Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000671662
Ethics application status
Approved
Date submitted
19/10/2005
Date registered
21/10/2005
Date last updated
21/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ultrasound guided regional anaesthesia: an audit of practice
Scientific title
Ultrasound guided regional anaesthesia: an audit of practice. That the use of ultrasound to guide needle placement during nerve block insertion improves the success of the procedure and reduces complications
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients who will be receiving nerve blocks as apart of their anaethesia 819 0
Condition category
Condition code
Anaesthesiology 883 883 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The audit proposes to confirm the utliity and efficacy of ultrasound guided regional anaesthesia in our population of patients and in addition to document the complication rates associated with ultrasound guided nerve blocks
Intervention code [1] 727 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 1142 0
1) success of the procedure
Timepoint [1] 1142 0
Primary outcome [2] 1143 0
2) complications
Timepoint [2] 1143 0
Primary outcome [3] 1144 0
3) resource use (time/personnel)
Timepoint [3] 1144 0
Primary outcome [4] 1145 0
4) patient satisfaction
Timepoint [4] 1145 0
Secondary outcome [1] 2106 0
N/A
Timepoint [1] 2106 0

Eligibility
Key inclusion criteria
1) patient requiring local anaesthetic procedure as determined by their proposed operation or need for post-op pain control.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) patient refusal/inability to consent, no age limits2) allergy LA documented3) existing neurological disorders/neuropathy4) infection at site of needle puncture.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 244 0
New Zealand
State/province [1] 244 0

Funding & Sponsors
Funding source category [1] 973 0
Self funded/Unfunded
Name [1] 973 0
Country [1] 973 0
Primary sponsor type
Individual
Name
Principal Investigator Iniatied Trial
Address
Country
Secondary sponsor category [1] 841 0
None
Name [1] 841 0
N/A
Address [1] 841 0
Country [1] 841 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2277 0
Approved by the Norther X Regional Ethics Committee
Ethics committee address [1] 2277 0
Ethics committee country [1] 2277 0
New Zealand
Date submitted for ethics approval [1] 2277 0
Approval date [1] 2277 0
Ethics approval number [1] 2277 0
NTX/05/07/087

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

Contacts
Principal investigator
Name 35820 0
Address 35820 0
Country 35820 0
Phone 35820 0
Fax 35820 0
Email 35820 0
Contact person for public queries
Name 9916 0
Dr Neil MacLennan
Address 9916 0
Department of Anaesthesia
Auckland City Hospital
Level 8
Support Building
Park Road
Grafton Auckland
Country 9916 0
New Zealand
Phone 9916 0
+64 2 74736189
Fax 9916 0
+64 9 3072814
Email 9916 0
nfrmac@xtra.co.nz
Contact person for scientific queries
Name 844 0
Dr Chris Nixon
Address 844 0
Department of Anaesthesia
Auckland City Hospital
Level 8
Support Building
Park Road
Grafton Auckland
Country 844 0
New Zealand
Phone 844 0
+64 2 645369
Fax 844 0
+64 9 3072814
Email 844 0
cnix@xtra.co.nz

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.