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Trial registered on ANZCTR


Registration number
ACTRN12609000346279
Ethics application status
Approved
Date submitted
29/03/2009
Date registered
25/05/2009
Date last updated
4/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ultrasound guided femoral catheter placement for analgesia after major knee surgery: A comparison of two approaches
Scientific title
Optimising Analgesia after Knee Surgery: A comparison of two approaches for femoral nerve catheter placement
Secondary ID [1] 259923 0
FNC09
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain relief after knee surgery 4536 0
Condition category
Condition code
Anaesthesiology 4824 4824 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In-plane needle approach (needle in the plane of the ultrasound beam with ultrasound (US) probe just distal to inguinal crease and needle placed in-line with beam from lateral to medial) for placement of femoral nerve catheters for knee surgery
Approx 15 mins
Primary ropivacaine dose = 100mg
Infusion Ropivacaine = 0.2% at 2 ml/hr and as required 5 ml boluses
Intervention code [1] 4295 0
Treatment: Devices
Comparator / control treatment
Out-of-plane needle approach (needle perpendicular to the plane of the ultrasound beam with US probe just distal to inguinal crease and needle placed in a caudal to cephalad direction) for placement of femoral nerve catheters for knee surgery
Primary ropivacaine dose = 100mg
Infusion Ropivacaine = 0.2% at 2 ml/hr and as required 5 ml boluses
Control group
Active

Outcomes
Primary outcome [1] 5684 0
Pain after knee surgery, assessed by analgesia requirements and numerical rating pain scores (NRPS) postoperatively
Timepoint [1] 5684 0
From time of surgery until Day 2 postoperatively. NRPS and analgesic consumption measured once each on the afternoon of Day 1 and Day 2 following surgery.
Secondary outcome [1] 241583 0
Needle manipulation as measure by needle time under the skin recorded by the investigators
Timepoint [1] 241583 0
At the time of needle insertion until exiting the skin over the catheter

Eligibility
Key inclusion criteria
Patients requiring analgesia for knee surgery under the care of the principal investigator
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient refusal of femoral nerve block. 2. Known neuropathy involving the leg undergoing surgery. 3. Known allergy to amide local anaesthetic drugs.

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)
Initial invitation to participate in the study will occur in the surgeon's rooms. Approximately one week prior to surgery, patients will be contacted by a research assistant to provide further informed consent. Written informed consent will be obtained from all patients. Assignment of the patient to in-plane or out-of-plane needle approach will be delivered in a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised random number generator will be used to assign the patient to one of the 2 groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1703 0
New Zealand
State/province [1] 1703 0
Auckland

Funding & Sponsors
Funding source category [1] 4726 0
Commercial sector/Industry
Name [1] 4726 0
I-Flow Corporation
Address [1] 4726 0
20202 Windrow Drive Lake Forest CA 92630
Country [1] 4726 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] 4271 0
None
Name [1] 4271 0
Address [1] 4271 0
Country [1] 4271 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6769 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 6769 0
P O Box 1031
Hamilton
Waikato Mail Centre 3240
Ethics committee country [1] 6769 0
New Zealand
Date submitted for ethics approval [1] 6769 0
09/03/2009
Approval date [1] 6769 0
31/03/2009
Ethics approval number [1] 6769 0
NTY/09/19/EXP

Summary
Brief summary
If the primary hypothesis is confirmed, this study will provide evidence supporting the 'in-plane' needle approach for femoral catheter placement. Increased exposure of the techniques may promote their uptake in this setting.
Trial website
Trial related presentations / publications
Fredrickson, MJ: Danesh-Clough T K. (Sep 2009) Ambulatory continuous femoral analgesia for major knee surgery: a randomised study of ultrasound-guided femoral catheter placement. Anaesthesia and Intensive Care. Vol: 37(5). pp 758-66
Public notes

Contacts
Principal investigator
Name 29444 0
Dr Michael Fredrickson
Address 29444 0
Anaesthesia Institute
P O Box 109199
Newmarket
Auckland 1149
Country 29444 0
New Zealand
Phone 29444 0
+6495221117
Fax 29444 0
Email 29444 0
anaesthesiainstitute@yahoo.com
Contact person for public queries
Name 12691 0
Dr Dr Michael Fredrickson
Address 12691 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 12691 0
New Zealand
Phone 12691 0
+64 9 522 1117
Fax 12691 0
+64 9 522 1127
Email 12691 0
anaesthesiainstitute@yahoo.com
Contact person for scientific queries
Name 3619 0
Dr Dr Michael Fredrickson
Address 3619 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 3619 0
New Zealand
Phone 3619 0
+64 9 522 1117
Fax 3619 0
+64 9 522 1127
Email 3619 0
anaesthesiainstitute@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary