Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000376347
Ethics application status
Approved
Date submitted
21/07/2008
Date registered
31/07/2008
Date last updated
1/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of ultrasound and nerve stimulation for femoral catheter placement
Scientific title
Nerve stimulation in ultrasound guided femoral catheter placement. A comparison of two endpoints for correct needle tip position.
Secondary ID [1] 259931 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia following major knee surgery 3430 0
Condition category
Condition code
Anaesthesiology 3585 3585 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Femoral nerve catheter placed using either ultrasound or nerve stimulation, needle endpoint.

Ultrasound placement
Needle will be placed just posterior to the femoral nerve using ultrasound imaging then catheter threaded 3 cm past needle tip.

Nerve stimulation placement
Needle will be placed such that a patella response is present at <0.5 mA. Catheter is then threaded 3 cm beyond needle tip.

The duration of each procedure is 15 minutes, and the period of overall intervention is 48 hours.
Intervention code [1] 3163 0
Treatment: Devices
Comparator / control treatment
Neurostimulation needle endpoint.
Control group
Active

Outcomes
Primary outcome [1] 4488 0
Pain scores during first 48 hours, researcher questioning patient on days 1 and 2. Assessment tool nurse-reported pain score (NRPS), numerical rating pain score (0-10).
Timepoint [1] 4488 0
During first 48 hours after the procedure is completed, researcher questioning patient in the afternoon of days 1 and 2.
Secondary outcome [1] 7595 0
Needle time under the skin at femoral nerve catheter (FNC) insertion
Timepoint [1] 7595 0
At time of FNC insertion

Eligibility
Key inclusion criteria
Patients requiring continuous femoral analgesia following elective knee surgery under the care of the principal investigator
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Patient refusal/inability to consent
2. Allergy amide LA drugs
3. Existing neurological disorders/neuropathy of the operative extremity
4. Infection at site of needle puncture
5. Ischaemic heart disease
6. Chronic opioid therapy

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)
Subjects will be recruited from/by:
1. Surgeon in his rooms
2. By selection from the operation list
3. By phone call during the week prior to surgery
4. By Participant Information Sheet mailed during the week prior to surgery
Allocation of treatment by randomised number generator to assign the patient to one of the 2 groups. Allocation is concealed in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2008
Actual
31/03/2008
Date of last participant enrolment
Anticipated
Actual
18/12/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1047 0
New Zealand
State/province [1] 1047 0
Auckland

Funding & Sponsors
Funding source category [1] 3617 0
Hospital
Name [1] 3617 0
Anaesthesia Research Trust
Country [1] 3617 0
New Zealand
Funding source category [2] 4354 0
Commercial sector/Industry
Name [2] 4354 0
I-Flow Corporation
Country [2] 4354 0
United States of America
Primary sponsor type
Individual
Name
Dr Michael Fredrickson
Address
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country
New Zealand
Secondary sponsor category [1] 3251 0
None
Name [1] 3251 0
Address [1] 3251 0
Country [1] 3251 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5665 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 5665 0
P O Box 1031
Hamilton
Waikato
Ethics committee country [1] 5665 0
New Zealand
Date submitted for ethics approval [1] 5665 0
Approval date [1] 5665 0
31/03/2008
Ethics approval number [1] 5665 0
NTY/07/09/103

Summary
Brief summary
To compare two techniques for femoral nerve catheter placement: Ultrasound only and ultrasound combined with nerve stimulation. To compare the effect of these two placement methods on catheter placement time and the indices of catheter effectiveness. Secondary outcome measures will include degree of patient discomfort during insertion and number of needle passes needed for catheter insertion.
The use of fluid spread as an end point for correct needle tip position would result in more efficient femoral nerve catheter placement while providing a catheter success rate comparable to that based on a neurostimulatory endpoint.
If the primary hypothesis is confirmed, this study will provide evidence supporting the use of ultrasound only (without nerve stimulation) as an end point for interscalene catheter placement. At present the community standard is nerve stimulation. This may result in future patients undergoing catheter insertions with reduced needle passes. Potential benefits might include more efficient catheter placements, with less discomfort and with possibly a reduced incidence of short term neurological sequelae.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28767 0
Dr Michael Fredrickson
Address 28767 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 28767 0
New Zealand
Phone 28767 0
+6495221117
Fax 28767 0
Email 28767 0
[email protected]
Contact person for public queries
Name 11924 0
Dr Michael Fredrickson
Address 11924 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 11924 0
New Zealand
Phone 11924 0
0064 9 522 1117
Fax 11924 0
0064 9 522 1127
Email 11924 0
[email protected]
Contact person for scientific queries
Name 2852 0
Dr Michael Fredrickson
Address 2852 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 2852 0
New Zealand
Phone 2852 0
0064 9 522 1117
Fax 2852 0
0064 9 522 1127
Email 2852 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.