person for scientific queries
Name 551 0
Dr Michael Barrington
Address 551 0
Department of Anaesthesia
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy VIC 3065
Country 551 0
Australia
Phone 551 0
+61 3 92882211
Fax 551 0
Email 551 0
michael.BARRINGTON@svhm.org.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.