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
ACTRN12609000074291
Ethics application status
Approved
Date submitted
20/11/2008
Date registered
30/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of landmark and ultrasound guidance for ankle block placement
Scientific title
Landmark and ultrasound guidance as methods for ankle block placement in patients having elective minor/moderate ankle surgery: A comparison of two endpoints for correct needle tip position
Secondary ID [1] 253061 0
Nil
Secondary ID [2] 259926 0
Ankle
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia following minor/moderate foot surgery 4002 0
Condition category
Condition code
Anaesthesiology 4400 4400 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ankle block placed using ultrasound guidance. Nerve block of the 5 nerves innervating the foot at the level of the ankle. Procedure performed after induction of general anaesthesia but prior to surgery. Ankle block provides both intra and postoperative pain relief (up to 12 hours) for this surgery. Each patient will receive just one ankle block.
Intervention code [1] 3907 0
Treatment: Other
Comparator / control treatment
Ankle block placed using surace landmark guidance. Nerve block of the 5 nerves innervating the foot at the level of the ankle. Procedure performed after induction of general anaesthesia but prior to surgery. Ankle block provides both intra and postoperative pain relief (up to 12 hours) for this surgery. Each patient will receive just one ankle block.
Control group
Active

Outcomes
Primary outcome [1] 5098 0
Analgesic consumption and pain scores during first 24 hours, researcher questioning patient on postoperative day 1.
Assessment tool: numerical rating pain score (0-10)
Timepoint [1] 5098 0
During first 24 hours after the procedure is completed, researcher questioning patient in the afternoon of postoperative day 1.
Primary outcome [2] 5284 0
Time to first pain
Timepoint [2] 5284 0
First 12 hours postoperatively
Secondary outcome [1] 8567 0
Volume of local anaesthetic used/required
Timepoint [1] 8567 0
Duration: from commencement of procedure until completion.: approx 10 min.

Eligibility
Key inclusion criteria
Patients requiring postoperative analgesia following elective minor/moderate foot surgery under the care of the principal investigator.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Patient refusal/inability to consent.
2. Allergy amide local anaesthetic (LA).
3. Existing neurological disorders/neuropathy of the operative extremity.
4. Infection at site of needle puncture.

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)
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] 1393 0
New Zealand
State/province [1] 1393 0
Auckland

Funding & Sponsors
Funding source category [1] 4193 0
Self funded/Unfunded
Name [1] 4193 0
Dr Michael Fredrickson
Address [1] 4193 0
Anaesthesia Institute P O Box 109 199 Newmarket Auckland 1149
Country [1] 4193 0
New Zealand
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] 3767 0
None
Name [1] 3767 0
Address [1] 3767 0
Country [1] 3767 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6250 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 6250 0
P O Box 1031
Hamilton 3240
Waikato
Ethics committee country [1] 6250 0
New Zealand
Date submitted for ethics approval [1] 6250 0
Approval date [1] 6250 0
05/08/2008
Ethics approval number [1] 6250 0
NTY/07/09/103/Ammendment#5

Summary
Brief summary
The purpose of this sub-study is to compare two methods of ankle block placement in patients having elective minor/moderate ankle surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29150 0
Address 29150 0
Country 29150 0
Phone 29150 0
Fax 29150 0
Email 29150 0
Contact person for public queries
Name 12307 0
Dr Michael Fredrickson
Address 12307 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 12307 0
New Zealand
Phone 12307 0
+64 9 522 1117
Fax 12307 0
+64 9 522 1127
Email 12307 0
aiservice@xtra.co.nz
Contact person for scientific queries
Name 3235 0
Dr Michael Fredrickson
Address 3235 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 3235 0
New Zealand
Phone 3235 0
+64 9 522 1117
Fax 3235 0
+64 9 522 1127
Email 3235 0
aiservice@xtra.co.nz

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